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

Study Overview
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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®).

Official Title
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A Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Modified Process Hepatitis B Vaccine (Experimental)
* Biological: Hepatitis B Vaccine (Recombinant)
* Biological: Hepatitis B Vaccine (Recombinant)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Process Hepatitis B vaccine 5 μg<br>Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. | Biological: Modified Process Hepatitis B Vaccine (Experimental)<br>* 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).<br>|
| Active Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine<br>Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age. | Biological: Hepatitis B Vaccine (Recombinant)<br>* RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.<br>* Other names: RECOMBIVAX HB™;|
| Experimental: Modified Process Hepatitis B vaccine 10 μg<br>Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. | Biological: Modified Process Hepatitis B Vaccine (Experimental)<br>* 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).<br>|
| Active Comparator: ENGERIX-B®<br>Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age. | Biological: Hepatitis B Vaccine (Recombinant)<br>* ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months<br>* Other names: ENGERIX-B®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%. | 7 months of age (1 month after 3 doses) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 months of age (1 month after 3 doses) |