V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)

Phase 2CompletedNCT00411749

Merck Sharp & Dohme LLC107 enrolled

Overview

The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

107

Conditions

HPV Infections

Interventions

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)BIOLOGICAL

V501; Gardasil, 0.5 ml injection in 3 dosing regimen

Comparator: Placebo (unspecified)BIOLOGICAL

Placebo 0.5 ml injection in 3 dosing regimen

Eligibility

Sex: FEMALEMin age: 9 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Virginal Female Subject Aged 9 To 17 Years Exclusion Criteria: * Male Subject

Outcomes

Primary Outcomes

Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series

Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) by vaccine group. The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".

Time frame: At one month after completed vaccination series (Month 7)

Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series

Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".

Time frame: At one month after completed vaccination series (Month 7)

Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series

Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".

Time frame: At one month after completed vaccination series (Month 7)

Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series

Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".

Time frame: At one month after completed vaccination series (Month 7)

Secondary Outcomes

HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series

Month 30 HPV cLIA Geometric Mean Titers by vaccine group.

Time frame: 24 month after completed vaccination series (Month 30)

Data from ClinicalTrials.gov

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