DiphtheriaPhase 4NCT00255021
Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
A Phase 4 study testing Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac in people with Diphtheria and Tetanus, run by Sanofi at 1 site in Thailand.
Trial summary
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at… Read more about this study
- Who is it for?
- Ages 2 to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Poliomyelitis
- What is being tested?
- Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2005to Jan 2009
- Phase
- Phase 4
- 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 2 to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 53 to 70 days inclusive on the day of inclusion
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 corticosteroid 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.
Show all 13Show fewer
- Mother known as seropositive to HIV or hepatitis B
- Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin [BCG])
- History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically).
- Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae 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
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.
- Conditions
- Diphtheria, Tetanus, Poliomyelitis, Haemophilus Infections, Pertussis
- Being tested
- Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
- Keywords
- Diphteria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, acellular
- Medical subject headings
- Diphtheria, Tetanus, Poliomyelitis, Haemophilus Infections, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib VacBiological
Also called PENTAXIM
0.5 mL, IM
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine
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 posted17 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionSep 2007
- Study completionJan 2009
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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 186 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
- NCT00255021
- Sponsor's protocol ID
- E2I34
- Status last verified
- Apr 2012
- First submitted
- 15 Nov 2005
- 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 Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
- ClinicalTrials.gov ID
- NCT00255021
- Acronym / sponsor ID
- E2I34
- Conditions
- Diphtheria, Tetanus, Poliomyelitis, Haemophilus Infections, Pertussis
- Keywords
- Diphteria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, acellular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 17 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 and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.
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: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac |
Who may qualify
- Ages
- 2 to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Aged 53 to 70 days inclusive on the day of inclusion
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 corticosteroid 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 |
|---|---|---|
| Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib VacAlso: PENTAXIM0.5 mL, IM | Biological | 1 |
Primary outcome
Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine
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 4 study testing Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac in people with Diphtheria and Tetanus, run by Sanofi at 1 site in Thailand.
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 1 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 Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine (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.