Last updated: 11/04/2018 04:09:51
Safety study of a vaccine against meningitis in infants ( 2,4 & 6 months age) after a birth dose of hepatitis B.
GSK study ID
759346/004
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Assess reactogenicity and safety of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC compared to Tritanrix™-HepB/Hiberix™ (control) in healthy infants (2,4,6 months age), 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
Diphtheria, Hepatitis B, Whole Cell Pertussis, Haemophilus influenzae type b, Tetanus
Product
SB759346
Collaborators
Not applicable
Study date(s)
December 2003 to October 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
Not applicable - 3 days
Accepts healthy volunteers
Yes
- Inclusion criteria at study entry:
- Healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria at study entry:
- Healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. Exclusion criteria at study entry:
- Any confirmed immunodeficient condition, based on medical history & physical examination.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute disease at the time of enrolment.
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
2004-23-10
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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