Last updated: 11/07/2018 00:16:55
Primary & booster immunogenicity study of GSK Biologicals’ Hib-MenC versus a licensed Men-C vaccine
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months
Trial description: The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15 months of age.
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:
Pace D et al. (2007) A new combination haemophilus influenzae type B and Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine for primary immunization of infants. Pediatr Infect Dis J. 26 (11): 1057-1059.
Medical condition
Haemophilus influenzae type b, Neisseria Meningitidis
Product
SB811936
Collaborators
Not applicable
Study date(s)
February 2005 to September 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- Inclusion criteria:
- Healthy male or female, between, and including, 6 and 12 weeks of age.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Healthy male or female, between, and including, 6 and 12 weeks of age.
- Born after a gestation period between 36 and 42 weeks
- Vaccination with hepatitis B at birth and at 6 to 12 weeks (concomitantly with the first study vaccine), accepted although not mandatory Exclusion criteria:
- Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with the exception of Bacille Calmette Guerin (BCG) and hepatitis B vaccines.
- History of H. influenzae type b and /or meningococcal serogroup C disease.
- Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio or Hib disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- A family history of congenital or hereditary immunodeficiency
- History of any neurologic disorders or seizures
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Trial location(s)
Showing 1 - 6 of 10 Results
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
2005-05-09
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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