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

NCT ID: NCT00496626

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-20
• Study Completion Date: 2009-02-28

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.

Conditions

Papillomavirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

V501 (Gardasil®)

Group Type: EXPERIMENTAL

Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®)

Intervention Type: BIOLOGICAL

Human Papillomavirus (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6

2

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: BIOLOGICAL

aluminum-contained, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6

Interventions

Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®)

Human Papillomavirus (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6

Intervention Type: BIOLOGICAL

Comparator: Placebo

aluminum-contained, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6

Intervention Type: BIOLOGICAL

Other Intervention Names

V501; Gardasil®

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Li R, Li Y, Radley D, Liu Y, Huang T, Sings HL, Zhang L, Wang W, Zhong X, Saah AJ. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, double-blind, placebo-controlled trial in Chinese males and females. Vaccine. 2012 Jun 13;30(28):4284-91. doi: 10.1016/j.vaccine.2012.02.079. Epub 2012 Mar 18.

Reference Type: RESULT

PMID: 22433961 (View on PubMed)

Other Identifiers

2007_021

Identifier Type: -

Identifier Source: secondary_id

V501-030

Identifier Type: -

Identifier Source: org_study_id

NCT00926822

Identifier Type: -

Identifier Source: nct_alias