Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

August 13, 2018 updated by: GlaxoSmithKline

Partially Blinded Study to Assess Reactogenicity & Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ in Healthy Infants After a Hepatitis B Birth Dose

The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:

  • One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups)
  • GSK Biologicals' Tritanrix™-HepB/Hiberix™

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • GSK Investigational Site

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 infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis B vaccine within the first 3 days of life.

Exclusion criteria:

  • Any confirmed immunodeficient condition, based on medical history and physical examination.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
  • Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.
  • History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hib-MenAC Lot 1 Group
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 1 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
Biological: Tritanrix-HepB/Meningitec conjugate vaccine
The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection
Other Names:
  • DTPw-HBV/Hib-MenAC conjugate vaccine
Experimental: Hib-MenAC Lot 2 Group
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 2 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
Biological: Tritanrix-HepB/Meningitec conjugate vaccine
The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection
Other Names:
  • DTPw-HBV/Hib-MenAC conjugate vaccine
Experimental: Hib-MenAC Lot 3 Group
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 3 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
Biological: Tritanrix-HepB/Meningitec conjugate vaccine
The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection
Other Names:
  • DTPw-HBV/Hib-MenAC conjugate vaccine
Active Comparator: Hiberix Group
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB vaccine mixed extemporaneously with conjugate vaccine Hiberix at 2, 4 and 6 months of age as intramuscular injection in the anterolateral part of the thigh.
Biological: Tritanrix/Hiberix vaccine
The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.
Other Names:
  • DTPw-HBV/Hib vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1
Time Frame: Days 0-3 post dose 1
Days 0-3 post dose 1
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2
Time Frame: Days 0-3 post dose 2
Days 0-3 post dose 2
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3
Time Frame: Days 0-3 post dose 3
Days 0-3 post dose 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose
Time Frame: Days 0-3 after each dose
Days 0-3 after each dose
Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose
Time Frame: Day 0-30 after each dose
Day 0-30 after each dose
Occurrence of serious adverse events during the entire study period
Time Frame: Day 0 up to Month 5
Day 0 up to Month 5

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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)

June 8, 2004

Primary Completion (Actual)

January 16, 2005

Study Completion (Actual)

January 16, 2005

Study Registration Dates

First Submitted

February 17, 2006

First Submitted That Met QC Criteria

April 20, 2006

First Posted (Estimate)

April 24, 2006

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100791

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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