The objective of this study is to evaluate safety and tolerability of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed in Vietnamese infants aged 6-12 weeks. This is an open label, single group, bridging study.
This will be an open label, single group, bridging study. Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval. This study was performed in strict accordance with Good Clinical Practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
222
An openlabel, multicentric, bridging study to assess the safety of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine (Adsorbed) manufactured by Serum Institute of India Pvt. Ltd in Vietnamese infants aged 6-12 weeks, given as a 3-dose regime, with 4 week intervals between the doses
Hung Yen, Kim Dong
Hưng Yên, Vietnam
Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration
Time frame: Days 0 to 28 post-vaccination
Percent of Participants With Adverse Events Related to DTPw-HB-Hib vaccine Administration
Time frame: Baseline to 30 minutes post-vaccination
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