Last updated: 11/04/2018 03:57:46
Evaluation of the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine in young males.
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Number of seroconverted subjects for anti-HPV-16 and anti-HPV-18
Timeframe: At Month 7
Antibody titers against HPV-16 (anti-HPV-16) and HPV-18 (anti-HPV-18)
Timeframe: At Month 7
Secondary outcomes:
Number of seroconverted subjects for anti-HPV-16 and anti-HPV-18
Timeframe: At Month 2
Antibody titers against HPV-16 (anti-HPV-16) and HPV-18 (anti-HPV-18)
Timeframe: At Month 2
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
Timeframe: Within 30 days (Day 0-29) after any vaccination, up to 7 months
Number of subjects with new onset of chronic diseases (NOCDs) and other medically significant conditions
Timeframe: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
Number of subjects with serious adverse events (SAEs)
Timeframe: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
Number of subjects with clinically relevant abnormalities in biochemical and haematological parameters
Timeframe: At Month 2 and Month 7, post-vaccination
Number of subjects with clinically relevant abnormalities in biochemical and haematological parameters
Timeframe: At Month 2 and at Month 7, post-vaccination
Interventions:
Enrollment:
270
Primary completion date:
2007-19-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Petäjä T et al. (2009) Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Vaccine in Healthy Boys Aged 10–18 Years. J Adolesc Health. 44(1): 33–40.
Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
Medical condition
Infections, Papillomavirus
Product
SB580299, SKF103860
Collaborators
Not applicable
Study date(s)
April 2006 to June 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Male
Age
10 - 18 years
Accepts healthy volunteers
Yes
- Inclusion criteria:
- A male between, and including, 10 and 18 years of age at the time of the first vaccination.
Inclusion and exclusion 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.
Inclusion criteria:
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2007-19-06
Actual study completion date
2007-19-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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