Phase 3
N=798
Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
Whole Cell Pertussis · Tetanus · Hepatitis B · Diphtheria · Haemophilus Influenzae Type b
Bottom Line
View on ClinicalTrials.gov: NCT00228917 ↗Enrolled (actual)
798
Serious AEs
0.8%
Results posted
Mar 2017
Primary outcome: Primary: Number of Subjects With Fever >39°C (Rectal Route). — 22; 8; 5; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tritanrix-HepB/Hib-MenAC (Biological); Tritanrix-HepB/Hiberix (Biological); Mencevax-ACWY (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Fever >39°C (Rectal Route). |
22; 8; 5; 3; 40; 24 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C |
113; 63; 41; 17; 53; 33 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms. |
168; 78; 55; 26; 151; 69 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs). |
64; 23; 24; 9; 53; 33 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs). |
3; 0; 0; 0; 2; 1 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00228917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.