DiphtheriaPhase 3NCT00320463
Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants
A Phase 3 study testing DTPa-HBV-IPV/Hib vaccine in people with Diphtheria and Hepatitis B, run by GlaxoSmithKline at 4 sites in Russia.
Trial summary
In this study, infants will be randomly allocated into three groups: one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation) the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation) the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be… Read more about this study
- Who is it for?
- Ages 11 to 17 weeksHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Hepatitis B, Poliomyelitis
- What is being tested?
- DTPa-HBV-IPV/Hib vaccine
- Type of treatment
- Vaccines
- How many people
- 415 participants
- Where
- 4 sitesRussia
- Study dates
- Apr 2006to Jan 2007
- 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 11 to 17 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
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 within six months prior to the first vaccine dose.
- Any chronic drug therapy to be continued during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.
- Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- "
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
GSK Investigational Site
Murmansk, 183046
GSK Investigational Site
Perm, 614022
GSK Investigational Site
Syktyvkar, 167002
GSK Investigational Site
Syktyvkar, 167011
About this study
Official title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects
In this study, infants will be randomly allocated into three groups:
- one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
- the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)
- the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.
Read the detailed description
A study to compare the immunogenicity \& safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' DTPa-HBV-IPV/Hib vaccine given in healthy infants at 3,4 \& 5 months age. The immunogenicity \& safety of DTPa-HBV-IPV vaccine will also be evaluated in a 3rd group of subjects Subjects in the group that will receive DTPa-HBV-IPV/Hib vaccine (current formulation) will be the control group for the group that will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
- Conditions
- Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Acellular Pertussis
- Being tested
- DTPa-HBV-IPV/Hib vaccine
- Medical subject headings
- Diphtheria, Hepatitis B, Poliomyelitis, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTPa-HBV-IPV/Hib vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
One month after vaccination, measurement of antibodies against all vaccine antigens.
Secondary outcomes (2)
Immunogenicity: One month after vaccination, vaccine response for the pertussis antigens.
Reactogenicity & 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 posted3 May 2006 (estimated)
- Study startApr 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies 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
- 415 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
- NCT00320463
- Sponsor's protocol ID
- 105910
- Status last verified
- Oct 2016
- First submitted
- 21 Feb 2006
- Last updated
- 12 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 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects
- ClinicalTrials.gov ID
- NCT00320463
- Acronym / sponsor ID
- 105910
- Conditions
- Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Acellular Pertussis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 3 May 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.
In this study, infants will be randomly allocated into three groups:
- one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
- the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)
- the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.
Detailed description
A study to compare the immunogenicity \& safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' DTPa-HBV-IPV/Hib vaccine given in healthy infants at 3,4 \& 5 months age. The immunogenicity \& safety of DTPa-HBV-IPV vaccine will also be evaluated in a 3rd group of subjects Subjects in the group that will receive DTPa-HBV-IPV/Hib vaccine (current formulation) will be the control group for the group that will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 11 to 17 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (8 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 within six months prior to the first vaccine dose.
- Any chronic drug therapy to be continued during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.
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 |
|---|---|---|
| DTPa-HBV-IPV/Hib vaccine | Biological | – |
Primary outcome
One month after vaccination, measurement of antibodies against all vaccine antigens.
2 secondary outcomes
Immunogenicity: One month after vaccination, vaccine response for the pertussis antigens.
Reactogenicity & 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 12 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.
Related trials for Diphtheria
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A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
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Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
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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 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
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 DTPa-HBV-IPV/Hib vaccine in people with Diphtheria and Hepatitis B, run by GlaxoSmithKline at 4 sites in Russia.
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 0 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 12 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 4 sites in Russia. 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 vaccination, measurement of antibodies against all vaccine antigens.. 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 12 Oct 2016.