Phase 3 N=3,055 Randomized Double-blind Prevention

Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)

Cervical Cancer · Genital Warts

Bottom Line

View on ClinicalTrials.gov: NCT00092495 ↗

Enrolled (actual)

3,055

Serious AEs

0.4%

Results posted

Mar 2010

Primary outcome: Primary: Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 — 423; 428; 320; 0 Subjects — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine (Biological)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Sep 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3	372; 391; 363; 743; 0; 0	<0.001 sig
PRIMARY Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3	584.2; 704.5; 707.5; 798.4	<0.001 sig
PRIMARY Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3	373; 391; 364; 743; 0; 0	<0.001 sig
PRIMARY Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3	632.1; 804.7; 836.2; 1003.2	<0.001 sig
PRIMARY Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3	365; 375; 364; 730; 0; 0	<0.01 sig
PRIMARY Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3	2401.1; 2963.3; 3105.3; 3824.6	<0.001 sig
PRIMARY Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3	365; 375; 364; 730; 0; 0	<0.01 sig
PRIMARY Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3	381; 403; 375; 763; 1; 3	<0.001 sig
PRIMARY Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3	544.0; 640.4; 647.5; 696.9	<0.001 sig

Summary

The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.

Eligibility Criteria

Inclusion Criteria

Healthy adolescents and pre-adolescents with no prior sexual history
Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria

Prior Human Papillomavirus (HPV) vaccination
Prior abnormal Paps
Prior history of genital warts

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00092495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.