[HTML][HTML] The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule
BMC pediatrics, 2015•Springer
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-tetanus-pertussis-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 …
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. Methods A prospective, randomized, double blind,
multicenter, phase III study of Bio Farma DTP-HB-Hib vaccine conducted in Jakarta and …
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-tetanus-pertussis-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.
Trial registration
NCT01986335 – October 30th 2013.
Springer
以上显示的是最相近的搜索结果。 查看全部搜索结果