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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 270
- Locations
- 5
- Primary Endpoint
- Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •A male between, and including, 10 and 18 years of age at the time of the first vaccination.
- •Written informed consent obtained from the subject prior to enrolment
- •For subjects below the legal age of consent, a written informed consent must be obtained from the subject's parent/guardian. In addition, a written informed assent must be obtained from the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- •Previous vaccination against Human Papillomavirus (HPV).
- •Previous vaccination against Hepatitis B, known clinical history of Hepatitis B infection.
- •Cancer or autoimmune disease under treatment.
Arms & Interventions
Cervarix Group
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Intervention: Cervarix vaccine (Biological)
Engerix-B Group
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Intervention: Engerix-B vaccine (Biological)
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))
- Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters(At Month 2 and Month 7, post-vaccination)