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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


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
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