Trial intelligence / Profile preview

Safety and Immunogenicity of Gardasil Co-administered with REPEVAX in Adolescents

NCT00337428Phase 3

Key facts

Status: Completed
Start: May 2006
Primary completion: May 2007
Sponsor: Merck & Co.
Modality: Vaccines & Immunotherapeutics

Drugs: recombinant human papillomavirus 9-valent vaccine
Conditions: human papillomavirus infection

Overview

Phase 3, randomised, open-label trial of recombinant human papillomavirus 9-valent vaccine in human papillomavirus infection (4 arms), sponsored by Merck & Co. Primary endpoints: Geometric Mean Titers for Anti-HPV 6 at Month 7, Geometric Mean Titers for Anti-HPV 11 at Month 7 and 15 more. Started May 2006; status: completed.

Design

4 arms

Study design: RandomizedOpen-label

Concomitant/CMF
Gardasil (CMF) + REPEVAX at Day 1
Non-Concomitant/CMF
Gardasil (CMF) at Day 1, REPEVAX at Month 1
Concomitant/FMF
Gardasil (FMF) + REPEVAX at Day 1
Non-Concomitant/FMF
Gardasil (FMF) at Day 1, REPEVAX at Month 1

Who it enrols

Healthy boys and girls 11-17 years of age who are virgins and have been previously vaccinated against DTP and polio (but not within the last 5 years).

Endpoints

Primary

Geometric Mean Titers for Anti-HPV 6Month 7
Geometric Mean Titers for Anti-HPV 11Month 7
Geometric Mean Titers for Anti-HPV 16Month 7
Geometric Mean Titers for Anti-HPV 18Month 7
Seroconversion for HPV Type 6Month 7

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