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

Completed

• Conditions: Diphtheria, Tetanus and Pertussis

• Registration Number: NCT01583049
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-23
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 556

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All Injection Site and Systemic Adverse Events	30 days following vaccination

Trial Locations

Locations (22)

Centre 13; 🇪🇸 Almeria, Spain

Centre 18; 🇪🇸 Almeria, Spain

Centre 12; 🇪🇸 Almeria, Spain

Centre 15; 🇪🇸 Almeria, Spain

Centre 17; 🇪🇸 Almeria, Spain

Centre 20; 🇪🇸 Almeria, Spain

Centre 1; 🇪🇸 Madrid, Spain

Centre 2; 🇪🇸 Madrid, Spain

Centre 8; 🇪🇸 Madrid, Spain

Centre 11; 🇪🇸 Almeria, Spain

Centre 14; 🇪🇸 Almeria, Spain

Centre 16; 🇪🇸 Almeria, Spain

Centre 10; 🇪🇸 Madrid, Spain

Centre 19; 🇪🇸 Almeria, Spain

Centre 21; 🇪🇸 Almeria, Spain

Centre 22; 🇪🇸 Almeria, Spain

Centre 4; 🇪🇸 Madrid, Spain

Centre 5; 🇪🇸 Madrid, Spain

Centre 6; 🇪🇸 Madrid, Spain

Centre 7; 🇪🇸 Madrid, Spain

Centre 9; 🇪🇸 Madrid, Spain

Centre 3; 🇪🇸 Madrid, Spain