Phase 3
N=600
An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)
Papillomavirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00496626 ↗Enrolled (actual)
600
Serious AEs
0.2%
Results posted
Jul 2010
Primary outcome: Primary: Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines) — 7; 7; 426.0; 7 mMU/mL — p=<=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®) (Biological); Comparator: Placebo (Biological)
- Age
- Pediatric, Adult · 9+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines) |
7; 7; 426.0; 7; 8; 8 | <=0.05 |
| SECONDARY Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7 |
269; 2; 279; 2; 277; 0 | <=0.05 |
| SECONDARY Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination |
153; 131 | — |
Summary
This is a China registration study. A randomized, double-blind, placebo-controlled immunogenicity and safety study in Chinese female participants aged 9 to 45 years and male participants aged 9 to 15 years. Approximately 600 participants will be randomized in a 1:1 ratio to receive either vaccine or aluminum-containing placebo. Each participant received one injection at each visit at Day 1, Month 2, and Month 6. Vaccine or placebo was given as a 0.5-mL intramuscular injection. Serum will be collected from all participants to evaluate immune response against anti-Human Papillomavirus (HPV) 6/11/16/18 with Luminex Assay. At Month 2, Month 6, Month 7, subjects will be evaluated for any new medical condition or health concerns and Serious Adverse Experiences throughout the study. The primary objective is to evaluate the vaccine-induced serum anti-HPV 6, 11, 16 and 18 antibody titers following 3-dose regimen of Gardasil® compared with placebo.
Eligibility Criteria
Inclusion Criteria
- Healthy female participants aged 9-45 years old and male participants aged 9-15 years old
- Participants agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes
- Not pregnant now (as demonstrated by a negative urine beta-Human Chorionic Gonadotropin (beta-HCG) test) for post-pubertal female participants
Data sourced from ClinicalTrials.gov (NCT00496626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.