TetanusPhase 3NCT00197275
Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants
A Phase 3 study testing Hib-MenAC mixed with Tritanrix™-HepB in people with Tetanus and Hepatitis B, run by GlaxoSmithKline at 3 sites in Thailand.
Trial summary
The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and… Read more about this study
- Who is it for?
- Ages 56 to 83 daysHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Hepatitis B, Haemophilus Influenzae Type b
- What is being tested?
- Hib-MenAC mixed with Tritanrix™-HepB
- How many people
- 800 participants
- Where
- 3 sitesThailand
- Study dates
- Feb 2006to Nov 2006
- 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 male or female, between, and including, 56 and 83 days of age.
- Born after a gestation period between 36 and 42 weeks
- Birth dose of hepatitis B vaccine within the first 72 hours of life
Who cannot join
- 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.
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- History of OR previous vaccination against OR known exposure since birth to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- A family history of congenital or hereditary immunodeficiency
- History of any neurologic disorders or seizures
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Khon Kaen, 40002
GSK Investigational Site
Songkhla, 90110
About this study
Official title: Demonstrate Lot-to-lot Consistency of Final Production Method of GSK Biologicals' Hib-MenAC Vaccine Mixed Extemporaneously With Tritanrix™-HepB & Demonstrate Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Healthy Infants at 2, 4 and 6 Months
The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single injection.
Read the detailed description
The study is double blind. However the active control vaccine Tritanrix™-HepB/Hiberix™ will be administered in a single-blind manner. Blood samples will be collected for immunogenicity analyses. GSK Biologicals' OPV vaccine will be administered concomitantly with the study vaccines at 2, 4 and 6 months of age according to local country regulation. The study will last approximately 5 months per subject
- Being tested
- Hib-MenAC mixed with Tritanrix™-HepB
- Keywords
- Haemophilus influenzae type b, diphtheria, tetanus, Prophylaxis diphtheria, pertussis, hepatitis B, meningococcal serogroups A & C diseases
- Medical subject headings
- Tetanus, Hepatitis B, Haemophilus Infections, Diphtheria, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hib-MenAC mixed with Tritanrix™-HepBBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response 1 month post dose 3 (SBA-MenA/C titers ≥ 1:8, anti-PRP ≥ 0.15 µg/ml, -diphtheria ≥ 0.1 IU/ml (ELISA) OR ≥ 0.016 IU/ml (Vero-cell test), -tetanus ≥ 0.1 IU/ml, -HB concentration ≥ 10 mIU/ml, vaccine response to Bordetella pertus
Secondary outcomes (1)
Antibody conc or titer, seroprot, seropos and/or vacc response to all antigens administered (Prior to dose 1, 2 m after dose 2 & 1m after dose 3). After each dose: Solicited (d 0-3, local/general), unsolicited (d 0-30) symptoms. During whole study: SAEs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TetanusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Enrolment
- 800 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197275
- Sponsor's protocol ID
- 104733
- Status last verified
- Oct 2016
- First submitted
- 19 Sep 2005
- Last updated
- 7 Oct 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Guignard A, Haguinet F, Wery S, Kerdpanich P. Prevalence and Persistence of Maternal Dengue Neutralizing Antibodies in Infants From Central and Southern Thailand: A Retrospective Cohort Study. Asia Pac J Public Health. 2019 May;31(4):288-295. doi: 10.1177/1010539519853396.
PubMed 31307216
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstrate Lot-to-lot Consistency of Final Production Method of GSK Biologicals' Hib-MenAC Vaccine Mixed Extemporaneously With Tritanrix™-HepB & Demonstrate Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Healthy Infants at 2, 4 and 6 Months
- ClinicalTrials.gov ID
- NCT00197275
- Acronym / sponsor ID
- 104733
- Keywords
- Haemophilus influenzae type b, diphtheria, tetanus, Prophylaxis diphtheria, pertussis, hepatitis B, meningococcal serogroups A & C diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single injection.
Detailed description
The study is double blind. However the active control vaccine Tritanrix™-HepB/Hiberix™ will be administered in a single-blind manner. Blood samples will be collected for immunogenicity analyses. GSK Biologicals' OPV vaccine will be administered concomitantly with the study vaccines at 2, 4 and 6 months of age according to local country regulation. The study will last approximately 5 months per subject
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 56 to 83 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- healthy male or female, between, and including, 56 and 83 days of age.
- Born after a gestation period between 36 and 42 weeks
- Birth dose of hepatitis B vaccine within the first 72 hours of life
Key exclusion criteria (7 listed)
- 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.
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- History of OR previous vaccination against OR known exposure since birth to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- A family history of congenital or hereditary immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hib-MenAC mixed with Tritanrix™-HepB | Biological | – |
Primary outcome
Immune response 1 month post dose 3 (SBA-MenA/C titers ≥ 1:8, anti-PRP ≥ 0.15 µg/ml, -diphtheria ≥ 0.1 IU/ml (ELISA) OR ≥ 0.016 IU/ml (Vero-cell test), -tetanus ≥ 0.1 IU/ml, -HB concentration ≥ 10 mIU/ml, vaccine response to Bordetella pertus
1 secondary outcome
Antibody conc or titer, seroprot, seropos and/or vacc response to all antigens administered (Prior to dose 1, 2 m after dose 2 & 1m after dose 3). After each dose: Solicited (d 0-3, local/general), unsolicited (d 0-30) symptoms. During whole study: SAEs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Derived from this study: PubMed 31307216Guignard A, Haguinet F, Wery S, Kerdpanich P. Prevalence and Persistence of Maternal Dengue Neutralizing Antibodies in Infants From Central and Southern Thailand: A Retrospective Cohort Study. Asia Pac J Public Health. 2019 May;31(4):288-295. doi: 10.1177/1010539519853396.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hib-MenAC mixed with Tritanrix™-HepB in people with Tetanus and Hepatitis B, run by GlaxoSmithKline at 3 sites 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 3 inclusion and 7 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 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Immune response 1 month post dose 3 (SBA-MenA/C titers ≥ 1:8, anti-PRP ≥ 0.15 µg/ml, -diphtheria ≥ 0.1 IU/ml (ELISA) OR ≥ 0.016 IU/ml (Vero-cell test), -tetanus ≥ 0.1 IU/ml, -HB concentration ≥ 10 mIU/ml, vaccine response to Bordetella pertus. 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 NCT00197275, 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 7 Oct 2016.