Broad Spectrum HPV (Human Papillomaviru… | Clinical Trial

Key information

Conditions

Cervical Cancer Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Genital Warts Human Papillomavirus Infection Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Virus Diseases Vulvar Cancer Vulvar Diseases Vulvar Neoplasms Warts

Age range

16 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Comparator: V505 formulation 1

Biological

0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.

Comparator: V505 formulation 2

Drug

0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.

Comparator: V505 formulation 3

Biological

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

Biological

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)

Biological

0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.

Primary outcomes

Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen

Time frame: 4 weeks post dose 3

Secondary outcomes

Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen

Time frame: 4 weeks post dose 2

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Aug 24, 2007
Registry last updated: Nov 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed