Post Authorisation Safety Study of Triaxis as a 5th Dose in 4-6 Year Old Spanish Children
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
1 other identifier
observational
556
1 country
22
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Shorter than P25 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 20, 2012
CompletedFirst Posted
Study publicly available on registry
April 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedSeptember 11, 2017
September 1, 2017
5 months
April 20, 2012
September 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
All Injection Site and Systemic Adverse Events
30 days following vaccination
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Centre 11
Almería, Spain
Centre 12
Almería, Spain
Centre 13
Almería, Spain
Centre 14
Almería, Spain
Centre 15
Almería, Spain
Centre 16
Almería, Spain
Centre 17
Almería, Spain
Centre 18
Almería, Spain
Centre 19
Almería, Spain
Centre 20
Almería, Spain
Centre 21
Almería, Spain
Centre 22
Almería, Spain
Centre 10
Madrid, Spain
Centre 1
Madrid, Spain
Centre 2
Madrid, Spain
Centre 3
Madrid, Spain
Centre 4
Madrid, Spain
Centre 5
Madrid, Spain
Centre 6
Madrid, Spain
Centre 7
Madrid, Spain
Centre 8
Madrid, Spain
Centre 9
Madrid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur, a Sanofi Company
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2012
First Posted
April 23, 2012
Study Start
March 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
September 11, 2017
Record last verified: 2017-09