Last updated: 02/17/2020 13:50:04
Safety study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
GSK study ID
103812
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Assess reactogenicity & safety of a booster of either Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix given (single-blind) at 15-18 (Philippines)/15-24 mths (Thailand) & a dose of Mencevax ACWY at 24-30 mths (open label)
Trial description: This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child. In the Mencevax ACWY phase at 24-30 months, a dose of Mencevax ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix-HepB/Hib-MenAC. No blood samples will be taken in this safety study.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Number of subjects with fever >39°C (rectal route).
Timeframe: During the 4-day (Day 0-3) follow-up period after booster vaccination
Secondary outcomes:
Number of subjects with any, Grade 3 and related solicited general symptoms, other than fever > 39.0°C
Timeframe: During the 4-day (Day 0-3) follow-up period after vaccination
Number of subjects with any and Grade 3 solicited local symptoms.
Timeframe: During the 4-day (Day 0-3) follow-up period after booster vaccination
Number of subjects with any unsolicited adverse events (AEs).
Timeframe: During the 31-day (Day 0-30) following booster vaccination
Number of subjects with serious adverse events (SAEs).
Timeframe: From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination
Interventions:
Enrollment:
798
Primary completion date:
2006-20-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Whole Cell Pertussis, Tetanus, Hepatitis B, Diphtheria, Haemophilus influenzae type b, Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenzae type b-Neisseria Meningitidis Vaccin
Product
SB759346
Collaborators
Not applicable
Study date(s)
June 2005 to January 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
427 - 577 days
Accepts healthy volunteers
Yes
- Written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (Philippines)/ 15 and 24 months age (Thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
- Chronic administration (> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (Philippines)/ 15 and 24 months age (Thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
- Chronic administration (> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral poliovirus vaccine can be given concomitantly.
- Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2006-20-01
Actual study completion date
2006-20-01
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
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