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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

Page last updated: August 20, 2015

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