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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520598
• Other study ID #: V505-001
• Secondary ID: 2007_567
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2007
• Last updated: November 25, 2015
• Start date: October 2007
• Est. completion date: May 2011

Study information

• Verified date: November 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 26 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• Genital Warts
• Human Papillomavirus Infection
• Papillomavirus Infections
• Uterine Cervical Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

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.

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.
• Comparator: V505 formulation 2
0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.

Biological:
• Comparator: V505 formulation 3
0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.
• 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.
• Comparator: Placebo (unspecified)
0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen		4 weeks post dose 3	No
Secondary	Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen		4 weeks post dose 2	No