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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 28, 2006

Last Updated Date

October 16, 2008

Start Date ^†

April 2006

Current Primary Outcome Measures ^†

Demonstration of immunogenicity of HPV vaccine in males.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00309166 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Evaluation of safety and reactogenicity throughout the entire study.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Single Blind, Parallel Assignment

Condition ^†

Prophylaxis HPV Infection

Intervention ^†

Biological: HPV vaccine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

270

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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.

Gender

Male

Ages

10 Years to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Finland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00309166

Responsible Party

Study Director, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.