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Primary Vaccination with a Diphtheria, Tetanus, Acellular Pertussis, Haemophilus Influenzae Type B Conjugate Vaccine (Pentaxim) at 6, 10 and 14 Weeks of Age of Infants in South Africa

Year: 2008
Type: article
Study design: Clinical Trial
Abstract: Background: There are few data on the immunogenicity and safety of acellular pertussis-based combination vaccines when given in the recommended WHO EPI schedule at 6, 10 and 14 weeks of age. Methods: A series of 212 infants in South Africa were sequentially enrolled, to receive a pentavalent combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b conjugate (PRP-T) antigens (Pentaxim™, Sanofi Pasteur, AcXim family vaccine) concomitantly with a monovalent hepatitis B vaccine (Heberbiovac HB™) at 6, 10 and 14 weeks of age. Antibody titers were measured immediately before and one month after the three-dose primary vaccination. Immunogenicity results obtained in French children vaccinated at 2, 3, 4 months of age, were used as a reference. Reactogenicity and safety were evaluated from parent reports. Results: After three doses of vaccine, the anti-PRP GMT was 2.01 μg/mL, anti-polio GMTs were 1453, 1699, and 2398 (1/dil U) for types 1, 2, and 3, respectively. Anti-PT and ant-FHA GMTs increased pre- to post-vaccination from 7.0 to 383 EU/mL, and from 9.6 to 161 EU/mL, respectively and all subjects had anti- PT and -FHA antibody titers ≥25 EU/mL. Two-fold increase in antibody concentration pre- to post-vaccination was 99.0% and 94.6%, for PT and FHA respectively. Anti-HBs GMT was 929 mIU/mL and all children had anti-HBs ≥10 mIU/mL. Vaccine reactogenicity was low, most reactions being mild or moderate, and there were no drop outs due to adverse events. Rates of severe solicited local adverse reactions (pain, redness and swelling) were ≤0.6%, and severe systemic solicited adverse events were from 0.5 to 1.3%, after any given dose of either vaccine. No hypotonic hyporesponsive episodes were reported. Conclusion: The immunogenicity of Pentaxim given at 6, 10 and 14 weeks of age was high in South African infants, similar to the findings of an earlier French trial, and a trial in children in the Philippines using same 6, 10, 14 wk EPI schedule.(1) Concurrent Hepatitis B vaccine produced a strong immune response. The combined vaccine and the hepatitis B vaccine were both well tolerated. [NCT 00254969]. (1) Capeding MR, Cadorna-Carlos J, Book-Montellano M, Ortiz E. Immunogenicity and safety of a DTaP-IPV//PRP∼T combination vaccine at 6, 10, 14 weeks of age (EPI schedule) and concomitant Hepatitis B vaccination at birth, 6, 14 or 6, 10, 14 weeks of age. Bull World Health Org 2008; in Press
DOI: 10.1016/j.ijid.2008.05.427
Language: English
Subfield: Microbiology
Open Access status: gold
Estimated APC paid: $2,900
OpenAlex ID: W2090618708
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