Phase 3
N=362
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
Diphtheria · Tetanus · Pertussis · Hepatitis B · Haemophilus Influenzae Type b
Bottom Line
View on ClinicalTrials.gov: NCT00534833 ↗Enrolled (actual)
362
Serious AEs
5.8%
Results posted
Nov 2013
Primary outcome: Primary: Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV — 36; 58; 81; 94 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DTaP-HB-PRP~T vaccine (Biological); Tritanrix-HepB/Hib™ (Biological); Oral Polio Vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
36; 58; 81; 94; 82; 97 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
6.75; 17.5; 119; 1352; 0.908; 3.76 | — |
| SECONDARY Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
65; 124; 1; 9; 71; 90 | — |
Summary
The present trial is a follow-up of AL203 study (NCT00343889).
Primary Objectives:
To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine [OPV]).
Secondary Objective:
To describe the safety profile of a booster dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.
Eligibility Criteria
Inclusion Criteria
- Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive)
- Participated in the AL203 study and completed the three-dose primary series with either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age
- Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
- Able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received in the last 3 months
- Any vaccination in the 4 weeks preceding the trial vaccination
- Vaccination planned in the 4 weeks following the trial vaccination
- Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion
- History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically)
- Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B, or poliovirus 3 types antigen since the end of the primary series
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
- Serious adverse event related to any vaccination in the AL203 study.
Data sourced from ClinicalTrials.gov (NCT00534833). 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.