The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates

PHASE3CompletedINTERVENTIONAL
Enrollment

1,740

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

June 30, 2010

Study Completion Date

September 30, 2010

Conditions
Virus DiseaseDNA Virus InfectionsHepadnaviridae Infections
Interventions
BIOLOGICAL

Experimental recombinant hepatitis B vaccine, HBIG

Experimental 10mcg/0.5 ml recombinant hepatitis B vaccine and 200IU HBIG

BIOLOGICAL

Active Comparator hepatitis B vaccine

Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine,200IU HBIG

BIOLOGICAL

Experimental recombinant hepatitis B vaccine

Experimental 10mcg/0.5 ml of recombinant hepatitis B vaccine

BIOLOGICAL

Active Comparator recombinant hepatitis B vaccine.

Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.

BIOLOGICAL

Placebo Comparator recombinant hepatitis B vaccine

Placebo Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.

Trial Locations (1)

210009

Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing

All Listed Sponsors
lead

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

NCT01183611 - The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates | Biotech Hunter | Biotech Hunter