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NCT01047345 · REGISTRY CONDITION SEARCH

A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2018-11-27

This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study

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outcome · POSTED

Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - Base Study

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outcome · POSTED

Percentage of Participants Who Experience a Systemic AE - Base Study

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outcome · POSTED

Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination - Base Study

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outcome · POSTED

Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study- Base Study

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outcome · POSTED

Percentage of Participants Who Experience a Severe Injection-site AE - Base Study

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outcome · POSTED

Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study

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outcome · POSTED

Percentage of Participants Who Experience an SAE- Extension Study

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: Participants Age 12 to 15 Years: * Participant is in good health * Parent/legal guardian and participant agree to provide study personnel with a primary telephone number for follow-up * Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1 * Participant has not received any other HPV vaccine * Participant is not yet sexually active Participants Age 16 to 26 Years: * Participant is in good health * Participant agrees to provide a primary telephone number for follow-up * Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1 * Participant has not received any other HPV vaccine * Participant has never had Papanicolaou (Pap) testing or has only had normal results * Participant has a history of 0 to 4 lifetime sexual partners at enrollment Exclusion Criteria: All participants: * Participant has a history of severe allergic reaction that required medical intervention * Participant has any disorder that would contraindicate intramuscular injections * Participant is pregnant * Participant is immunocompromised or has an autoimmune condition * Participant has had a splenectomy * Participant has received any immune globulin product or blood-derived product * Participant has participated in a HPV vaccine clinical trial Participants Age 16 to 26 Only: * Participant expects to donate eggs during the study * Participant has a history of abnormal cervical biopsy result * Participant has a history of HPV-related external genital lesions, external genital cancer, HPV-related vaginal lesions, or vaginal cancer
healthy Volunteers
true
maximum Age
26 Years
minimum Age
12 Years
sex
FEMALE
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
    intervention Names
    1. Biological: V503
    label
    9vHPV Vaccine
    type
    EXPERIMENTAL
  2. description
    Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
    intervention Names
    1. Biological: V503
    2. Biological: Placebo to V503
    label
    Placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. 9vHPV Vaccine
    2. Placebo
    description
    V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study or the Study Extension
    name
    V503
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Placebo
    description
    Placebo to V503 (saline) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study
    name
    Placebo to V503
    type
    BIOLOGICAL
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
PREVENTION
Enrollment
count
924
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.
    measure
    Percentage of Participants Who Experience an SAE- Extension Study
    time Frame
    up to Month 7 - Extension Study
primary Outcomes
  1. description
    An AE is 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 is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.
    measure
    Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study
    time Frame
    up to 5 days after any vaccination - Base Study
  2. description
    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.
    measure
    Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - Base Study
    time Frame
    up to 5 days after any vaccination - Base Study
  3. description
    An AE is 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 is also an AE. Systemic AEs were those not categorized as injection-site AEs.
    measure
    Percentage of Participants Who Experience a Systemic AE - Base Study
    time Frame
    up to 14 days after any vaccination - Base Study
  4. description
    An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.
    measure
    Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination - Base Study
    time Frame
    up to 14 days after any vaccination - Base Study
  5. description
    An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" is defined as a vaccine-related SAE.
    measure
    Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study- Base Study
    time Frame
    Up to 7 months - Base Study
  6. description
    An AE is 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 is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter \>2 inches (\>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.
    measure
    Percentage of Participants Who Experience a Severe Injection-site AE - Base Study
    time Frame
    up to 5 days after any vaccination - Base Study
secondary Outcomes
  1. description
    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 competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
    measure
    Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
    time Frame
    4 weeks post-vaccination 3 (Month 7; End of Base Study)
Full study description
brief Summary
This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.
Source references
avail Ipds
references
  1. citation
    Garland SM, Cheung TH, McNeill S, Petersen LK, Romaguera J, Vazquez-Narvaez J, Bautista O, Shields C, Vuocolo S, Luxembourg A. Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. Vaccine. 2015 Nov 27;33(48):6855-64. doi: 10.1016/j.vaccine.2015.08.059. Epub 2015 Sep 26.
    pmid
    26411885
    type
    RESULT
  2. citation
    Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.
    pmid
    27422279
    type
    RESULT
  3. citation
    Moreira ED, Giuliano AR, de Hoon J, Iversen OE, Joura EA, Restrepo J, Van Damme P, Vandermeulen C, Ellison MC, Krick A, Shields C, Heiles B, Luxembourg A. Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. Hum Vaccin Immunother. 2018 Feb 1;14(2):396-403. doi: 10.1080/21645515.2017.1403700. Epub 2017 Dec 14.
    pmid
    29211620
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice