Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell PertussisPhase 3NCT00317122
Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth
A Phase 3 study testing DTPw-HBV/Hib-MenAC conjugate vaccine in people with Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis, run by GlaxoSmithKline at 4 sites in South Africa.
Trial summary
This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) \& hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least… Read more about this study
- Who is it for?
- Ages 4 to 10 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis
- What is being tested?
- DTPw-HBV/Hib-MenAC conjugate vaccine
- Type of treatment
- Vaccines
- How many people
- 192 participants
- Where
- 4 sitesSouth Africa
- Study dates
- Oct 2004to Jul 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 4 to 10 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for HIV \& HBsAg, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
Who cannot join
- Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease since birth.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious illness.
- Any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- A birth dose of hepatitis B vaccine given outside the frame of this study.
Trial locations and contacts
4 sites in 1 country.
South Africa4 sites
GSK Investigational Site
Brits, 0250
GSK Investigational Site
Brits
GSK Investigational Site
Centurion
GSK Investigational Site
Ga-Rankuwa, 0208
About this study
Official title: Demonstrate Non-inferiority of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ With Respect to Anti-HBs Immune Response, When Given to Healthy Infants at 6,10 & 14 Weeks Age, After a Birth Dose of Hepatitis B Vaccine
This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) \& hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.
Read the detailed description
Randomized study with two groups to receive one of the following vaccination regimens:
- GSK Biologicals' Tritanrix™-HepB/Hib-MenAC
- GSK Biologicals' Tritanrix™-HepB/Hiberix™
- Being tested
- DTPw-HBV/Hib-MenAC conjugate vaccine
- Medical subject headings
- Diphtheria, Haemophilus Infections, Hepatitis B, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTPw-HBV/Hib-MenAC conjugate vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.
Secondary outcomes (2)
Immunogenicity: One month after the third dose of the primary vaccination, antibody concentrations or titres against all other vaccine antigens.
Reactogenicity and safety: after each dose: solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startOct 2004
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell PertussisStudies 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
- None (open label)
- Enrolment
- 192 participants (actual)
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
- NCT00317122
- Sponsor's protocol ID
- 759346/007
- Status last verified
- Sep 2016
- First submitted
- 23 Feb 2006
- Last updated
- 21 Sep 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstrate Non-inferiority of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ With Respect to Anti-HBs Immune Response, When Given to Healthy Infants at 6,10 & 14 Weeks Age, After a Birth Dose of Hepatitis B Vaccine
- ClinicalTrials.gov ID
- NCT00317122
- Acronym / sponsor ID
- 759346/007
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 24 Apr 2006 (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.
This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) \& hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.
Detailed description
Randomized study with two groups to receive one of the following vaccination regimens:
- GSK Biologicals' Tritanrix™-HepB/Hib-MenAC
- GSK Biologicals' Tritanrix™-HepB/Hiberix™
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 10 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for HIV \& HBsAg, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
Key exclusion criteria (8 listed)
- Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease since birth.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious illness.
- Any neurologic disorders or seizures.
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 |
|---|---|---|
| DTPw-HBV/Hib-MenAC conjugate vaccine | Biological | – |
Primary outcome
One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.
2 secondary outcomes
Immunogenicity: One month after the third dose of the primary vaccination, antibody concentrations or titres against all other vaccine antigens.
Reactogenicity and safety: after each dose: solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (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 21 Sep 2016.
- 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.
Related trials for Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 2/3
A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
Diphtheria, Tetanus
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
4 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 DTPw-HBV/Hib-MenAC conjugate vaccine in people with Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis, run by GlaxoSmithKline at 4 sites in South Africa.
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 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa. 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?
One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2016.