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- Title
The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule.
- Authors
Rusmil, Kusnandi; Gunardi, Hartono; Fadlyana, Eddy; Soedjatmiko; Dhamayanti, Meita; Sekartini, Rini; Satari, Hindra Irawan; Risan, Nelly Amalia; Prasetio, Dwi; Tarigan, Rodman; Garheni, Reni; Milanti, Mia; Hadinegoro, Sri Rezeki; Tanuwidjaja, Suganda; Bachtiar, Novilia Sjafri; Sari, Rini Mulia
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.<bold>Trial Registration: </bold>NCT01986335 - October 30(th) 2013.
- Subjects
HAEMOPHILUS influenzae; IMMUNOGENETICS; IMMUNIZATION; ADVERSE health care events; INFANT health; VACCINATION; CLINICAL trials; COMPARATIVE studies; DPT vaccines; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; MEDICAL protocols; RESEARCH; EVALUATION research; RANDOMIZED controlled trials; BLIND experiment; BACTERIAL capsules; ANTIBODY formation; DRUG administration; DRUG dosage
- Publication
BMC Pediatrics, 2015, Vol 15, p1
- ISSN
1471-2431
- Publication type
journal article
- DOI
10.1186/s12887-015-0525-2