NCT00414050View on ClinicalTrials.gov

A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,718

Participants

Timeline

Start Date

October 6, 2006

Primary Completion Date

October 22, 2007

Study Completion Date

October 24, 2007

Conditions
Hepatitis B
Interventions
BIOLOGICAL

Modified Process Hepatitis B Vaccine (Experimental)

Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm).

BIOLOGICAL

Hepatitis B Vaccine (Recombinant)

RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.

BIOLOGICAL

Hepatitis B Vaccine (Recombinant)

ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00414050 - A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057) | Biotech Hunter | Biotech Hunter