Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)

This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.

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Key information

Conditions

HPV Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Premalignancy Anogenital Warts Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

16 year–23 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

Lifetime history of 0-4 sexual partners

Exclusion criteria

History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test

Treatment and study plan

Comparator: Gardasil

Biological

0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6

Comparator: octavalent HPV Vaccine - dose formulation 1

Biological

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

Comparator: octavalent HPV Vaccine - dose formulation 2

Biological

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

Comparator: octavalent HPV Vaccine - dose formulation 3

Biological

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

Primary outcomes

The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay.

Time frame: 4 weeks post dose 3 injection

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Dec 1, 2005
Registry last updated: Jun 8, 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