Last updated: 11/03/2018 00:58:40
Lot-to-lot consistency of Tritanrix™-HepB/Hib-MenAC & its non-inferiority vs Tritanrix™-HepB/Hiberix™ in infants
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Demonstrate lot-to-lot consistency of final production method of GSK Biologicals' Hib-MenAC vaccine mixed extemporaneously with Tritanrix™-HepB & demonstrate its non-inferiority vs Tritanrix™-HepB/Hiberix™ in healthy infants at 2, 4 and 6 months
Trial description: The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals’ Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single injection.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
800
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Tetanus, Hepatitis B, Haemophilus influenzae type b, Whole Cell Pertussis, Diphtheria
Product
SB759346
Collaborators
Not applicable
Study date(s)
February 2006 to November 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
56 - 83 days
Accepts healthy volunteers
Yes
- healthy male or female, between, and including, 56 and 83 days of age.
- Born after a gestation period between 36 and 42 weeks
- planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period.
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
Inclusion and exclusion criteria
Inclusion criteria:
- healthy male or female, between, and including, 56 and 83 days of age.
- Born after a gestation period between 36 and 42 weeks
- Birth dose of hepatitis B vaccine within the first 72 hours of life
Exclusion criteria:
- planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period.
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- History of OR previous vaccination against OR known exposure since birth to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal 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)
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
2006-02-11
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.
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