Post Authorisation Safety Study of Triaxis as a 5th Dose in 4-6 Year Old Spanish Children

September 8, 2017 updated by: Sanofi Pasteur, a Sanofi Company

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

556

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almeria, Spain
        • 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
      • Madrid, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All Injection Site and Systemic Adverse Events
Time Frame: 30 days following vaccination
30 days following vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

April 20, 2012

First Posted (Estimate)

April 23, 2012

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVX01E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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