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

This study has been completed.
Sponsor:
Collaborators:
Oxon Epidemiology/ Chiltern
Dr. José Garcia Sicilia-López
Dr. Francisco Giménez
SanofiPasteur
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01583049
First received: April 20, 2012
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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
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 Pasteur MSD:

Primary Outcome Measures:
  • all injection site and systemic Adverse Events [ Time Frame: for 30 days following vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 556
Study Start Date: March 2012
Study Completion Date: August 2012
  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
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

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.
  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 ClinicalTrials.gov identifier: NCT01583049

Locations
Spain
Centre 11
Almeria, Spain
Centre 22
Almeria, Spain
Centre 13
Almeria, Spain
Centre 14
Almeria, Spain
Centre 15
Almeria, Spain
Centre 21
Almeria, Spain
Centre 17
Almeria, Spain
Centre 18
Almeria, Spain
Centre 19
Almeria, Spain
Centre 20
Almeria, Spain
Centre 16
Almeria, Spain
Centre 12
Almeria, Spain
Centre 3
Madrid, Spain
Centre 4
Madrid, Spain
Centre 5
Madrid, Spain
Centre 6
Madrid, Spain
Centre 2
Madrid, Spain
Centre 7
Madrid, Spain
Centre 9
Madrid, Spain
Centre 10
Madrid, Spain
Centre 1
Madrid, Spain
Centre 8
Madrid, Spain
Sponsors and Collaborators
Sanofi Pasteur MSD
Oxon Epidemiology/ Chiltern
Dr. José Garcia Sicilia-López
Dr. Francisco Giménez
SanofiPasteur
  More Information

No publications provided

Responsible Party: Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT01583049     History of Changes
Other Study ID Numbers: CVX01E
Study First Received: April 20, 2012
Last Updated: August 3, 2012
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014