MedTrace Logo

V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)

NCT00411749 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2017-04-21

Study results available
· View outcomes & findings →

Summary

The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females

Conditions

  • HPV Infections

Interventions

BIOLOGICAL

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)

V501; Gardasil, 0.5 ml injection in 3 dosing regimen

BIOLOGICAL

Comparator: Placebo (unspecified)

Placebo 0.5 ml injection in 3 dosing regimen

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-11
Primary Completion
2009-09-18
Completion
2009-09-18

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00411749 on ClinicalTrials.gov