DiphtheriaPhase 3NCT00453570
Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months
A Phase 3 study testing Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib and Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed in people with Diphtheria and Tetanus, run by Sanofi at 1 site in China.
Trial summary
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age… Read more about this study
- Who is it for?
- Ages 60 to 74 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Haemophilus Influenzae Type b
- What is being tested?
- Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib and Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- 1 siteChina
- Study dates
- Mar 2007to Jan 2009
- 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 60 to 74 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 2 months (60 to 74 days) inclusive on the day of inclusion
- Born at full term pregnancy (³36 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 trial inclusion
- 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
Show all 14Show fewer
- Any vaccination performed or planned in the 4 weeks preceding the first trial visit (except BCG and Hepatitis B, which can not be given within 8 days before the first study visit)
- Vaccination planned in the 4 weeks following any trial vaccination (except BCG and Hepatitis B, which can not be given within 8 days before or after the study vaccine(s) administration)
- History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
- Clinical or serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
- 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 (axillary temperature ≥ 37.1°C) or acute illness on the day of inclusion
Trial locations and contacts
1 site in 1 country.
About this study
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.
- Conditions
- Diphtheria, Tetanus, Haemophilus Influenzae Type b, Pertussis, Poliomyelitis
- Being tested
- Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib, Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed
- 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
Diphtheria, Tetanus, Polio, Acellular Pertussis and HibBiological
Also called PENTAXIM™
0.5 mL, IM
Diphtheria, Tetanus, & Acellular Pertussis Combined, AbsorbedBiological
Also called DTacP, Act-HIB™ and IMOVAX Polio™
0.5 mL, IM
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DTacP IPV// PRP~T combined vaccine at 2, 3 and 4 months of age, and a booster dose at 18-20 months of age. Receives: Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib |
| 2 | Experimental | DTacP-IPV// PRP~T combined vaccine at 3, 4 and 5 months of age and a booster dose at 18-20 months of age. Receives: Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib |
| 3 | Active comparator | Control vaccines at 3, 4 and 5 months of age and a booster dose at 18-20 months of age Receives: Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed |
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-dose 3
Secondary outcomes (1)
To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine
Measured: 19 months post-dose 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 792 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
- NCT00453570
- Sponsor's protocol ID
- E2I42
- Status last verified
- Apr 2012
- First submitted
- 28 Mar 2007
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Li RC, Li FX, Li YP, Hou QM, Li CG, Li YN, Chen FS, Hu XZ, Su WB, Zhang SM, Fang HH, Ye Q, Zeng TD, Liu TX, Li XB, Huang YN, Deng ML, Zhang YP, Ortiz E. Antibody persistence at 18-20 months of age and safety and immunogenicity of a booster dose of a combined DTaP-IPV//PRP approximately T vaccine compared to separate vaccines (DTaP, PRP approximately T and IPV) following primary vaccination of healthy infants in the People's Republic of China. Vaccine. 2011 Nov 21;29(50):9337-44. doi: 10.1016/j.vaccine.2011.09.131. Epub 2011 Oct 14.
PubMed 22001281Li RC, Li FX, Li YP, Hou QM, Li CG, Li YN, Chen FS, Hu XZ, Su WB, Zhang SM, Fang HH, Ye Q, Zeng TD, Liu TX, Li XB, Huang YN, Deng ML, Zhang YP, Ortiz E. Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China. Vaccine. 2011 Feb 24;29(10):1913-20. doi: 10.1016/j.vaccine.2010.12.103. Epub 2011 Jan 8.
PubMed 21219984
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 as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months
- ClinicalTrials.gov ID
- NCT00453570
- Acronym / sponsor ID
- E2I42
- Conditions
- Diphtheria, Tetanus, Haemophilus Influenzae Type b, Pertussis, Poliomyelitis
- Keywords
- Diphteria, Tetanus, Haemophilus influenzae type b, Poliomyelitis, Pertussis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 29 Mar 2007 (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.
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and HibDTacP IPV// PRP~T combined vaccine at 2, 3 and 4 months of age, and a booster dose at 18-20 months of age. |
| 2 | Experimental | Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and HibDTacP-IPV// PRP~T combined vaccine at 3, 4 and 5 months of age and a booster dose at 18-20 months of age. |
| 3 | Active comparator | Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, AbsorbedControl vaccines at 3, 4 and 5 months of age and a booster dose at 18-20 months of age |
Who may qualify
- Ages
- 60 to 74 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 2 months (60 to 74 days) inclusive on the day of inclusion
- Born at full term pregnancy (³36 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 (14 listed)
- Participation in another clinical trial in the 4 weeks preceding the trial inclusion
- 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 |
|---|---|---|
| Diphtheria, Tetanus, Polio, Acellular Pertussis and HibAlso: PENTAXIM™0.5 mL, IM | Biological | 1 |
| Diphtheria, Tetanus, Polio, Acellular Pertussis and HibAlso: PENTAXIM™0.5 mL, IM | Biological | 2 |
| Diphtheria, Tetanus, & Acellular Pertussis Combined, AbsorbedAlso: DTacP, Act-HIB™ and IMOVAX Polio™0.5 mL, IM | Biological | 3 |
Primary outcome
To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine
Time frame: 1 Month post-dose 3
1 secondary outcome
To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine
Time frame: 19 months post-dose 1
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 22001281Li RC, Li FX, Li YP, Hou QM, Li CG, Li YN, Chen FS, Hu XZ, Su WB, Zhang SM, Fang HH, Ye Q, Zeng TD, Liu TX, Li XB, Huang YN, Deng ML, Zhang YP, Ortiz E. Antibody persistence at 18-20 months of age and safety and immunogenicity of a booster dose of a combined DTaP-IPV//PRP approximately T vaccine compared to separate vaccines (DTaP, PRP approximately T and IPV) following primary vaccination of healthy infants in the People's Republic of China. Vaccine. 2011 Nov 21;29(50):9337-44. doi: 10.1016/j.vaccine.2011.09.131. Epub 2011 Oct 14.
- Derived from this study: PubMed 21219984Li RC, Li FX, Li YP, Hou QM, Li CG, Li YN, Chen FS, Hu XZ, Su WB, Zhang SM, Fang HH, Ye Q, Zeng TD, Liu TX, Li XB, Huang YN, Deng ML, Zhang YP, Ortiz E. Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China. Vaccine. 2011 Feb 24;29(10):1913-20. doi: 10.1016/j.vaccine.2010.12.103. Epub 2011 Jan 8.
- 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 and Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed in people with Diphtheria and Tetanus, run by Sanofi at 1 site in China.
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 14 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 China. 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-dose 3). 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 NCT00453570, which also lists 2 linked publications.
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.