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Hepatitis BPhase 3NCT00317187

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

A Phase 3 study testing Tritanrix-HepB/Meningitec conjugate vaccine and Tritanrix/Hiberix vaccine in people with Hepatitis B and Diphtheria, run by GlaxoSmithKline at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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™. Read more about this study

Who is it for?
Ages 56 to 83 daysHealthy volunteers can take part
Conditions the study is for
Hepatitis B, Diphtheria, Whole Cell Pertussis
What is being tested?
Tritanrix-HepB/Meningitec conjugate vaccine and Tritanrix/Hiberix vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteThailand
Study dates
8 Jun 2004to 16 Jan 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 56 to 83 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • GSK Investigational Site

    Bangkok, 10400

Other trials in Thailand

About this study

Official title: 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™.

Read the 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™
Being tested
Tritanrix-HepB/Meningitec conjugate vaccine, Tritanrix/Hiberix vaccine
Medical subject headings
Hepatitis B, Diphtheria, Tetanus, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tritanrix-HepB/Meningitec conjugate vaccineBiological

    Also called DTPw-HBV/Hib-MenAC 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

  • Tritanrix/Hiberix vaccineBiological

    Also called DTPw-HBV/Hib 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.

Study groups in NCT00317187
Study groupRoleWhat they receive
Hib-MenAC Lot 1 GroupExperimentalHealthy 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.
Receives: Biological: Tritanrix-HepB/Meningitec conjugate vaccine
Hib-MenAC Lot 2 GroupExperimentalHealthy 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.
Receives: Biological: Tritanrix-HepB/Meningitec conjugate vaccine
Hib-MenAC Lot 3 GroupExperimentalHealthy 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.
Receives: Biological: Tritanrix-HepB/Meningitec conjugate vaccine
Hiberix GroupActive comparatorHealthy 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.
Receives: Biological: Tritanrix/Hiberix vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1

    Measured: Days 0-3 post dose 1

  2. Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2

    Measured: Days 0-3 post dose 2

  3. Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3

    Measured: Days 0-3 post dose 3

Secondary outcomes (3)

  1. Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose

    Measured: Days 0-3 after each dose

  2. Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose

    Measured: Day 0-30 after each dose

  3. Occurrence of serious adverse events during the entire study period

    Measured: Day 0 up to Month 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2006 (estimated)
  2. Study start8 Jun 2004
  3. Primary completion16 Jan 2005
  4. Study completion16 Jan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00317187
Sponsor's protocol ID
100791
Status last verified
Aug 2018
First submitted
17 Feb 2006
Last updated
15 Aug 2018
Results posted
No

Publications

  • Kerdpanich A, Warachit B, Kosuwon P, Gatchalian SR, Watanaveeradej V, Borkird T, Kosalaraksa P, Han HH, Hutagalung Y, Boutriau D, Dobbelaere K. Primary vaccination with a new heptavalent DTPw-HBV/Hib-Neisseria meningitidis serogroups A and C combined vaccine is well tolerated. Int J Infect Dis. 2008 Jan;12(1):88-97. doi: 10.1016/j.ijid.2007.06.002. Epub 2007 Aug 22.

    PubMed 17716936

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tritanrix-HepB/Meningitec conjugate vaccine and Tritanrix/Hiberix vaccine in people with Hepatitis B and Diphtheria, run by GlaxoSmithKline at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00317187, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.

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