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

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01583049
Collaborator
(none)
556
Enrollment
22
Locations
5
Actual Duration (Months)
25.3
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    556 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Mar 1, 2012
    Actual Primary Completion Date :
    Aug 1, 2012
    Actual Study Completion Date :
    Aug 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. All Injection Site and Systemic Adverse Events [30 days following vaccination]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre 11 Almeria Spain
    2 Centre 12 Almeria Spain
    3 Centre 13 Almeria Spain
    4 Centre 14 Almeria Spain
    5 Centre 15 Almeria Spain
    6 Centre 16 Almeria Spain
    7 Centre 17 Almeria Spain
    8 Centre 18 Almeria Spain
    9 Centre 19 Almeria Spain
    10 Centre 20 Almeria Spain
    11 Centre 21 Almeria Spain
    12 Centre 22 Almeria Spain
    13 Centre 10 Madrid Spain
    14 Centre 1 Madrid Spain
    15 Centre 2 Madrid Spain
    16 Centre 3 Madrid Spain
    17 Centre 4 Madrid Spain
    18 Centre 5 Madrid Spain
    19 Centre 6 Madrid Spain
    20 Centre 7 Madrid Spain
    21 Centre 8 Madrid Spain
    22 Centre 9 Madrid Spain

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    • Study Director: Medical Director, Sanofi Pasteur, a Sanofi Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT01583049
    Other Study ID Numbers:
    • CVX01E
    First Posted:
    Apr 23, 2012
    Last Update Posted:
    Sep 11, 2017
    Last Verified:
    Sep 1, 2017
    Additional relevant MeSH terms:
    Whooping Cough
    Tetanus
    Diphtheria

    Study Results

    No Results Posted as of Sep 11, 2017