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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: Modified Process Hepatitis B Vaccine (Experimental); Biological: Hepatitis B Vaccine (Recombinant)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00414050

2006-001638-42 (EudraCT Number)

2006_053

V232-057

Details and patient eligibility

About

This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).

Enrollment: 1,718 patients

Sex: All

Ages: 2 to 2 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant is a healthy infant approximately 2 months of age

Exclusion criteria

• Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant
• Participant's birth mother did not receive any prenatal care
• Participant has previous history of hepatitis B infection
• Participant has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of participant
• Participant has had a fever within 72 hours of study start
• Participant has received any blood-derived product or birth mother received blood-derived product within 6 months of birth of participant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,718 participants in 4 patient groups

Modified Process Hepatitis B vaccine 5 μg

Experimental group

Description:

Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.

Treatment:

Biological: Modified Process Hepatitis B Vaccine (Experimental)

RECOMBIVAX HB™ Hepatitis B Vaccine

Active Comparator group

Description:

Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.

Treatment:

Biological: Hepatitis B Vaccine (Recombinant)

Biological: Hepatitis B Vaccine (Recombinant)

Modified Process Hepatitis B vaccine 10 μg

Experimental group

Description:

Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.

Treatment:

Biological: Modified Process Hepatitis B Vaccine (Experimental)

ENGERIX-B®

Active Comparator group

Description:

Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.

Treatment:

Biological: Hepatitis B Vaccine (Recombinant)

Biological: Hepatitis B Vaccine (Recombinant)