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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01583049

Enrollment

556

Registered

2012-04-23

Start date

2012-03-31

Completion date

2012-08-31

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diphtheria, Tetanus and Pertussis

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 6 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
All Injection Site and Systemic Adverse Events	30 days following vaccination

Countries

Spain

Outcome results