TriangleNCT00943722 · STUDY IN CONTEXT
A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.
Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.
Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers were reported in milli Merck Units/mL.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine was also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine was also an AE. Systemic AEs were those not categorized as injection-site AEs.
Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- trial label
- A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 9
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0000
- source section id
- NCT00943722-om-0000
- source outcome index
- 0
- endpoint
- Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
- endpoint definition
- Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.
- time origin
- 4 weeks post-vaccination 3 (Month 7)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0001
- source section id
- NCT00943722-om-0001
- source outcome index
- 1
- endpoint
- Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
- endpoint definition
- Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.
- time origin
- 4 weeks post-vaccination 3 (Month 7)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0002
- source section id
- NCT00943722-om-0002
- source outcome index
- 2
- endpoint
- Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
- endpoint definition
- Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers were reported in milli Merck Units/mL.
- time origin
- 4 weeks post-vaccination 3 (Month 7)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 9-15-year-old females who received 3 vaccinations from Lots 1, 2, or 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0003
- source section id
- NCT00943722-om-0003
- source outcome index
- 3
- endpoint
- Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs)
- endpoint definition
- An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine was also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
- time origin
- Up to 5 days after any vaccination
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0004
- source section id
- NCT00943722-om-0004
- source outcome index
- 4
- endpoint
- Base Study: Percentage of Participants With Systemic AEs
- endpoint definition
- An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine was also an AE. Systemic AEs were those not categorized as injection-site AEs.
- time origin
- Up to 15 days after any vaccination
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0005
- source section id
- NCT00943722-om-0005
- source outcome index
- 5
- endpoint
- Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)
- endpoint definition
- Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.
- time origin
- Up to 5 days after any vaccination
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Base Study: 9- to 15-Year-Old Females (Lot 1)
- regimen
- 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.
- analyzed count
- 535
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00943722-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Base Study: 9- to 15-Year-Old Males (Lot 1)
- regimen
- 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.
- analyzed count
- 378
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00943722-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Base Study: 9- to 15-Year-Old Males (Lot 1)
- regimen
- 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.
- analyzed count
- 570
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00943722-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Base Study: 16- to 26-Year-Old Females (Lot 1)
- regimen
- 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.
- analyzed count
- 378
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00943722-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Base Study: 9- to 15-Year-Old Females (Lot 1)
- regimen
- 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.
- analyzed count
- 535
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00943722-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Base Study: 9- to 15-Year-Old Females (Lot 2)
- regimen
- 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.
- analyzed count
- 549
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00943722-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Base Study: 9- to 15-Year-Old Females (Lot 3)
- regimen
- 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.
- analyzed count
- 565
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00943722-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0003
- arm key
- OG000
- arm label
- 9- to 15-Year-Old Females (Lots 1, 2 or 3)
- regimen
- 9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
- analyzed count
- 1923
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00943722-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Base Study: 9- to 15-Year-Old Males (Lot 1)
- regimen
- 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.
- analyzed count
- 662
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00943722-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Base Study: 16- to 26-Year-Old Females (Lot 1)
- regimen
- 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.
- analyzed count
- 466
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00943722-om-0003#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0004
- arm key
- OG000
- arm label
- 9- to 15-Year-Old Females (Lots 1, 2 or 3)
- regimen
- 9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
- analyzed count
- 1923
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00943722-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Base Study: 9- to 15-Year-Old Males (Lot 1)
- regimen
- 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.
- analyzed count
- 662
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00943722-om-0004#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- harm key
- EG000
- source section id
- NCT00943722-ae
- event group key
- EG000
- event group label
- Base Study: 9- to 15-Year-Old Females (Lot 1)
- serious affected
- 6
- serious at risk
- 643
- other affected
- 538
- other at risk
- 643
- frequency threshold
- 5
- collection period
- Base Study: Up to ~12 months; Extension Study: Up to ~126 months
- event definition
- 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).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- harm key
- EG001
- source section id
- NCT00943722-ae
- event group key
- EG001
- event group label
- Base Study: 9- to 15-Year-Old Females (Lot 2)
- serious affected
- 2
- serious at risk
- 639
- other affected
- 537
- other at risk
- 639
- frequency threshold
- 5
- collection period
- Base Study: Up to ~12 months; Extension Study: Up to ~126 months
- event definition
- 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).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- harm key
- EG002
- source section id
- NCT00943722-ae
- event group key
- EG002
- event group label
- Base Study: 9- to 15-Year-Old Females (Lot 3)
- serious affected
- 8
- serious at risk
- 641
- other affected
- 554
- other at risk
- 641
- frequency threshold
- 5
- collection period
- Base Study: Up to ~12 months; Extension Study: Up to ~126 months
- event definition
- 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).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- harm key
- EG003
- source section id
- NCT00943722-ae
- event group key
- EG003
- event group label
- Base Study: 9- to 15-Year-Old Males (Lot 1)
- serious affected
- 11
- serious at risk
- 662
- other affected
- 505
- other at risk
- 662
- frequency threshold
- 5
- collection period
- Base Study: Up to ~12 months; Extension Study: Up to ~126 months
- event definition
- 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).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- harm key
- EG004
- source section id
- NCT00943722-ae
- event group key
- EG004
- event group label
- Base Study: 16- to 26-Year-Old Females (Lot 1)
- serious affected
- 15
- serious at risk
- 466
- other affected
- 404
- other at risk
- 466
- frequency threshold
- 5
- collection period
- Base Study: Up to ~12 months; Extension Study: Up to ~126 months
- event definition
- 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).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- harm key
- EG005
- source section id
- NCT00943722-ae
- event group key
- EG005
- event group label
- EXT1: 9- to 15-Year-Old Females
- serious affected
- 2
- serious at risk
- 1604
- other affected
- 0
- other at risk
- 1604
- frequency threshold
- 5
- collection period
- Base Study: Up to ~12 months; Extension Study: Up to ~126 months
- event definition
- 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).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- harm key
- EG006
- source section id
- NCT00943722-ae
- event group key
- EG006
- event group label
- EXT1: 9- to 15-Year-Old Males
- serious affected
- 0
- serious at risk
- 568
- other affected
- 0
- other at risk
- 568
- frequency threshold
- 5
- collection period
- Base Study: Up to ~12 months; Extension Study: Up to ~126 months
- event definition
- 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).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- harm key
- EG007
- source section id
- NCT00943722-ae
- event group key
- EG007
- event group label
- EXT2: 9- to 15-Year-Old Females
- serious affected
- 3
- serious at risk
- 971
- other affected
- 0
- other at risk
- 971
- frequency threshold
- 5
- collection period
- Base Study: Up to ~12 months; Extension Study: Up to ~126 months
- event definition
- 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).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00943722
- harm key
- EG008
- source section id
- NCT00943722-ae
- event group key
- EG008
- event group label
- EXT2: 9- to 15-Year-Old Males
- serious affected
- 0
- serious at risk
- 301
- other affected
- 0
- other at risk
- 301
- frequency threshold
- 5
- collection period
- Base Study: Up to ~12 months; Extension Study: Up to ~126 months
- event definition
- 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).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice