Clinical trial NCT01583049: Post Authorisation Safety Study of Triaxis as a 5th Dose in 4-6 Year Old Spanish Children
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diphtheria, Tetanus and Pertussis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-04-23
Enrollment: 556
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility 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.

Primary outcomes:
measure: All Injection Site and Systemic Adverse Events
timeFrame: 30 days following vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: Centre 11
city: Almeria
country: Spain
facility: Centre 12
city: Almeria
country: Spain
facility: Centre 13
city: Almeria
country: Spain
facility: Centre 14
city: Almeria
country: Spain
facility: Centre 15
city: Almeria
country: Spain
facility: Centre 16
city: Almeria
country: Spain
facility: Centre 17
city: Almeria
country: Spain
facility: Centre 18
city: Almeria
country: Spain
facility: Centre 19
city: Almeria
country: Spain
facility: Centre 20
city: Almeria
country: Spain
facility: Centre 21
city: Almeria
country: Spain
facility: Centre 22
city: Madrid
country: Spain
facility: Centre 10
city: Madrid
country: Spain
facility: Centre 1
city: Madrid
country: Spain
facility: Centre 2
city: Madrid
country: Spain
facility: Centre 3
city: Madrid
country: Spain
facility: Centre 4
city: Madrid
country: Spain
facility: Centre 5
city: Madrid
country: Spain
facility: Centre 6
city: Madrid
country: Spain
facility: Centre 7
city: Madrid
country: Spain
facility: Centre 8
city: Madrid
country: Spain
facility: Centre 9
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References: