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

Merck Sharp & Dohme LLC1,718 enrolled

Overview

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®).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,718

Conditions

Hepatitis B

Interventions

Modified Process Hepatitis B Vaccine (Experimental)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).

Hepatitis B Vaccine (Recombinant)BIOLOGICAL

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

Hepatitis B Vaccine (Recombinant)BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 2 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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®

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%.

Time frame: 7 months of age (1 month after 3 doses)

Secondary Outcomes

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®

Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.

Time frame: 7 months of age (1 month after 3 doses)

Data from ClinicalTrials.gov

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