Last updated: 11/02/2018 23:16:56
Safety study of a vaccine against meningitis in infants (2,4 & 6 months age) after a birth dose of hepatitis B.
GSK study ID
100791
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Partially blinded study to assess reactogenicity & safety of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ in healthy infants after a hepatitis B birth dose
Trial description: The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1
Timeframe: Days 0-3 post dose 1
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2
Timeframe: Days 0-3 post dose 2
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3
Timeframe: Days 0-3 post dose 3
Secondary outcomes:
Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose
Timeframe: Days 0-3 after each dose
Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose
Timeframe: Day 0-30 after each dose
Occurrence of serious adverse events during the entire study period
Timeframe: Day 0 up to Month 5
Interventions:
Enrollment:
500
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B, Diphtheria, Whole Cell Pertussis, Tetanus, Haemophilus influenzae type b
Product
SB759346
Collaborators
Not applicable
Study date(s)
June 2004 to January 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
56 - 83 days
Accepts healthy volunteers
Yes
- Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis B vaccine within the first 3 days of life.
- Any confirmed immunodeficient condition, based on medical history and physical examination.
- 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 with the exception of oral polio vaccine (OPV).
Inclusion and exclusion criteria
Inclusion criteria:
Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis B vaccine within the first 3 days 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 with the exception of oral polio vaccine (OPV).
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.
- History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Any confirmed immunodeficient condition, based on medical history and physical examination.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-16-01
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
Additional information
Not applicable
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