This pediatric clinical trial aims to test the safety, tolerability and immunogenicity of Pfizer’s COVID vaccine in children under 12 years of age
Obtain the necessary information to complete the technical data sheet of these vaccines and to have all the safety rigour on how they work so that, if necessary, the paediatric population can be vaccinated with the same guarantees as adults. »
Description of Study:
- Title: Pediatric clinical trial of Pfizer’s COVID vaccine in children under 12 years of age.
- Principal Investigador: Federico Martinón Torres.
- Centres of implementation: Global clinical trial involving the Hospital Clínico Universitario de Santiago.
- Study population: Children under 12 years of age will participate. The clinical trial at the Hospital Clínico Universitario de Santiago will involve 55 healthy children who will take part in the global study, which is expected to include 4,644 young people, 557 of them in Spain.
- Type of study: Double-blind clinical trial.
- Methods: Participants will receive an injection approximately 3 weeks apart and those receiving placebo (one third) will have the opportunity to receive the vaccine within the study. Follow-up visits are scheduled and there will be a two-year follow-up period for each child.
Objectives of the Study:
Principal Objective: To evaluate the safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in the prevention of COVID-19 in healthy children under 12 years of age.
More about this Study:
The Complejo Hospitalario Universitario de Santiago de Compostela belongs to the Galician network of public use of the Galician Health Service and brings together the four hospitals located in Santiago de Compostela: Hospital Clínico Universitario, Hospital Médico Quirúrgico de Conxo, Hospital Gil Casares and Hospital Psiquiátrico de Conxo.
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