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

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company ) Identifier:
First received: April 20, 2012
Last updated: September 8, 2017
Last verified: September 2017
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

Diphtheria, Tetanus and Pertussis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

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

Enrollment: 556
Actual Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01583049

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
Study Director: Medical Director Sanofi Pasteur, a Sanofi Company
  More Information

Responsible Party: Sanofi Pasteur, a Sanofi Company Identifier: NCT01583049     History of Changes
Other Study ID Numbers: CVX01E
Study First Received: April 20, 2012
Last Updated: September 8, 2017

Additional relevant MeSH terms:
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 processed this record on September 20, 2017