DiphtheriaPhase 3NCT00254969
Immunogenicity and Safety of Pentaxim in South African Infants
A Phase 3 study testing Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib in people with Diphtheria and Tetanus, run by Sanofi at 1 site in South Africa.
Trial summary
The present clinical study will assess the immunogenicity and reactogenicity 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 in order to meet the requirements for… Read more about this study
- Who is it for?
- Ages 24 hours and olderHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Haemophilus Infections
- What is being tested?
- Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteSouth Africa
- Study dates
- Oct 2005to Jan 2010
- 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 24 hours and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged < 24 hours on the day of inclusion
Who cannot join
- At visit 01 (screening)
- Illness at a stage that could interfere with trial conduct or completion.
- Any vaccination preceding the trial participation (except Bacille Calmette-Guerin [BCG])
- Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).
- Planned participation in another clinical trial during the present trial period
- Blood or blood-derived products received since birth.
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- Mother known as seropositive to HIV or hepatitis B.
- Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of/current seizures at visit 02 (first study vaccination)
- Participation in another clinical trial preceding the first trial vaccination
- 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.
- Any vaccination preceding the first trial vaccination (except BCG)
- History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection (confirmed either clinically, serologically or microbiologically).
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or another vaccine.
- Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of first vaccination
Trial locations and contacts
1 site in 1 country.
About this study
The present clinical study will assess the immunogenicity and reactogenicity 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 in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.
- Conditions
- Diphtheria, Tetanus, Haemophilus Infections, Pertussis, Poliomyelitis
- Being tested
- Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
- Keywords
- Diphteria, tetanus, haemophilus influenzae type b, poliomyelitis, pertussis
- Medical subject headings
- Diphtheria, Tetanus, Haemophilus Infections, Whooping Cough, Poliomyelitis
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 HibBiological
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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the immunogenicity of 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 startOct 2005
- Primary completionMay 2008
- Study completionJan 2010
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 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
- 212 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
- NCT00254969
- Sponsor's protocol ID
- E2I43
- Status last verified
- Apr 2012
- First submitted
- 15 Nov 2005
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Madhi SA, Cutland C, Jones S, Groome M, Ortiz E. One-year post-primary antibody persistence and booster immune response to a DTaP-IPV//PRP~T vaccine (Pentaxim) given at 18 - 19 months of age in South African children primed at 6, 10 and 14 weeks of age with the same vaccine. S Afr Med J. 2011 Nov 28;101(12):879-83.
PubMed 22273029
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Pentaxim in South African Infants
- ClinicalTrials.gov ID
- NCT00254969
- Acronym / sponsor ID
- E2I43
- Conditions
- Diphtheria, Tetanus, Haemophilus Infections, Pertussis, Poliomyelitis
- Keywords
- Diphteria, tetanus, haemophilus influenzae type b, poliomyelitis, pertussis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Jan 2010 (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 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 in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.
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 |
Who may qualify
- Ages
- 24 hours and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Aged < 24 hours on the day of inclusion
Key exclusion criteria (17 listed)
- At visit 01 (screening)
- Illness at a stage that could interfere with trial conduct or completion.
- Any vaccination preceding the trial participation (except Bacille Calmette-Guerin [BCG])
- Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).
- Planned participation in another clinical trial during the present trial period
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 HibAlso: PENTAXIM™0.5 mL, Im | Biological | 1 |
Primary outcome
To provide information concerning the immunogenicity of 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 17 Apr 2012.
- Derived from this study: PubMed 22273029Madhi SA, Cutland C, Jones S, Groome M, Ortiz E. One-year post-primary antibody persistence and booster immune response to a DTaP-IPV//PRP~T vaccine (Pentaxim) given at 18 - 19 months of age in South African children primed at 6, 10 and 14 weeks of age with the same vaccine. S Afr Med J. 2011 Nov 28;101(12):879-83.
- 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 Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib in people with Diphtheria and Tetanus, run by Sanofi at 1 site in South Africa.
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 17 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 17 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 Africa. 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 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?
On the ClinicalTrials.gov record for NCT00254969, 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 17 Apr 2012.