Diphtheria, Tetanus and PertussisNCT01583049
Post Authorisation Safety Study of Triaxis as a 5th Dose in 4-6 Year Old Spanish Children
An observational study of Diphtheria, Tetanus and Pertussis, run by Sanofi Pasteur, a Sanofi Company at 22 sites in Spain.
Trial summary
Primary objective: This is a descriptive study and the primary objective is to determine the incidence of injection site and systemic adverse events after Triaxis administration as a 5th dose of tetanus, diphtheria and acellular pertussis vaccine in 4-6 year old children Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus and Pertussis
- How many people
- 556 participants
- Where
- 22 sitesSpain
- Study dates
- Mar 2012to Aug 2012
- Phase
- Observational
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children between 4-6 years of age who attend the investigator's office to receive a 5th dose of tetanus, diphtheria and pertussis Triaxis vaccine as part of the routine vaccination schedule, as described in the Spanish version of the EU SmPC and local vaccination calendar
Who may be able to join
- Aged 4 to 6 years on the day of enrolment.
- Have received, on the day of enrolment, immunisation with Triaxis as a 5th dose for diphtheria, tetanus, pertussis vaccination in routine practice in accordance with the Spanish version of the EU SmPC and the Spanish immunisation recommendations.
- Have received a complete course of immunisation with diphtheria, tetanus and pertussis (4 doses).
- Participant and participant´s parent/legal representative are able to comply with all study procedures.
- Written informed consent obtained from at least one parent/legal representative of the participant before the participant is enrolled in the study
Who cannot join
- Have been previously vaccinated with a 5th dose of tetanus, diphtheria and pertussis.
- Presence of a contra-indication or cautions to vaccination in accordance with the Spanish version of the EU SmPC:
- Hypersensitivity to vaccines of diphtheria, tetanus or pertussis, any component of the vaccine and any residual component of the manufacturing process such as formaldehyde and glutaraldehyde that may be present in trace amounts.
- Encephalopathy of unknown origin within 7 days after a prior immunisation with a vaccine against pertussis.
- Progressive neurological disorder, uncontrolled epilepsy, progressive encephalopathy if no treatment has been established and the condition is not stable.
- Acute severe febrile illness or acute infection.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Spain22 sites
Centre 11
Almería
Centre 12
Almería
Centre 13
Almería
Centre 14
Almería
Centre 15
Almería
Centre 16
Almería
Centre 17
Almería
Centre 18
Almería
Centre 19
Almería
Centre 20
Almería
Centre 21
Almería
Centre 22
Almería
Centre 10
Madrid
Centre 1
Madrid
Centre 2
Madrid
Centre 3
Madrid
Centre 4
Madrid
Centre 5
Madrid
Centre 6
Madrid
Centre 7
Madrid
Centre 8
Madrid
Centre 9
Madrid
About this study
Official title: Observational Post Authorisation Safety Study to Describe the Safety Profile of the Diphtheria, Tetanus, Acellular Pertussis Combination Vaccine, Reduced Antigen Content (Triaxis) as a 5th Dose in 4-6 Year Old Spanish Children
Primary objective: This is a descriptive study and the primary objective is to determine the incidence of injection site and systemic adverse events after Triaxis administration as a 5th dose of tetanus, diphtheria and acellular pertussis vaccine in 4-6 year old children
- Conditions
- Diphtheria, Tetanus and Pertussis
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough
What is being measured
The primary outcome is the main question the study is designed to answer.
All Injection Site and Systemic Adverse Events
Measured: 30 days following vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diphtheria, Tetanus and PertussisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 556 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, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583049
- Sponsor's protocol ID
- CVX01E
- Status last verified
- Sep 2017
- First submitted
- 20 Apr 2012
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Post Authorisation Safety Study to Describe the Safety Profile of the Diphtheria, Tetanus, Acellular Pertussis Combination Vaccine, Reduced Antigen Content (Triaxis) as a 5th Dose in 4-6 Year Old Spanish Children
- ClinicalTrials.gov ID
- NCT01583049
- Acronym / sponsor ID
- CVX01E
- Conditions
- Diphtheria, Tetanus and Pertussis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2012 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Apr 2012 (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.
Primary objective: This is a descriptive study and the primary objective is to determine the incidence of injection site and systemic adverse events after Triaxis administration as a 5th dose of tetanus, diphtheria and acellular pertussis vaccine in 4-6 year old children
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children between 4-6 years of age who attend the investigator's office to receive a 5th dose of tetanus, diphtheria and pertussis Triaxis vaccine as part of the routine vaccination schedule, as described in the Spanish version of the EU SmPC and local vaccination calendar
Key inclusion criteria (5 listed)
- Aged 4 to 6 years on the day of enrolment.
- Have received, on the day of enrolment, immunisation with Triaxis as a 5th dose for diphtheria, tetanus, pertussis vaccination in routine practice in accordance with the Spanish version of the EU SmPC and the Spanish immunisation recommendations.
- Have received a complete course of immunisation with diphtheria, tetanus and pertussis (4 doses).
- Participant and participant´s parent/legal representative are able to comply with all study procedures.
- Written informed consent obtained from at least one parent/legal representative of the participant before the participant is enrolled in the study
Key exclusion criteria (6 listed)
- Have been previously vaccinated with a 5th dose of tetanus, diphtheria and pertussis.
- Presence of a contra-indication or cautions to vaccination in accordance with the Spanish version of the EU SmPC:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All Injection Site and Systemic Adverse Events
Time frame: 30 days following 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 11 Sep 2017.
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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, a Sanofi Company
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diphtheria, Tetanus and Pertussis, run by Sanofi Pasteur, a Sanofi Company at 22 sites in Spain.
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 5 inclusion and 6 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain. 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.
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?
All Injection Site and Systemic Adverse Events (time frame: 30 days following 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 11 Sep 2017.