DiphtheriaPhase 3NCT00879827
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
A Phase 3 study testing Pediarix TM, Infanrix penta TM and Hiberix TM in people with Diphtheria and Poliomyelitis, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Poliomyelitis, Hepatitis B
- What is being tested?
- Pediarix TM, Infanrix penta TM and Hiberix TM
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to May 2001
- 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 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parents or guardians of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
Who cannot join
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
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- Major congenital defects
- Serious chronic illness
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute disease at the time of enrollment.
About this study
Official title: Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months
The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.
- Conditions
- Diphtheria, Poliomyelitis, Hepatitis B, Tetanus, Acellular Pertussis
- Being tested
- Pediarix TM, Infanrix penta TM, Hiberix TM
- Medical subject headings
- Diphtheria, Poliomyelitis, Hepatitis B, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediarix TM, Infanrix penta TMBiological
The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
Hiberix TMBiological
The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | Not described Receives: Biological: Pediarix TM, Infanrix penta TM; Biological: Hiberix TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-PT, anti-FHA and anti-PRN antibody titers.
Measured: One month after the 3rd dose of the primary vaccination course
Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers
Measured: One month after the 3rd dose of the primary vaccination course
Anti-HBs antibody titers
Measured: One month after the 3rd dose of the primary vaccination course
Anti-polio virus types 1, 2 and 3 antibody titers
Measured: One month after the 3rd dose of the primary vaccination course
Anti-PRP antibody titers
Measured: One month after the 3rd dose of the primary vaccination course
Secondary outcomes (3)
Occurrence of solicited adverse events
Measured: During the 4-day follow-up period after each dose
Occurrence of unsolicited adverse events
Measured: During the 30-day follow-up period after each dose
Occurrence of Serious Adverse Events
Measured: Over the course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startSep 2000
- Primary completionMay 2001
- Study completionMay 2001
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT00879827
- Sponsor's protocol ID
- 217744/049
- Status last verified
- Sep 2016
- First submitted
- 9 Apr 2009
- Last updated
- 7 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.
Publications
Shao PL, Lu CY, Hsieh YC; Taiwan Infanrix-049 Study Group; Bock HL, Huang LM. Immunogenicity and reactogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus and Haemophilus influenzae type B. J Formos Med Assoc. 2011 May;110(5):336-41. doi: 10.1016/S0929-6646(11)60050-8.
PubMed 21621155
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months
- ClinicalTrials.gov ID
- NCT00879827
- Acronym / sponsor ID
- 217744/049
- Conditions
- Diphtheria, Poliomyelitis, Hepatitis B, Tetanus, Acellular Pertussis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Primary completion
- May 2001 (actual)
- Study completion
- May 2001 (actual)
- First posted
- 13 Apr 2009 (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 purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Biological: Pediarix TM, Infanrix penta TM, Biological: Hiberix TM |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parents or guardians of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
Key exclusion criteria (11 listed)
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
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 |
|---|---|---|
| Pediarix TM, Infanrix penta TMThe vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age. | Biological | Single Group |
| Hiberix TMThe vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age. | Biological | Single Group |
Primary outcome
Anti-PT, anti-FHA and anti-PRN antibody titers.
Time frame: One month after the 3rd dose of the primary vaccination course
Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers
Time frame: One month after the 3rd dose of the primary vaccination course
Anti-HBs antibody titers
Time frame: One month after the 3rd dose of the primary vaccination course
Anti-polio virus types 1, 2 and 3 antibody titers
Time frame: One month after the 3rd dose of the primary vaccination course
Anti-PRP antibody titers
Time frame: One month after the 3rd dose of the primary vaccination course
3 secondary outcomes
Occurrence of solicited adverse events
Time frame: During the 4-day follow-up period after each dose
Occurrence of unsolicited adverse events
Time frame: During the 30-day follow-up period after each dose
Occurrence of Serious Adverse Events
Time frame: Over the course of the study
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 Sep 2016.
- Background: PubMed 21621155Shao PL, Lu CY, Hsieh YC; Taiwan Infanrix-049 Study Group; Bock HL, Huang LM. Immunogenicity and reactogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus and Haemophilus influenzae type B. J Formos Med Assoc. 2011 May;110(5):336-41. doi: 10.1016/S0929-6646(11)60050-8.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pediarix TM, Infanrix penta TM and Hiberix TM in people with Diphtheria and Poliomyelitis, run by GlaxoSmithKline.
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 4 inclusion and 11 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 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Anti-PT, anti-FHA and anti-PRN antibody titers. (time frame: One month after the 3rd dose of the primary vaccination course). The study lists 5 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 NCT00879827, 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 Sep 2016.