Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)

March 2, 2015 updated by: Merck Sharp & Dohme LLC

A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus Influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process

To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

546

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

1 month to 2 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy 2-month-old full term infants born to non-HBs Ag (hepatitis B virus) carrier mothers

Exclusion Criteria:

  • Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or known carriers ever living in close contact with the subject
  • History of previous hepatitis B infection; history of vaccination with any hepatitis B vaccine
  • Recent (<72 hours) history of febrile illness (rectal temperature >=38.1°C/>=100.5°F)
  • Known or suspected hypersensitivity to any component of RECOMBIVAXHB™ or COMVAX™ (e.g., aluminum, yeast)
  • Recent administration (w/i 3 months prior to study start) of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
  • Receipt of investigational drugs or investigational vaccines within 3 months prior to study start or if planned within the study period;
  • Known or suspected impairment of immunologic function or recent use (within 3 months prior to study start) of immunomodulatory medications (does not include topical and inhaled steroids);
  • Any condition that, in the opinion of the investigator, might interfere with the evaluation of study objectives; or inability to comply with the study schedule and/or inability to attend all required study visits

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Modified process Hib/Hep B vaccine
Biological: Comparator: Modified Process Vaccine
Modified process vaccine HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 & 12 months of age. Duration of treatment is 11 months.
ACTIVE_COMPARATOR: 2
COMVAX™
Biological: Comparator: COMVAX™
COMVAX™ HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.
Time Frame: 11 months (1 month after the third dose)
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 Month 11 (1 month after the third dose)
11 months (1 month after the third dose)
The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.
Time Frame: 11 months (1 month after the third dose)
Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).
11 months (1 month after the third dose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
Time Frame: 0-11 months (recorded from first dose until the participant completes or discontinues)
Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose)
0-11 months (recorded from first dose until the participant completes or discontinues)
The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.
Time Frame: 11 months (1 month after the third dose)

The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after

the third dose)
11 months (1 month after the third dose)
The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.
Time Frame: 11 months (1 month after the third dose)
Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
11 months (1 month after the third dose)

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

December 1, 2006

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

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 (ESTIMATE)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V121-019
  • 2007_513

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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