TY - JOUR
T1 - The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule
AU - Rusmil, Kusnandi
AU - Gunardi, Hartono
AU - Fadlyana, Eddy
AU - Soedjatmiko, null
AU - Dhamayanti, Meita
AU - Sekartini, Rini
AU - Satari, Hindra Irawan
AU - Risan, Nelly Amalia
AU - Prasetio, Dwi
AU - Tarigan, Rodman
AU - Garheni, Reni
AU - Milanti, Mia
AU - Hadinegoro, Sri Rezeki S. Harun
AU - Tanuwidjaja, Suganda
AU - Bachtiar, Novilia Sjafri
AU - Sari, Rini Mulia
N1 - Publisher Copyright:
© 2015 Rusmil et al.
PY - 2015/12/19
Y1 - 2015/12/19
N2 - 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.
AB - 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.
KW - Combined DTP-HB-Hib vaccine
KW - EPI
KW - Infants
KW - Primary vaccination
UR - http://www.scopus.com/inward/record.url?scp=84951136426&partnerID=8YFLogxK
U2 - 10.1186/s12887-015-0525-2
DO - 10.1186/s12887-015-0525-2
M3 - Article
C2 - 26686508
AN - SCOPUS:84951136426
SN - 1471-2431
VL - 15
JO - BMC Pediatrics
JF - BMC Pediatrics
IS - 1
M1 - 219
ER -
