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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1718 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-06

Study Completion Date

2007-10-24

Brief Summary

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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®).

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Detailed Description

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Conditions

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Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Modified Process Hepatitis B vaccine 5 μg

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

Group Type EXPERIMENTAL

Modified Process Hepatitis B Vaccine (Experimental)

Intervention Type BIOLOGICAL

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).

RECOMBIVAX HB™ Hepatitis B Vaccine

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

Group Type ACTIVE_COMPARATOR

Hepatitis B Vaccine (Recombinant)

Intervention Type BIOLOGICAL

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

Modified Process Hepatitis B vaccine 10 μg

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

Group Type EXPERIMENTAL

Modified Process Hepatitis B Vaccine (Experimental)

Intervention Type BIOLOGICAL

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).

ENGERIX-B®

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

Group Type ACTIVE_COMPARATOR

Hepatitis B Vaccine (Recombinant)

Intervention Type BIOLOGICAL

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

Interventions

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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).

Intervention Type 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.

Intervention Type 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

Intervention Type BIOLOGICAL

Other Intervention Names

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RECOMBIVAX HB™ ENGERIX-B®

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes