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NCT00943722 · OUTCOME

Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine

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.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to ~Month 126

What was measured

Serum antibody titers for HPV VLPs Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined and reported in milli Merck Units/mL. The percentage of participants seropositive to each HPV type was reported. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.

Analysis population: All participants who met the 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.

Groups in this outcome

Extension Study: 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 studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).

Extension Study: 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 studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Extension Study: 9- to 15-Year-Old Females971
Extension Study: 9- to 15-Year-Old Males301

Reported measurements

Anti-HPV 6

Analysis denominator · Participants

GroupSource count
Extension Study: 9- to 15-Year-Old Females341
Extension Study: 9- to 15-Year-Old Males176
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females82.7Not reported78.386.6Not reported
Extension Study: 9- to 15-Year-Old Males84.1Not reported77.889.2Not reported
Anti-HPV 11

Analysis denominator · Participants

GroupSource count
Extension Study: 9- to 15-Year-Old Females332
Extension Study: 9- to 15-Year-Old Males169
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females85.2Not reported81.088.9Not reported
Extension Study: 9- to 15-Year-Old Males87.0Not reported81.091.7Not reported
Anti-HPV 16

Analysis denominator · Participants

GroupSource count
Extension Study: 9- to 15-Year-Old Females338
Extension Study: 9- to 15-Year-Old Males173
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females97.3Not reported95.098.8Not reported
Extension Study: 9- to 15-Year-Old Males98.3Not reported95.099.6Not reported
Anti-HPV 18

Analysis denominator · Participants

GroupSource count
Extension Study: 9- to 15-Year-Old Females347
Extension Study: 9- to 15-Year-Old Males178
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females80.1Not reported75.584.2Not reported
Extension Study: 9- to 15-Year-Old Males83.7Not reported77.488.8Not reported
Anti-HPV 31

Analysis denominator · Participants

GroupSource count
Extension Study: 9- to 15-Year-Old Females343
Extension Study: 9- to 15-Year-Old Males177
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females90.1Not reported86.493.0Not reported
Extension Study: 9- to 15-Year-Old Males92.7Not reported87.896.0Not reported
Anti-HPV 33

Analysis denominator · Participants

GroupSource count
Extension Study: 9- to 15-Year-Old Females344
Extension Study: 9- to 15-Year-Old Males178
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females85.2Not reported81.088.8Not reported
Extension Study: 9- to 15-Year-Old Males89.3Not reported83.893.4Not reported
Anti-HPV 45

Analysis denominator · Participants

GroupSource count
Extension Study: 9- to 15-Year-Old Females325
Extension Study: 9- to 15-Year-Old Males169
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females81.8Not reported77.285.9Not reported
Extension Study: 9- to 15-Year-Old Males92.3Not reported87.295.8Not reported
Anti-HPV 52

Analysis denominator · Participants

GroupSource count
Extension Study: 9- to 15-Year-Old Females348
Extension Study: 9- to 15-Year-Old Males176
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females88.2Not reported84.491.4Not reported
Extension Study: 9- to 15-Year-Old Males89.2Not reported83.793.4Not reported
Anti-HPV 58

Analysis denominator · Participants

GroupSource count
Extension Study: 9- to 15-Year-Old Females342
Extension Study: 9- to 15-Year-Old Males175
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females96.5Not reported94.098.2Not reported
Extension Study: 9- to 15-Year-Old Males97.1Not reported93.599.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        78.3
        upper Limit
        86.6
        value
        82.7
      2. group Id
        OG001
        lower Limit
        77.8
        upper Limit
        89.2
        value
        84.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        341
      2. group Id
        OG001
        value
        176
      units
      Participants
    title
    Anti-HPV 6
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        81.0
        upper Limit
        88.9
        value
        85.2
      2. group Id
        OG001
        lower Limit
        81.0
        upper Limit
        91.7
        value
        87.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        332
      2. group Id
        OG001
        value
        169
      units
      Participants
    title
    Anti-HPV 11
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        95.0
        upper Limit
        98.8
        value
        97.3
      2. group Id
        OG001
        lower Limit
        95.0
        upper Limit
        99.6
        value
        98.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        338
      2. group Id
        OG001
        value
        173
      units
      Participants
    title
    Anti-HPV 16
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        75.5
        upper Limit
        84.2
        value
        80.1
      2. group Id
        OG001
        lower Limit
        77.4
        upper Limit
        88.8
        value
        83.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        347
      2. group Id
        OG001
        value
        178
      units
      Participants
    title
    Anti-HPV 18
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        86.4
        upper Limit
        93.0
        value
        90.1
      2. group Id
        OG001
        lower Limit
        87.8
        upper Limit
        96.0
        value
        92.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        343
      2. group Id
        OG001
        value
        177
      units
      Participants
    title
    Anti-HPV 31
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        81.0
        upper Limit
        88.8
        value
        85.2
      2. group Id
        OG001
        lower Limit
        83.8
        upper Limit
        93.4
        value
        89.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        344
      2. group Id
        OG001
        value
        178
      units
      Participants
    title
    Anti-HPV 33
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77.2
        upper Limit
        85.9
        value
        81.8
      2. group Id
        OG001
        lower Limit
        87.2
        upper Limit
        95.8
        value
        92.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        325
      2. group Id
        OG001
        value
        169
      units
      Participants
    title
    Anti-HPV 45
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        84.4
        upper Limit
        91.4
        value
        88.2
      2. group Id
        OG001
        lower Limit
        83.7
        upper Limit
        93.4
        value
        89.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        348
      2. group Id
        OG001
        value
        176
      units
      Participants
    title
    Anti-HPV 52
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        94.0
        upper Limit
        98.2
        value
        96.5
      2. group Id
        OG001
        lower Limit
        93.5
        upper Limit
        99.1
        value
        97.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      2. group Id
        OG001
        value
        175
      units
      Participants
    title
    Anti-HPV 58
denoms
  1. counts
    1. group Id
      OG000
      value
      971
    2. group Id
      OG001
      value
      301
    units
    Participants
description
Serum antibody titers for HPV VLPs Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined and reported in milli Merck Units/mL. The percentage of participants seropositive to each HPV type was reported. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
dispersion Type
95% Confidence Interval
groups
  1. 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 studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
    id
    OG000
    title
    Extension Study: 9- to 15-Year-Old Females
  2. 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 studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2)
    id
    OG001
    title
    Extension Study: 9- to 15-Year-Old Males
param Type
NUMBER
population Description
All participants who met the 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.
reporting Status
POSTED
time Frame
Up to ~Month 126
title
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
type
PRIMARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice