Last updated: 11/07/2018 15:11:24
Immunogenicity & safety study of a meningococcal serogroup B vaccine given in a 3 dose schedule to healthy adolescents aged 12-18 yrs
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A primary vaccination study to evaluate immunogenicity, safety and reactogenicity of 3 doses of GSK Biologicals/Finlay’s meningococcal B candidate vaccine given intramuscularly using either 0-2-4 month or 0-1-6 month schedule to healthy subjects aged 12-18 years
Trial description: The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of Havrix™ (0-6 months) and Meningitec™ (month 1).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
478
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Boutriau D et al. (2007)Immunogenicity and safety of three doses of a bivalent (B:4:p1.19,15 and B:4:p1.7-2,4) meningococcal outer membrane vesicle vaccine in healthy adolescents. Clin Vaccine Immunol. 14 (1):65-73.
Medical condition
Infections, Meningococcal
Product
Meningococcal Vaccine
Collaborators
Not applicable
Study date(s)
July 2002 to June 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
12 - 18 years
Accepts healthy volunteers
Yes
- Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination.
- Female subjects must be of non-childbearing potential.
- Previous vaccination against or history of meningococcal B or C, or hepatitis A disease or exposure to meningococcal B disease within last year.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination.
- Female subjects must be of non-childbearing potential.
Exclusion criteria:
- Previous vaccination against or history of meningococcal B or C, or hepatitis A disease or exposure to meningococcal B disease within last year.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- History of any neurologic disorders or seizures.
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-30-06
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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