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

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ClinicalTrials.gov Identifier: NCT00309166
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Infections, Papillomavirus Biological: HPV vaccine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
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
Study Start Date : April 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007



Primary Outcome Measures :
  1. Demonstration of immunogenicity of HPV vaccine in males.

Secondary Outcome Measures :
  1. Evaluation of safety and reactogenicity throughout the entire study.


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309166


Locations
Finland
GSK Investigational Site
Kotka, Finland, 48100
GSK Investigational Site
Kouvola, Finland, 45100
GSK Investigational Site
Mikkeli, Finland, 50100
GSK Investigational Site
Rauma, Finland, 26100
GSK Investigational Site
Tampere, Finland, 33200
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 580299/011
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 580299/011
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 580299/011
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 580299/011
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 580299/011
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 580299/011
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00309166     History of Changes
Other Study ID Numbers: 580299/011
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
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.

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs