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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00309166
First Posted: March 31, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
March 28, 2006
March 31, 2006
October 12, 2017
April 2006
June 2007   (Final data collection date for primary outcome measure)
Demonstration of immunogenicity of HPV vaccine in males.
Same as current
Complete list of historical versions of study NCT00309166 on ClinicalTrials.gov Archive Site
Evaluation of safety and reactogenicity throughout the entire study.
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Infections, Papillomavirus
Biological: HPV vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
June 2007
June 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
10 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT00309166
580299/011
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP