A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)

Cervical Cancer Clinical Trial

Official title:

A Randomized, Double-Blinded, Tolerability and Immunogenicity Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered Concomitantly With GARDASIL to 16- to 26- Year-Old Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551187
• Other study ID #: V504-001
• Secondary ID: 2007_566
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2007
• Last updated: June 5, 2015
• Start date: October 2007
• Est. completion date: May 2009

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 26 Years

Eligibility

Inclusion Criteria:

• Females between 16- to 26-years-old

• Has never had Pap testing or has 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 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 the 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:
• V504
V504 0.5 ml injection in 3 dose regimen for 6 month treatment period.
• Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.
• Comparator: Placebo (unspecified)
V504 Placebo in 3 dose regimen for 6 month treatment period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Luxembourg A, Brown D, Bouchard C, Giuliano AR, Iversen OE, Joura EA, Penny ME, Restrepo JA, Romaguera J, Maansson R, Moeller E, Ritter M, Chen J. Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine. Hum Vaccin Immunother. 2015;11(6):1313-22. doi: 10.1080/21645515.2015.1012010. — View Citation

Outcome

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