Hepatitis B Clinical Trial
Official title:
An Open Label, 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
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.
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