DiphtheriaPhase 3NCT00259337
Immunogenicity and Safety of Pentaxim™ in an Indian Population
A Phase 3 study testing Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine in people with Diphtheria and Tetanus, run by Sanofi at 1 site in India.
Trial summary
The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the… Read more about this study
- Who is it for?
- Ages 42 to 56 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Polio
- What is being tested?
- Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2006to Dec 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 42 to 56 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 42 to 56 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.
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- Any vaccination preceding the trial vaccination (except BCG and hepatitis B)
- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Haemophilus influenza type b (confirmed either clinically, serologically or microbiologically).
- Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of/current seizures
- Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India.
The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life.
Safety:
This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).
- Conditions
- Diphtheria, Tetanus, Polio, Pertussis, Haemophilus Infections
- Being tested
- Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
- Keywords
- Diphteria, Tetanus, Polio, Acellular Pertussis, Hib, Haemophilus influenzae type B
- Medical subject headings
- Diphtheria, Tetanus, Poliomyelitis, Whooping Cough, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccineBiological
Also called PENTAXIM™
0.5 mL, IM
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startFeb 2006
- Primary completionApr 2008
- Study completionDec 2008
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259337
- Sponsor's protocol ID
- E2I41
- Status last verified
- Apr 2012
- First submitted
- 24 Nov 2005
- Last updated
- 16 Apr 2012
- Results posted
- No
- Data monitoring committee
- 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 the Sanofi Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India.
- ClinicalTrials.gov ID
- NCT00259337
- Acronym / sponsor ID
- E2I41
- Conditions
- Diphtheria, Tetanus, Polio, Pertussis, Haemophilus Infections
- Keywords
- Diphteria, Tetanus, Polio, Acellular Pertussis, Hib, Haemophilus influenzae type B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Nov 2005 (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 as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life.
Safety:
This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine |
Who may qualify
- Ages
- 42 to 56 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 42 to 56 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 (12 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 |
|---|---|---|
| Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccineAlso: PENTAXIM™0.5 mL, IM | Biological | 1 |
Primary outcome
To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine
Time frame: 19 months
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.
Medical Director study director
Sanofi Pasteur Inc.
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 Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine in people with Diphtheria and Tetanus, run by Sanofi at 1 site in India.
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 12 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 India. 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 safety of DTacP-IPV//PRP~T combined vaccine (time frame: 19 months). 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.