At a glance
ClinicalIndex Comparison Record- ✓Male aged 10–18 years at first vaccination
- ✓Healthy status confirmed by medical history and clinical examination
- ✕Prior HPV vaccination
- ✕Prior Hepatitis B vaccination or clinical history of Hepatitis B infection
- ✕Cancer or autoimmune disease under treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Cervarix vaccine and Engerix-B vaccine for Infections, Papillomavirus. Completed, enrolled 270 participants across 5 sites.
Detailed 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 Details
Timeline
Interventions
All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.
All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule