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V501 Immunogenicity in Females 9-17 Years
NCT00411749Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2006
- Primary completion
- Sep 2009
- Sponsor
- Merck & Co.
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- human papillomavirus infection
01
Overview
Phase 2, randomised, double-blind trial of recombinant human papillomavirus 9-valent vaccine in human papillomavirus infection (2 arms), sponsored by Merck & Co. Primary endpoints: Human Papilloma Virus (HPV) 6 Serum Antibody Titer at Month 7, Human Papilloma Virus (HPV) 11 Serum Antibody Titer at Month 7 and 2 more. Started Dec 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
V501
Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Vaccine
Placebo
Placebo vaccination
03
Endpoints
Primary
Human Papilloma Virus (HPV) 6 Serum Antibody Titer
Human Papilloma Virus (HPV) 11 Serum Antibody Titer
Human Papilloma Virus (HPV) 16 Serum Antibody Titer
Human Papilloma Virus (HPV) 18 Serum Antibody Titer
Secondary
HPV 6, 11, 16 and 18 Serum Antibody Titer
04
Results
Primary endpoints met
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