NCT00309166

Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 10 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	Cervarix vaccine	All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.
BIOLOGICAL	Engerix-B vaccine	All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule

Timeline

• Start date: 2006-04-05
• Primary completion: 2007-06-01
• Completion: 2007-06-19
• First posted: 2006-03-31
• Last updated: 2018-09-17
• Results posted: 2018-09-17

Locations

5 sites across 1 country: Finland