drugset / Trial / NCT03931239

The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks

NCT03931239 ↗

NaSingle-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2018-03-01
Primary completion
2018-06-30
Completion
2018-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject DTPw-HB-Hib vaccine Vaccine — Intramuscular