PertussisPhase 3NCT00319852
Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
A Phase 3 study testing DTaP-IPV combined vaccine and DTaP vaccine in people with Pertussis and Diphtheria, run by Sanofi at 1 site in South Korea.
Trial summary
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available vaccines in order to meet the requirements for registration of the product in South Korea. Read more about this study
- Who is it for?
- Ages 56 to 70 daysHealthy volunteers can take part
- Conditions the study is for
- Pertussis, Diphtheria, Poliomyelitis
- What is being tested?
- DTaP-IPV combined vaccine and DTaP vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2006to Jul 2008
- 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 70 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 56 to 70 days inclusive on the day of inclusion
- Born at full term pregnancy (>37 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by the parent(s) or other legal representative
- Able to attend all scheduled visits and to comply with all trial procedures
Who cannot join
- Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
- Planned participation in another clinical trial during the present trial period.
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Blood or blood-derived products received in the past or planned administration during the trial (including immunoglobulins).
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- Any vaccination in the 3 weeks preceding the first trial vaccination.
- History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically).
- Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases with the trial vaccine or another vaccine.
- Thrombocytopenia or a bleeding disorders contraindicating intramuscular vaccination
- History of major neurological diseases or seizures.
- Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) on the day of inclusion.
- Known family history of congenital or genetic immuno-deficiency.
Trial locations and contacts
1 site in 1 country.
About this study
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available vaccines in order to meet the requirements for registration of the product in South Korea.
Primary objective To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines, one month after the three-dose primary vaccination.
Read more
Secondary objectives
- Immunogenicity: To assess the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France). To assess and describe the immunogenicity of the study vaccines in both groups.
- Safety: To assess and describe the safety of the study vaccines after each dose.
- Conditions
- Pertussis, Diphtheria, Poliomyelitis, Tetanus
- Being tested
- DTaP-IPV combined vaccine, DTaP vaccine
- Keywords
- Diphteria;, Tetanus;, Pertussis;, Poliomyelitis;, acellular
- Medical subject headings
- Whooping Cough, Diphtheria, Poliomyelitis, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTaP-IPV combined vaccineBiological
Also called TETRAXIM™: Diphtheria, Tetanus, Polio, Acellular Pertussis
0.5 mL, IM
DTaP vaccineBiological
Also called DTaP vaccine (CJ purified PDT vaccine ™)
0.5 mL, IM
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: DTaP-IPV combined vaccine |
| 2 | Active comparator | Not described Receives: Biological: DTaP vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the immunogenicity of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines.
Measured: 1 month post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319852
- Sponsor's protocol ID
- E2I28
- Status last verified
- Apr 2012
- First submitted
- 28 Apr 2006
- Last updated
- 16 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
- ClinicalTrials.gov ID
- NCT00319852
- Acronym / sponsor ID
- E2I28
- Conditions
- Pertussis, Diphtheria, Poliomyelitis, Tetanus
- Keywords
- Diphteria;, Tetanus;, Pertussis;, Poliomyelitis;, acellular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 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.
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available vaccines in order to meet the requirements for registration of the product in South Korea.
Primary objective To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines, one month after the three-dose primary vaccination.
Secondary objectives
- Immunogenicity: To assess the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France). To assess and describe the immunogenicity of the study vaccines in both groups.
- Safety: To assess and describe the safety of the study vaccines after each dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: DTaP-IPV combined vaccine |
| 2 | Active comparator | Biological: DTaP vaccine |
Who may qualify
- Ages
- 56 to 70 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 56 to 70 days inclusive on the day of inclusion
- Born at full term pregnancy (>37 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by the parent(s) or other legal representative
- Able to attend all scheduled visits and to comply with all trial procedures
Key exclusion criteria (13 listed)
- Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
- Planned participation in another clinical trial during the present trial period.
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Chronic illness at a stage that could interfere with trial conduct or completion.
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 |
|---|---|---|
| DTaP-IPV combined vaccineAlso: TETRAXIM™: Diphtheria, Tetanus, Polio, Acellular Pertussis0.5 mL, IM | Biological | 1 |
| DTaP vaccineAlso: DTaP vaccine (CJ purified PDT vaccine ™)0.5 mL, IM | Biological | 2 |
Primary outcome
To provide information concerning the immunogenicity of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines.
Time frame: 1 month post-vaccination
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 16 Apr 2012.
- Related InfoLink provided by the sponsor.
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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.
Clinical Trials study director
Sanofi Pasteur, a Sanofi Company
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 DTaP-IPV combined vaccine and DTaP vaccine in people with Pertussis and Diphtheria, run by Sanofi at 1 site in South Korea.
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 13 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 16 Apr 2012. 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 South Korea. 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?
To provide information concerning the immunogenicity of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines. (time frame: 1 month post-vaccination). 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 16 Apr 2012.