Haemophilus Influenzae Type bPhase 3NCT00316680
Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.
A Phase 3 study testing Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine in people with Haemophilus Influenzae Type b and Diphtheria, run by GlaxoSmithKline at 1 site in Dominican Republic.
Trial summary
A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenzae Type b, Diphtheria, Tetanus
- What is being tested?
- Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine
- Type of treatment
- Vaccines
- How many people
- 288 participants
- Where
- 1 siteDominican Republic
- Study dates
- Mar 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 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Administration of one dose of hepatitis B vaccine at birth.
- A healthy male or female between, and including, 6 and 12 weeks of age at the time of the first DTPw vaccination.
Who cannot join
- Use of any investigational or non-registered product (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 of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine hepatitis B vaccine for the Triple Antigen + Hib group.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Bacille Calmette-Guérin (BCG) vaccine given after the first 2 weeks of life.
- Previous vaccination against diphtheria, tetanus, pertussis and/or Hib/History of diphteria, tetanus, pertussis, hepatitis B and/ or hib disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Assess Immunogenicity and Safety of GlaxoSmithKline Biologicals' Kft's DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft and vs Concomitant Administration of CSL's Triple Antigen and GlaxoSmithKline Biologicals' Hiberix, to Infants at 2, 4, 6 Months of Age, After a Birth Dose of Hepatitis B
A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be assessed as well.
Read the detailed description
"The study will be carried out in a partially double blind manner (i.e. double blind with respect to DTPwGöd-HBV/Hib Kft and DTPwCSL-HBV/Hib Kft groups and open with respect to CSL's Triple Antigen \& Hib group). Subjects will be randomly allocated to one of the three following groups to receive:
- GSK Biologicals Kft's combined DTPwGöd-HBV/Hib Kft vaccine.
- GSK Biologicals Kft's combined DTPwCSL-HBV/Hib Kft vaccine.
- CSL's Triple Antigen + GSK Biologicals' Hib vaccines. There will be a specific follow-up of solicited local and general symptoms during 4 days after each vaccination and of unsolicited symptoms for 31 days after each vaccination. Serious adverse events reported during the study period will be recorded.
"
- Being tested
- Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine
- Medical subject headings
- Haemophilus Infections, Diphtheria, Tetanus, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccineBiological
Also called Diphtheria, tetanus, pertussis, hepatitis B
What is being measured
The primary outcome is the main question the study is designed to answer.
GMC of anti-BPT Ab
Secondary outcomes (2)
anti-HBs, anti-diphtheria, anti-tetanus, anti-BPT & anti-PRP conc. & GMCs; vaccine response to BPT
Solicited & unsolicited symptoms, SAEs "
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startMar 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilus Influenzae Type bStudies 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
- Double blind
- Enrolment
- 288 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
- NCT00316680
- Sponsor's protocol ID
- 104489
- Status last verified
- Oct 2016
- First submitted
- 20 Apr 2006
- 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.
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
- Study to Assess Immunogenicity and Safety of GlaxoSmithKline Biologicals' Kft's DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft and vs Concomitant Administration of CSL's Triple Antigen and GlaxoSmithKline Biologicals' Hiberix, to Infants at 2, 4, 6 Months of Age, After a Birth Dose of Hepatitis B
- ClinicalTrials.gov ID
- NCT00316680
- Acronym / sponsor ID
- 104489
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 288 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 21 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.
A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be assessed as well.
Detailed description
"The study will be carried out in a partially double blind manner (i.e. double blind with respect to DTPwGöd-HBV/Hib Kft and DTPwCSL-HBV/Hib Kft groups and open with respect to CSL's Triple Antigen \& Hib group). Subjects will be randomly allocated to one of the three following groups to receive:
- GSK Biologicals Kft's combined DTPwGöd-HBV/Hib Kft vaccine.
- GSK Biologicals Kft's combined DTPwCSL-HBV/Hib Kft vaccine.
- CSL's Triple Antigen + GSK Biologicals' Hib vaccines. There will be a specific follow-up of solicited local and general symptoms during 4 days after each vaccination and of unsolicited symptoms for 31 days after each vaccination. Serious adverse events reported during the study period will be recorded.
"
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Administration of one dose of hepatitis B vaccine at birth.
- A healthy male or female between, and including, 6 and 12 weeks of age at the time of the first DTPw vaccination.
Key exclusion criteria (7 listed)
- Use of any investigational or non-registered product (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 of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine hepatitis B vaccine for the Triple Antigen + Hib group.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
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 |
|---|---|---|
| Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccineAlso: Diphtheria, tetanus, pertussis, hepatitis B | Biological | – |
Primary outcome
GMC of anti-BPT Ab
2 secondary outcomes
anti-HBs, anti-diphtheria, anti-tetanus, anti-BPT & anti-PRP conc. & GMCs; vaccine response to BPT
Solicited & unsolicited symptoms, SAEs "
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine in people with Haemophilus Influenzae Type b and Diphtheria, run by GlaxoSmithKline at 1 site in Dominican Republic.
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 2 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: stopped early, 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 1 site in Dominican Republic. 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 was stopped early. Results are not available in the source record.
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?
GMC of anti-BPT Ab. 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 7 Oct 2016.