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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583049
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : September 11, 2017
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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
Diphtheria, Tetanus and Pertussis

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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 : March 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Primary Outcome Measures :
  1. All Injection Site and Systemic Adverse Events [ Time Frame: 30 days following vaccination ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01583049

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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 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
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
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Study Director: Medical Director Sanofi Pasteur, a Sanofi Company

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Responsible Party: Sanofi Pasteur, a Sanofi Company Identifier: NCT01583049     History of Changes
Other Study ID Numbers: CVX01E
First Posted: April 23, 2012    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
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Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections