Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

March 16, 2017 updated by: Merck Sharp & Dohme LLC

A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process

The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

540

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female older adults greater than or equal to 50 years of age

Exclusion Criteria:

  • Any adult with a history of previous hepatitis B infection
  • A history of vaccination with any hepatitis B vaccine
  • Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
  • Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
  • Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product
  • Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
  • Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
  • Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
  • Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
  • Pregnant women, nursing mothers, and women planning to become pregnant within the study period
  • Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives

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
Active Comparator: 1
RECOMBIVAX HB™
Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)
RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
Experimental: 2
Modified Process Hepatitis B Vaccine
Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)
Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
Active Comparator: 3
ENGERIX-B™
Biological: Comparator: ENGERIX-B™ (currently licensed product)
ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)
Time Frame: 7 months (1 month after third vaccination)
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).
7 months (1 month after third vaccination)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)
Time Frame: 7 months (1 month after third vaccination)
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).
7 months (1 month after third vaccination)
The Total Number of Participants With One or More Injection-site Adverse Experiences
Time Frame: Days 1-5 After Any Vaccination
Days 1-5 After Any Vaccination
The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C
Time Frame: Day 1-5 After Vaccination
Day 1-5 After Vaccination
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
Time Frame: During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)
During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)

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

November 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 26, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V232-059
  • 2007_516

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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