- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00317135
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
Assess Reactogenicity and Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Compared to Tritanrix™-HepB/Hiberix™ (Control) in Healthy Infants (2,4,6 Months Age), 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
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
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Muntinlupa, Philippines, 1781
- GSK Investigational Site
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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
No older than 3 days (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria at study entry:
- Healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
Exclusion criteria at study entry:
- Any confirmed immunodeficient condition, based on medical history & physical examination.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute disease at the time of enrolment.
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
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.
|
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:
|
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.
|
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:
|
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.
|
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:
|
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.
|
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:
|
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
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Days 0-3 post dose 1
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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
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Days 0-3 post dose 2
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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
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Days 0-3 post dose 3
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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
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Days 0-3 after each dose
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Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose
Time Frame: Day 0-30 after each dose
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Day 0-30 after each dose
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Occurrence of serious adverse events during the entire study period
Time Frame: Day 0 up to Month 5
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Day 0 up to Month 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 11, 2003
Primary Completion (ACTUAL)
October 23, 2004
Study Completion (ACTUAL)
October 23, 2004
Study Registration Dates
First Submitted
February 15, 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
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Enterovirus Infections
- Picornaviridae Infections
- Corynebacterium Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Diphtheria
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 759346/004
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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