The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule

Kusnandi Rusmil, Hartono Gunardi, Eddy Fadlyana, Soedjatmiko, Meita Dhamayanti, Rini Sekartini, Hindra Irawan Satari, Nelly Amalia Risan, Dwi Prasetio, Rodman Tarigan, Reni Garheni, Mia Milanti, Sri Rezeki S. Harun Hadinegoro, Suganda Tanuwidjaja, Novilia Sjafri Bachtiar, Rini Mulia Sari

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5 Citations (Scopus)

Abstract

Background: WHO recommended incorporation of Haemophilus influenzae type b (Hib) vaccination into immunization program. Indonesia would adopt Hib as a National Immunization Program in 2013. We aimed at analyzing immunogenicity, safety, and consistency of a new combined DTP-HB-Hib (diphtheria-tetanuspertussis- Hepatitis B-Haemophilus influenza B) vaccine. Methods: A prospective, randomized, double blind, multicenter, phase III study of Bio Farma DTP-HB-Hib vaccine conducted in Jakarta and Bandung, August 2012 - January 2013. Subjects were divided into three groups with different batch number. Healthy infants 6-11 weeks of age at enrollment were immunized with 3 doses of DTP-HB-Hib vaccine with interval of 4 weeks, after birth dose of hepatitis B vaccine. Blood samples obtained prior to vaccination and 28 days after the third dose. Safety measures recorded until 28 days after each dose. Results: Of 600 subjects, 575 (96 %) completed study protocol. After 3 doses, 100.0 and 96.0 % had anti-PRP concentration ≥0.15 and ≥1.0 μg/ml. Anti-diphtheria and anti-tetanus concentration ≥0.01 IU/ml detected in 99.7 and 100.0 %; while concentration ≥0.1 IU/ml achieved in 84.0 and 97.4 %. Protective anti-HBs found in 99.3 %. The pertussis vaccine response rate was 84.9 %. None Serious Adverse events (SAEs) considered related to study vaccine or procedure. Conclusions: The 3-dose of DTP-HB-Hib was immunogenic, well tolerated and suitable for replacement of licensed-equivalent vaccines based on immunologic and safety profiles.

Original languageEnglish
Article number219
JournalBMC Pediatrics
Volume15
Issue number1
DOIs
Publication statusPublished - 19 Dec 2015

Keywords

  • Combined DTP-HB-Hib vaccine
  • EPI
  • Infants
  • Primary vaccination

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