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

NCT00551187 — Phase 2, Completed, 620 participants, Merck Sharp & Dohme LLC

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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

Registry	NCT00551187
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	620 (Actual)
Sponsor	Merck Sharp & Dohme LLC (Industry)
Conditions	Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection
Interventions	V504, Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Comparator: Placebo (unspecified) (Biological)
Dates	start 2007-10-01, primary completion 2009-05-01, completion 2009-05-01, first posted 2007-10-30, last updated 2015-06-08

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Biological: V504; Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine	V504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
2	Placebo comparator	Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine; Biological: Comparator: Placebo (unspecified)	Placebo + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

V504 (Biological): 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 (Biological): 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) (Biological): V504 Placebo in 3 dose regimen for 6 month treatment period.

+Outcome measures

Primary outcomes

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

Secondary outcomes

Seroconversion percentages to HPV types contained in the administered vaccines [4 weeks post dose 3]

+Eligibility

Sex: Female, ages: 16 Years to 26 Years, accepts healthy volunteers

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)

+Publications

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. PMID 25912208

+Investigators

Medical Monitor, Study director, Merck Sharp & Dohme LLC