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NCT00943722 · ADVERSE EVENTS

Adverse events

A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002) · Source last updated 2022-10-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Other-event reporting threshold
5%

Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Base Study: 9- to 15-Year-Old Females (Lot 1)

9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.

6 / 643538 / 6430 / 648
Base Study: 9- to 15-Year-Old Females (Lot 2)

9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.

2 / 639537 / 6390 / 643
Base Study: 9- to 15-Year-Old Females (Lot 3)

9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.

8 / 641554 / 6410 / 644
Base Study: 9- to 15-Year-Old Males (Lot 1)

9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.

11 / 662505 / 6620 / 669
Base Study: 16- to 26-Year-Old Females (Lot 1)

9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.

15 / 466404 / 4660 / 470
EXT1: 9- to 15-Year-Old Females

In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1).

2 / 16040 / 16041 / 1604
EXT1: 9- to 15-Year-Old Males

In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1).

0 / 5680 / 5680 / 568
EXT2: 9- to 15-Year-Old Females

In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).

3 / 9710 / 9711 / 971
EXT2: 9- to 15-Year-Old Males

In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).

0 / 3010 / 3010 / 301

Group identifiers: EG000: Base Study: 9- to 15-Year-Old Females (Lot 1) · EG001: Base Study: 9- to 15-Year-Old Females (Lot 2) · EG002: Base Study: 9- to 15-Year-Old Females (Lot 3) · EG003: Base Study: 9- to 15-Year-Old Males (Lot 1) · EG004: Base Study: 16- to 26-Year-Old Females (Lot 1) · EG005: EXT1: 9- to 15-Year-Old Females · EG006: EXT1: 9- to 15-Year-Old Males · EG007: EXT2: 9- to 15-Year-Old Females · EG008: EXT2: 9- to 15-Year-Old Males

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      641
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      466
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      641
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Colitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      643
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      641
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Colitis ulcerative
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      641
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Gastritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      641
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      641
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      466
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Biliary colic
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      643
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      639
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      641
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      662
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Appendicitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      641
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      971
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Disseminated tuberculosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      641
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      662
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Gastroenteritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      641
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Gastrointestinal infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      641
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Infectious mononucleosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      641
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Paronychia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      184
      num At Risk
      643
      num Events
      264
    2. group Id
      EG001
      num Affected
      192
      num At Risk
      639
      num Events
      287
    3. group Id
      EG002
      num Affected
      195
      num At Risk
      641
      num Events
      281
    4. group Id
      EG003
      num Affected
      159
      num At Risk
      662
      num Events
      219
    5. group Id
      EG004
      num Affected
      132
      num At Risk
      466
      num Events
      220
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Injection site erythema
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      506
      num At Risk
      643
      num Events
      1166
    2. group Id
      EG001
      num Affected
      513
      num At Risk
      639
      num Events
      1183
    3. group Id
      EG002
      num Affected
      529
      num At Risk
      641
      num Events
      1215
    4. group Id
      EG003
      num Affected
      465
      num At Risk
      662
      num Events
      919
    5. group Id
      EG004
      num Affected
      393
      num At Risk
      466
      num Events
      970
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Injection site pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      207
      num At Risk
      643
      num Events
      317
    2. group Id
      EG001
      num Affected
      237
      num At Risk
      639
      num Events
      372
    3. group Id
      EG002
      num Affected
      226
      num At Risk
      641
      num Events
      380
    4. group Id
      EG003
      num Affected
      173
      num At Risk
      662
      num Events
      249
    5. group Id
      EG004
      num Affected
      150
      num At Risk
      466
      num Events
      261
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Injection site swelling
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      643
      num Events
      91
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      639
      num Events
      67
    3. group Id
      EG002
      num Affected
      64
      num At Risk
      641
      num Events
      74
    4. group Id
      EG003
      num Affected
      84
      num At Risk
      662
      num Events
      94
    5. group Id
      EG004
      num Affected
      43
      num At Risk
      466
      num Events
      53
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      643
      num Events
      182
    2. group Id
      EG001
      num Affected
      122
      num At Risk
      639
      num Events
      170
    3. group Id
      EG002
      num Affected
      113
      num At Risk
      641
      num Events
      156
    4. group Id
      EG003
      num Affected
      98
      num At Risk
      662
      num Events
      143
    5. group Id
      EG004
      num Affected
      106
      num At Risk
      466
      num Events
      166
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Headache
Complete source fields
description
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    648
    description
    9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
    id
    EG000
    other Num Affected
    538
    other Num At Risk
    643
    serious Num Affected
    6
    serious Num At Risk
    643
    title
    Base Study: 9- to 15-Year-Old Females (Lot 1)
  2. deaths Num Affected
    0
    deaths Num At Risk
    643
    description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
    id
    EG001
    other Num Affected
    537
    other Num At Risk
    639
    serious Num Affected
    2
    serious Num At Risk
    639
    title
    Base Study: 9- to 15-Year-Old Females (Lot 2)
  3. deaths Num Affected
    0
    deaths Num At Risk
    644
    description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
    id
    EG002
    other Num Affected
    554
    other Num At Risk
    641
    serious Num Affected
    8
    serious Num At Risk
    641
    title
    Base Study: 9- to 15-Year-Old Females (Lot 3)
  4. deaths Num Affected
    0
    deaths Num At Risk
    669
    description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
    id
    EG003
    other Num Affected
    505
    other Num At Risk
    662
    serious Num Affected
    11
    serious Num At Risk
    662
    title
    Base Study: 9- to 15-Year-Old Males (Lot 1)
  5. deaths Num Affected
    0
    deaths Num At Risk
    470
    description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
    id
    EG004
    other Num Affected
    404
    other Num At Risk
    466
    serious Num Affected
    15
    serious Num At Risk
    466
    title
    Base Study: 16- to 26-Year-Old Females (Lot 1)
  6. deaths Num Affected
    1
    deaths Num At Risk
    1604
    description
    In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1).
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    1604
    serious Num Affected
    2
    serious Num At Risk
    1604
    title
    EXT1: 9- to 15-Year-Old Females
  7. deaths Num Affected
    0
    deaths Num At Risk
    568
    description
    In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1).
    id
    EG006
    other Num Affected
    0
    other Num At Risk
    568
    serious Num Affected
    0
    serious Num At Risk
    568
    title
    EXT1: 9- to 15-Year-Old Males
  8. deaths Num Affected
    1
    deaths Num At Risk
    971
    description
    In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
    id
    EG007
    other Num Affected
    0
    other Num At Risk
    971
    serious Num Affected
    3
    serious Num At Risk
    971
    title
    EXT2: 9- to 15-Year-Old Females
  9. deaths Num Affected
    0
    deaths Num At Risk
    301
    description
    In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
    id
    EG008
    other Num Affected
    0
    other Num At Risk
    301
    serious Num Affected
    0
    serious Num At Risk
    301
    title
    EXT2: 9- to 15-Year-Old Males
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      184
      num At Risk
      643
      num Events
      264
    2. group Id
      EG001
      num Affected
      192
      num At Risk
      639
      num Events
      287
    3. group Id
      EG002
      num Affected
      195
      num At Risk
      641
      num Events
      281
    4. group Id
      EG003
      num Affected
      159
      num At Risk
      662
      num Events
      219
    5. group Id
      EG004
      num Affected
      132
      num At Risk
      466
      num Events
      220
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Injection site erythema
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      506
      num At Risk
      643
      num Events
      1166
    2. group Id
      EG001
      num Affected
      513
      num At Risk
      639
      num Events
      1183
    3. group Id
      EG002
      num Affected
      529
      num At Risk
      641
      num Events
      1215
    4. group Id
      EG003
      num Affected
      465
      num At Risk
      662
      num Events
      919
    5. group Id
      EG004
      num Affected
      393
      num At Risk
      466
      num Events
      970
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Injection site pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      207
      num At Risk
      643
      num Events
      317
    2. group Id
      EG001
      num Affected
      237
      num At Risk
      639
      num Events
      372
    3. group Id
      EG002
      num Affected
      226
      num At Risk
      641
      num Events
      380
    4. group Id
      EG003
      num Affected
      173
      num At Risk
      662
      num Events
      249
    5. group Id
      EG004
      num Affected
      150
      num At Risk
      466
      num Events
      261
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Injection site swelling
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      643
      num Events
      91
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      639
      num Events
      67
    3. group Id
      EG002
      num Affected
      64
      num At Risk
      641
      num Events
      74
    4. group Id
      EG003
      num Affected
      84
      num At Risk
      662
      num Events
      94
    5. group Id
      EG004
      num Affected
      43
      num At Risk
      466
      num Events
      53
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      643
      num Events
      182
    2. group Id
      EG001
      num Affected
      122
      num At Risk
      639
      num Events
      170
    3. group Id
      EG002
      num Affected
      113
      num At Risk
      641
      num Events
      156
    4. group Id
      EG003
      num Affected
      98
      num At Risk
      662
      num Events
      143
    5. group Id
      EG004
      num Affected
      106
      num At Risk
      466
      num Events
      166
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Headache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      641
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      466
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      641
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Colitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      643
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      641
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Colitis ulcerative
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      641
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Gastritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      641
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      641
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      466
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Biliary colic
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      643
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      639
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      641
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      662
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Appendicitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      641
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      971
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Disseminated tuberculosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      641
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      662
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Gastroenteritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      641
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Gastrointestinal infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      641
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Infectious mononucleosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      643
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      639
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      641
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      662
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      466
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1604
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      568
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      971
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      301
      num Events
      0
    term
    Paronychia
time Frame
Base Study: Up to ~12 months; Extension Study: Up to ~126 months

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Preserved source evidence · Not medical advice