Post Authorisation Safety Study of Triaxis as a 5th Dose in 4-6 Year Old Spanish Children
Information source: Sanofi Pasteur MSD
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diphtheria,; Tetanus and Pertussis
Phase: N/A
Status: Completed
Sponsored by: Sanofi Pasteur MSD
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
Clinical Details
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
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: all injection site and systemic Adverse Events
Eligibility
Minimum age: 4 Years.
Maximum age: 6 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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:
1. 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.
2. Encephalopathy of unknown origin within 7 days after a prior immunisation with a
vaccine against pertussis.
3. Progressive neurological disorder, uncontrolled epilepsy, progressive
encephalopathy if no treatment has been established and the condition is not
stable.
4. Acute severe febrile illness or acute infection.
Locations and Contacts
Centre 11, Almeria, Spain
Centre 12, Almeria, Spain
Centre 13, Almeria, Spain
Centre 14, Almeria, Spain
Centre 15, Almeria, Spain
Centre 16, Almeria, Spain
Centre 17, Almeria, Spain
Centre 18, Almeria, Spain
Centre 19, Almeria, Spain
Centre 20, Almeria, Spain
Centre 21, Almeria, Spain
Centre 22, Almeria, Spain
Centre 1, Madrid, Spain
Centre 10, 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
Additional Information
Starting date: March 2012
Last updated: August 3, 2012
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