An Observer-blind, Randomized, Controlled Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Male Subjects Aged 10-18 Years
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Infections, Papillomavirus
- Sponsor
- GlaxoSmithKline
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The main aim of this vaccine is to prevent cervical cancer in women. However, it could also be relevant to vaccinate selected groups of males. Therefore, this study is designed to evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male subjects aged 10-18 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Time Frame: At Month 7
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies \[anti-HPV-16 titers greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 titres ≥7 EL.U/mL\] in the serum of subjects seronegative before vaccination.
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Time Frame: At Month 7
Titers were presented as geometric mean titers (GMT).
Secondary Outcomes
- Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18(At Month 2)
- Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions(Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within 7 days (Days 0-6) after each dose and across doses, up to 7 months)
- Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters(At Month 2 and at Month 7, post-vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within 7 days (Days 0-6) after each dose and across doses, up to 7 months)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within 30 days (Day 0-29) after any vaccination, up to 7 months)
- Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)(At Month 2)
- Number of Subjects With Serious Adverse Events (SAEs)(Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12))