NCT03931239View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

March 1, 2018

Primary Completion Date

June 30, 2018

Study Completion Date

July 30, 2018

Conditions
DiphtheriaTetanusPertussisHepatitis BHaemophilus Influenzae Type B
Interventions
BIOLOGICAL

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

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

Trial Locations (1)

Unknown

Hung Yen, Kim Dong, Hưng Yên

Sponsors

Lead Sponsor

Vabiotech
All Listed Sponsors
collaborator

Vietstar Biomedical Research

INDUSTRY

lead

Vabiotech

INDUSTRY

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 | Biotech Hunter | Biotech Hunter