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

Diphtheria, Tetanus and Pertussis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583049
• Other study ID #: CVX01E
• Status: Completed
• Phase: N/A
• First received: April 20, 2012
• Last updated: September 8, 2017
• Start date: March 2012
• Est. completion date: August 2012

Study information

• Verified date: September 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diphtheria
• Diphtheria, Tetanus and Pertussis
• Tetanus
• Whooping Cough

Locations

Country	Name	City	State
Spain	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 1	Madrid
Spain	Centre 10	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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Injection Site and Systemic Adverse Events		30 days following vaccination