Vaccine+HBIG Versus Vaccine+Placebo for Newborns of HBsAg+ Mothers

NACompletedINTERVENTIONAL
Enrollment

259

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

June 30, 2010

Study Completion Date

June 30, 2010

Conditions
Chronic Hepatitis B
Interventions
DRUG

Vaccine+HBIG

Recombinant hepatitis B vaccine at birth, 6 weeks, 10 weeks, and 14 weeks in the dose of 10 mcg (0.5 mL), by intramuscular injection in the anterolateral thigh; PLUS HBIG in the dose of 0.5 mL intramuscularly immediately after birth

DRUG

Vaccine+Placebo

Recombinant hepatitis B vaccine at birth, 6 weeks, 10 weeks, and 14 weeks in the dose of 10 mcg (0.5 mL), by intramuscular injection in the anterolateral thigh; PLUS placebo intramuscularly immediately after birth

Trial Locations (1)

110001

Lady Hardinge Medical College, New Delhi

All Listed Sponsors
collaborator

Indian Council of Medical Research

OTHER_GOV

collaborator

Lady Hardinge Medical College

OTHER_GOV

lead

Govind Ballabh Pant Hospital

OTHER_GOV

NCT01412567 - Vaccine+HBIG Versus Vaccine+Placebo for Newborns of HBsAg+ Mothers | Biotech Hunter | Biotech Hunter