Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00520598
• Collaborator: (none)
• Enrollment: 511
• Arms: 5
• Duration (Months): 43

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection	Biological: Comparator: V505 formulation 1; Drug: Comparator: V505 formulation 2; Drug: Comparator: V505 formulation 2; Biological: Comparator: V505 formulation 3; Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant; Biological: Comparator: Placebo (unspecified)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 511 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.	Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant; 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.
Experimental: 2 Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.	Biological: Comparator: V505 formulation 1; 0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
Experimental: 3 Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen	Drug: Comparator: V505 formulation 2; 0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
Experimental: 4 Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection	Drug: Comparator: V505 formulation 2; 0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.; Biological: Comparator: Placebo (unspecified); 0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
Experimental: 5 Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection	Biological: Comparator: V505 formulation 3; 0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.; Biological: Comparator: Placebo (unspecified); 0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.

Outcome Measures

Primary Outcome Measures

1. Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen [4 weeks post dose 3]

Secondary Outcome Measures

1. Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen [4 weeks post dose 2]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 26 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Female between 16 to 26 years old

• Has never had Pap testing or have only had normal Pap test results

• Lifetime history of 0 to 4 sexual partners

Exclusion Criteria:

• History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser

• History of severe allergic reaction that required medical attention

• Are pregnant

• Received a marketed HPV vaccine

• Currently enrolled in a clinical trial

• Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00520598
• Other Study ID Numbers: V505-001; 2007_567
• First Posted: Aug 24, 2007
• Last Update Posted: Nov 26, 2015
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Papillomavirus Infections; Condylomata Acuminata; Vulvar Neoplasms; Vaginal Neoplasms

Study Results

No Results Posted as of Nov 26, 2015