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

April 12, 2017 updated by: Merck Sharp & Dohme LLC

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1718

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: 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).
Active Comparator: 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.
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.
Other Names:
  • RECOMBIVAX HB™
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
Other Names:
  • ENGERIX-B®
Experimental: 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.
Biological: 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).
Active Comparator: 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.
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.
Other Names:
  • RECOMBIVAX HB™
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
Other Names:
  • ENGERIX-B®

What is the study measuring?

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®
Time Frame: 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%.
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®
Time Frame: 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.
7 months of age (1 month after 3 doses)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2006

Primary Completion (Actual)

October 22, 2007

Study Completion (Actual)

October 24, 2007

Study Registration Dates

First Submitted

December 20, 2006

First Submitted That Met QC Criteria

December 20, 2006

First Posted (Estimate)

December 21, 2006

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V232-057
  • 2006_053
  • 2006-001638-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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