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

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: Modified Process Hepatitis B Vaccine (Experimental); Biological: Hepatitis B Vaccine (Recombinant)

• Registration Number: NCT00414050
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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®).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-10-06
• Study First Submitted: 2006-12-20
• Study First Submitted QC: 2006-12-20
• Study First Posted: 2006-12-21
• Primary Completion: 2007-10-22
• Study Completion: 2007-10-24
• Results First Submitted: 2008-10-15
• Results First Submitted QC: 2009-03-10
• Results First Posted: 2009-04-14
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1718

Inclusion Criteria

• Participant is a healthy infant approximately 2 months of age

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Process Hepatitis B vaccine 10 μg	Modified Process Hepatitis B Vaccine (Experimental)	Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
Modified Process Hepatitis B vaccine 5 μg	Modified Process Hepatitis B Vaccine (Experimental)	Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
RECOMBIVAX HB™ Hepatitis B Vaccine	Hepatitis B Vaccine (Recombinant)	Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
ENGERIX-B®	Hepatitis B Vaccine (Recombinant)	Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.

Primary Outcome Measures

Name	Time	Method
The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®	7 months of age (1 month after 3 doses)	The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.

Secondary Outcome Measures

Name	Time	Method
Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®	7 months of age (1 month after 3 doses)	Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.