Clinical trial

Study of an Investigational Vaccine in Pre-Adolescents and Adolescents…

NCT00092495 · Merck Sharp & Dohme LLC, Industry · Completed

Key facts

NCT number NCT00092495
Title Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
Official title A Study to Demonstrate Immunogenicity and Tolerability of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents, and To Determine End-Expiry Specifications for the Vaccine
Lead sponsor Merck Sharp & Dohme LLC, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Cervical Cancer, Genital Warts
Intervention type Biological
Interventions V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
Enrollment 3,055
Start date Dec 1, 2002
Primary completion Sep 1, 2004
Completion Feb 1, 2009
First posted Sep 27, 2004
Last update posted Jan 13, 2015

At a glance

  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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