DiphtheriaPhase 4NCT01491087
Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
A Phase 4 study testing DTacP IPV//PRP~T combined vaccine: PENTAXIM® in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 3 sites in China.
Trial summary
The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in China, and to generate additional clinical data using the three-dose primary vaccination… 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, Pertussis
- What is being tested?
- DTacP IPV//PRP~T combined vaccine: PENTAXIM®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 3 sitesChina
- Study dates
- Dec 2011to Dec 2012
- 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 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 the first study visit
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- Participation or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- Clinically significant illness, according to investigator judgment, at a stage that could interfere with trial conduct or completion
- Evolving encephalopathy
- Receipt of immune globulins, blood or blood-derived products since birth
Show all 12Show fewer
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection
- Receipt of any other vaccine in the 14 days preceding the first trial vaccination or planned receipt of any vaccine in the 14 days following the first trial vaccination
- Acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- Contraindications to vaccination according to PENTAXIM® summary of product characteristics (SPC) or leaflet
- In an emergency setting, or hospitalized involuntarily
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Study site
Guangzhou, Guangdong, 510300
Study site
Shanghai, 200336
Study site
Tianjin, 300011
About this study
Official title: Safety of the DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM®) Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in China, and to generate additional clinical data using the three-dose primary vaccination schedule in some other Chinese provinces.
Primary Objective
- To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in the study population.
Read the detailed description
Each study participant will receive an injection of PENTAXIM® at 2, 3, and 4 months of age and will be monitored for safety through the entire study period.
The duration of each participant in the trial will be approximately 3 to 4 months.
- Conditions
- Diphtheria, Tetanus, Pertussis, Polio
- Being tested
- DTacP IPV//PRP~T combined vaccine: PENTAXIM®
- Keywords
- Pentaxim®, Whole-cell Pertussis vaccine, Acellular Pertussis vaccine, Haemophilus influenzae type b polysaccharide, Inactivated Polio vaccine, Pentavac®
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTacP IPV//PRP~T combined vaccine: PENTAXIM®Biological
Also called PENTAXIM®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| PENTAXIM® vaccine group | Experimental | Not described Receives: Biological: DTacP IPV//PRP~T combined vaccine: PENTAXIM® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the Safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with PENTAXIM® vaccine
Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability
Measured: Day 0 for up to 3 months post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionDec 2012
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 Sanofi Pasteur, a Sanofi CompanyThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491087
- Sponsor's protocol ID
- E2I60
- Other IDs
- U1111-1117-7233
- Status last verified
- Mar 2013
- First submitted
- 9 Dec 2011
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of the DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM®) Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
- ClinicalTrials.gov ID
- NCT01491087
- Acronym / sponsor ID
- E2I60
- Conditions
- Diphtheria, Tetanus, Pertussis, Polio
- Keywords
- Pentaxim®, Whole-cell Pertussis vaccine, Acellular Pertussis vaccine, Haemophilus influenzae type b polysaccharide, Inactivated Polio vaccine, Pentavac®
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Dec 2011 (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 study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in China, and to generate additional clinical data using the three-dose primary vaccination schedule in some other Chinese provinces.
Primary Objective
- To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in the study population.
Detailed description
Each study participant will receive an injection of PENTAXIM® at 2, 3, and 4 months of age and will be monitored for safety through the entire study period.
The duration of each participant in the trial will be approximately 3 to 4 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PENTAXIM® vaccine group | Experimental | Biological: DTacP IPV//PRP~T combined vaccine: PENTAXIM® |
Who may qualify
- Ages
- 60 to 74 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 2 months (60 to 74 days) inclusive on the day of the first study visit
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Key exclusion criteria (12 listed)
- Participation or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- Clinically significant illness, according to investigator judgment, at a stage that could interfere with trial conduct or completion
- Evolving encephalopathy
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 |
|---|---|---|
| DTacP IPV//PRP~T combined vaccine: PENTAXIM®Also: PENTAXIM®0.5 mL, Intramuscular | Biological | PENTAXIM® vaccine group |
Primary outcome
Description of the Safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with PENTAXIM® vaccine
Time frame: Day 0 for up to 3 months post vaccination
Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability
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 29 Mar 2013.
- 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 SA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DTacP IPV//PRP~T combined vaccine: PENTAXIM® in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 3 sites 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 3 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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
Description of the Safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with PENTAXIM® vaccine (time frame: Day 0 for up to 3 months 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 29 Mar 2013.