Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00943722 · OUTCOME

Extension Study: GMTs For 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
GEOMETRIC_MEAN
Unit
milli Merck Units/mL
Interval / dispersion
95% Confidence Interval
Time frame
Up to ~Month 126

What was measured

Serum antibody titers (milli Merck Units/mL) measured by cLIA to each of the 9vHPV types were assessed. 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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females122.3Not reported111.1134.7Not reported
Extension Study: 9- to 15-Year-Old Males129.5Not reported112.5149.1Not 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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females80.2Not reported72.588.8Not reported
Extension Study: 9- to 15-Year-Old Males91.0Not reported78.4105.6Not reported
Anti-HPV 16

Analysis denominator · Participants

GroupSource count
Extension Study: 9- to 15-Year-Old Females388
Extension Study: 9- to 15-Year-Old Males173
Values in milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females403.0Not reported357.3454.5Not reported
Extension Study: 9- to 15-Year-Old Males414.3Not reported353.8485.3Not 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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females128.1Not reported116.7140.7Not reported
Extension Study: 9- to 15-Year-Old Males148.4Not reported130.2169.2Not 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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females108.9Not reported97.6121.6Not reported
Extension Study: 9- to 15-Year-Old Males128.6Not reported111.2148.8Not 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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females59.2Not reported53.765.2Not reported
Extension Study: 9- to 15-Year-Old Males69.6Not reported60.779.7Not 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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females42.1Not reported37.747.1Not reported
Extension Study: 9- to 15-Year-Old Males49.8Not reported43.057.8Not 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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females55.3Not reported50.560.6Not reported
Extension Study: 9- to 15-Year-Old Males59.6Not reported52.068.4Not 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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extension Study: 9- to 15-Year-Old Females76.5Not reported69.284.6Not reported
Extension Study: 9- to 15-Year-Old Males90.5Not reported78.4104.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        111.1
        upper Limit
        134.7
        value
        122.3
      2. group Id
        OG001
        lower Limit
        112.5
        upper Limit
        149.1
        value
        129.5
    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
        72.5
        upper Limit
        88.8
        value
        80.2
      2. group Id
        OG001
        lower Limit
        78.4
        upper Limit
        105.6
        value
        91.0
    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
        357.3
        upper Limit
        454.5
        value
        403.0
      2. group Id
        OG001
        lower Limit
        353.8
        upper Limit
        485.3
        value
        414.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        388
      2. group Id
        OG001
        value
        173
      units
      Participants
    title
    Anti-HPV 16
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        116.7
        upper Limit
        140.7
        value
        128.1
      2. group Id
        OG001
        lower Limit
        130.2
        upper Limit
        169.2
        value
        148.4
    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
        97.6
        upper Limit
        121.6
        value
        108.9
      2. group Id
        OG001
        lower Limit
        111.2
        upper Limit
        148.8
        value
        128.6
    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
        53.7
        upper Limit
        65.2
        value
        59.2
      2. group Id
        OG001
        lower Limit
        60.7
        upper Limit
        79.7
        value
        69.6
    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
        37.7
        upper Limit
        47.1
        value
        42.1
      2. group Id
        OG001
        lower Limit
        43.0
        upper Limit
        57.8
        value
        49.8
    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
        50.5
        upper Limit
        60.6
        value
        55.3
      2. group Id
        OG001
        lower Limit
        52.0
        upper Limit
        68.4
        value
        59.6
    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
        69.2
        upper Limit
        84.6
        value
        76.5
      2. group Id
        OG001
        lower Limit
        78.4
        upper Limit
        104.6
        value
        90.5
    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 (milli Merck Units/mL) measured by cLIA to each of the 9vHPV types were assessed. 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
GEOMETRIC_MEAN
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: GMTs For Each of the HPV Types Contained in the Vaccine
type
PRIMARY
unit Of Measure
milli Merck Units/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice