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
Phase 2
10 Years
18 Years
10 Years
18 Years
Not Enrolling
Male
Prophylaxis HPV Infection
Male
Prophylaxis HPV Infection
Trial Information
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
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Outcome Measure:
Demonstration of immunogenicity of HPV vaccine in males.
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Finland: Ethics Committee
Study ID:
580299/011
NCT ID:
NCT00309166
Start Date:
April 2006
Completion Date:
Related Keywords:
- Prophylaxis HPV Infection
Name | Location |
|---|
