Status:
COMPLETED
Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
MALE
10-18 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 5 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2007
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00309166
Start Date
April 5 2006
End Date
June 19 2007
Last Update
September 17 2018
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Kotka, Finland, 48100
2
GSK Investigational Site
Kouvola, Finland, 45100
3
GSK Investigational Site
Mikkeli, Finland, 50100
4
GSK Investigational Site
Rauma, Finland, 26100