Vaccines have contributed to significantly reducing the prevalence of many childhood infectious diseases, such as diphtheria or measles, and some of these have been eradicated in Spain (for example, polio) thanks to effective vaccination campaigns. Most vaccines are given to healthy babies, children, and adolescents. Therefore, it is of vital importance to demonstrate that vaccines are safe and effective. Ensuring their safety and efficacy is one of the priorities of drug regulatory agencies.
If too many people choose not to get vaccinated or to not vaccinate their children, some rare or non-existent diseases may return.
A vaccine is a medicinal product. Like any medicinal product, vaccines have risks and benefits, and although they are very effective, none offer 100% protection against disease or are 100% safe for everyone. Most of the side effects are mild and brief.
To be sure of the efficacy and safety of vaccines in children and young people, it is essential to carry out clinical trials in these age groups that provide us with scientific evidence.
The Clinical Research Unit of SJD Hospital Barcelona has extensive experience in paediatric clinical trials, being the leading unit in Spain in paediatric clinical trials, thanks to the cooperation of patients and families.
Participation in clinical trials of paediatric vaccines
In the majority of clinical trials on vaccines, healthy children and young volunteers who are not suffering from any relevant underlying disease participate. If the vaccine is approved in the healthy child, in most cases, the indication is extended to the patient with an underlying disease if there are no contraindications.
Vaccine clinical trials are usually short in time and involve very close monitoring of the patient. In addition to the administration of the vaccine, blood tests should be performed, as a minimum before and after vaccination, and with the additional regularity required by the clinical trial.
It is always mandatory for the parents or legal guardians of the child or young person to sign the informed consent form. In addition, adolescents over 12 years of age must express their approval by signing a document known as informed assent.
In these documents, the patient and his/her family are informed of the reasons for conducting the clinical trial, for which his/her participation is voluntary, the procedures which are going to be performed and for how long, and the possible risks and benefits of participating in the study.
Children and young people are a very active and essential part of the scientific advance for the diagnosis and treatment of paediatric diseases, and also in clinical trials of vaccines. Since 2015, SJD Hospital Barcelona has promoted the Kids Barcelona programme, a group of children and young people who advise us and give children and their families a voice in the medicine, research and innovation that we carry out, and of course, in clinical trials.
Do you want to participate in one of our clinical trials?
If you are interested in knowing more about vaccines and the clinical trials on vaccines that are carried out at the SJD Hospital, you can check which studies need participants and sign up on the website of the Sant Joan de Déu Research Institute (IRSJD). Information in Spanish.
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