An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)

Phase 3

Completed

• Conditions: Papillomavirus Infections
• Interventions: Biological: Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®)

• Registration Number: NCT00496626
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Study Start: 2008-07-20
• Primary Completion: 2009-02-28
• Study Completion: 2009-02-28
• Results First Submitted: 2010-02-08
• Results First Submitted QC: 2010-06-08
• Results First Posted: 2010-07-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®)	V501 (Gardasil®)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7	Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination and Month 7	Anti-HPV 6, 11, 16, 18 Seroconversion Rate, i.e., the Number of participants who were seronegative at baseline and developed seropositive at Month 7. Seroconversion for HPV 6, 11, 16, and 18 is defined as achieving an anti-HPV cLIA level of at least 20, 16, 20 and 24 mMU/mL, respectively.; Seroconversion rate = (number of participants with seronegative at baseline and developed seropositive at Month 7)/(number of participants with seronegative at baseline regardless relevant HPV serum status at Month 7). Measure serum anti-HPV 6, 11, 16, 18 titers at Day 1 prior to vaccination and at Month 7
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	For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination	All adverse experiences were collected through 14 days following each vaccination. All participants were requested to record injection-site adverse experiences and monitor the participant's temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.