Abstract | OBJECTIVE: METHODS: Infants were randomized to receive Hexavac (n = 423) or Pentavac and H-B-Vax II (n = 425) as a primary immunization series at 2, 4 and 6 months of age. Seroprotection and seroconversion rates against all antigens at 1 month after the primary series were compared between the two vaccine groups with 95% confidence intervals (CI0.95) and were considered clinically equivalent (not inferior) when the upper limit of the 95% confidence interval on the difference (reference, hexavalent) was below predefined differences. RESULTS:
Hexavac met and surpassed the pre-defined criteria for clinical equivalence to Pentavac and H-B-Vax II given concomitantly. It elicited similar seroprotection and seroconversion rates against all antigens. Seroprotection and seroconversion rates obtained 1 month after the third dose of Hexavac were >90% for all antigens. The postimmunization antibody geometric mean titers (GMT) for hepatitis B and purified Haemophilus influenzae polysaccharide were about 2-fold higher in infants who received the reference vaccines than in infants who had received Hexavac. GMTs for poliovirus antibodies tended to be enhanced in infants vaccinated with Hexavac. GMTs for all other antigens were very similar among both groups. Hexavac was generally well-tolerated. At least one local reaction was reported in 20.3% of Hexavac injections compared with 15.8% at the Pentavac injections site and 3.8% at the H-B-Vax II injections site. These reactions were generally mild and transient. At least one systemic adverse event was reported in 45.7% of Hexavac injections compared with 42.2% of Pentavac and H-B-Vax II injections (mild fever, irritability and drowsiness were most frequently reported). The frequency of adverse events was not significantly different between groups. No vaccine-related serious adverse event occurred during the study. CONCLUSION: This liquid hexavalent vaccine was generally well-tolerated and provided immune responses adequate to be protective against six infectious diseases with a single injection, given at 2, 4 and 6 months of age.
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Authors | E Mallet, P Fabre, E Pines, H Salomon, T Staub, F Schödel, P Mendelman, L Hessel, G Chryssomalis, E Vidor, A Hoffenbach, Hexavalent Vaccine Trial Study Group |
Journal | The Pediatric infectious disease journal
(Pediatr Infect Dis J)
Vol. 19
Issue 12
Pg. 1119-27
(Dec 2000)
ISSN: 0891-3668 [Print] United States |
PMID | 11144370
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Bacterial
- Antibodies, Viral
- Diphtheria-Tetanus-Pertussis Vaccine
- Diphtheria-Tetanus-acellular Pertussis Vaccines
- Haemophilus Vaccines
- Hepatitis B Vaccines
- Hexavac
- Pentavac
- Poliovirus Vaccine, Inactivated
- Vaccines, Combined
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Topics |
- Antibodies, Bacterial
(blood)
- Antibodies, Viral
(blood)
- Diphtheria-Tetanus-Pertussis Vaccine
- Diphtheria-Tetanus-acellular Pertussis Vaccines
(administration & dosage, adverse effects, immunology)
- Female
- Haemophilus Vaccines
(administration & dosage, adverse effects, immunology)
- Hepatitis B Vaccines
(administration & dosage, adverse effects, immunology)
- Humans
- Immunization Schedule
- Infant
- Male
- Poliovirus Vaccine, Inactivated
(administration & dosage, adverse effects, immunology)
- Prospective Studies
- Vaccines, Combined
(administration & dosage, adverse effects, immunology)
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