Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

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)

Outcome Description:

Measured GMT of anti-HPV 6, 11, 16 and 18 at Day 1 and Month 7 (1 month after completion of administration of a 6-month 3-dose regimen of vaccines). GMT at Day 1 was used to define per-protocol population. Antibody titers were tested with Luminex array. The numeric values for the Day 1 (Vaccine and Placebo groups) and the Month 7 (Placebo groups) are the threshold of detection for the Luminex array assays. The reported values are all below the lower limit of qualification, ((less than) <7, <8, <11, <10 respectively)

Outcome Time Frame:

Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination, and Month 7

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

China: Food and Drug Administration

Study ID:

V501-030

NCT ID:

NCT00496626

Start Date:

July 2008

Completion Date:

February 2009

Related Keywords:

• Papillomavirus Infections
• HPV infections
• Papillomavirus Infections