Post Authorisation Safety Study of Triaxis as a 5th Dose in 4-6 Year Old Spanish Children
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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
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
Actual Study Start Date
Primary Completion Date
Study Completion Date
Resource links provided by the National Library of Medicine
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, Learn About Clinical Studies.
Ages Eligible for Study:
4 Years to 6 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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:
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.
Encephalopathy of unknown origin within 7 days after a prior immunisation with a vaccine against pertussis.
Progressive neurological disorder, uncontrolled epilepsy, progressive encephalopathy if no treatment has been established and the condition is not stable.