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

Phase 3

Completed

• Conditions: Cervical Cancer; Genital Warts
• Interventions: Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

• Registration Number: NCT00092495
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2004-09
• Study First Submitted: 2004-09-22
• Study First Submitted QC: 2004-09-24
• Study First Posted: 2004-09-27
• Study Completion: 2009-02
• Results First Submitted: 2010-02-15
• Results First Submitted QC: 2010-02-15
• Results First Posted: 2010-03-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2015-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3055

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine	60% Formulation qHPV Vaccine
1	V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine	100% Formulation qHPV Vaccine
4	V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine	20% Formulation qHPV Vaccine
3	V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine	40% Formulation qHPV Vaccine

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3	Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3	Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3	Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3	Week 4 Postdose 3 (Month 7)	Seroconversion is defined as going from seronegative to seropositive.; Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3	Week 4 Postdose 3 (Month 7)	Seroconversion is defined as going from seronegative to seropositive.; Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3	Week 4 Postdose 3 (Month 7)	Seroconversion is defined as going from seronegative to seropositive.; Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3	Week 4 Postdose 3 (Month 7)	Seroconversion is defined as going from seronegative to seropositive.; Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).
Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3	Week 4 Postdose 3 (Month 7)