1. The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule
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Novilia Sjafri Bachtiar, Hartono Gunardi, Meita Dhamayanti, Rodman Tarigan, Reni Garheni, Hindra Irawan Satari, Suganda Tanuwidjaja, Dwi Prasetio, Sri Rezeki Hadinegoro, Nelly Amalia Risan, Rini Mulia Sari, Rini Sekartini, Kusnandi Rusmil, Mia Milanti, Eddy Fadlyana, and Soedjatmiko
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Male ,Pediatrics ,medicine.medical_specialty ,Hepatitis B vaccine ,complex mixtures ,Double-Blind Method ,medicine ,Humans ,Prospective Studies ,Pediatrics, Perinatology, and Child Health ,Prospective cohort study ,Adverse effect ,Bacterial Capsules ,Diphtheria-Tetanus-Pertussis Vaccine ,Immunization Schedule ,Haemophilus Vaccines ,business.industry ,Immunogenicity ,Infant ,Vaccination ,EPI ,Hib vaccine ,Immunization ,Antibody Formation ,Pediatrics, Perinatology and Child Health ,Pertussis vaccine ,Female ,Combined DTP-HB-Hib vaccine ,business ,Infants ,Primary vaccination ,Research Article ,medicine.drug - Abstract
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-tetanus-pertussis-Hepatitis B-Haemophilus influenza B) vaccine. 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. 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. 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. NCT01986335 – October 30th 2013.
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