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Immunogenicity and safety of a heptavalent (diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae b, and meningococcal serogroup C) vaccine

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Summary

In this open, phase II, randomized study, 480 infants from Germany, France and Canada received the heptavalent vaccine (Hepta group) or hexavalent and monovalent meningococcal serogroup C control vaccines (HexaMenC group) co-administered with a 13-valent pneumococcal conjugate vaccine at 2, 4 and 12 months of age. Immunogenicity was measured 1 month after the second primary dose, and before and 1 month after the booster dose. Non-inferiority of immune responses to meningococcal serogroup C (MenC) and Haemophilus influenzae b (Hib) induced by 2-dose primary vaccination with the heptavalent vaccine versus control vaccines was demonstrated. In exploratory analyses, post-primary and post-booster functional antibody geometric mean titers against MenC tended to be lower (1119.5 vs 3200.5; 2653.8 vs 6028.4) and antibody geometric mean concentrations against Hib higher (1.594 vs 0.671 μg/mL; 17.678 vs 13.737 μg/mL) in the Hepta versus the HexaMenC group. The heptavalent and control vaccines were immunogenic to all other antigens, although immune responses to poliovirus were lower than expected in both groups. No differences in safety and reactogenicity profiles were detected between groups.

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Authors and Affiliations

  1. Department of Pediatrics, PGIMER, Chandigarh, India

    Joseph L. Mathew

  2. Department of Community Medicine, AIIMS, New Delhi, India

    Sumit Malhotra

  3. School of Medical Sciences and Research, Sharda University, Greater Noida, UP, India

    A. K. Dutta

Authors
  1. Joseph L. Mathew
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  2. Sumit Malhotra
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  3. A. K. Dutta
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Correspondence to Joseph L. Mathew.

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Mathew, J.L., Malhotra, S. & Dutta, A.K. Immunogenicity and safety of a heptavalent (diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae b, and meningococcal serogroup C) vaccine. Indian Pediatr 52, 144–148 (2015). https://doi.org/10.1007/s13312-015-0590-5

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  • DOI: https://doi.org/10.1007/s13312-015-0590-5

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