Background The immune system matures throughout childhood; therefore, evidence about the safety and efficacy of vaccines for the prevention of COVID-19 in the paediatric population is important. Efficacy and safety have not been established for COVID-19 vaccines in a large part of the paediatric population at the time of the initial approval for use in adults. This study aims to provide an overview of planned and ongoing paediatric clinical trials investigating the safety and/or efficacy of COVID-19. Methods We identified all paediatric clinical trials investigating the safety and/or efficacy of COVID-19 vaccines in clinicaltrials.gov and clinicaltrialregister.eu, as well as all clinical trials planned in agreed PIPs (Paediatric Investigational Plans) as of 11 June 2021. Information about the study design, the paediatric age groups that they included, and the primary and secondary safety and efficacy outcomes were collected, together with expected timelines for the studies. Results 21 clinical trials were identified through the clinical trial registries and 19 clinical trials were specified in 6 agreed PIPs, 5 of these trials were also in the trial registers. All PIPs stipulated development of the COVID-19 vaccines for the full paediatric population, with a deferral. The earliest expected completion date of a PIPs is March 2024. The majority (14/21) of registered trials are randomised double-blinded studies. All investigated safety, 20 have a surrogate efficacy outcome (immunogenicity), of these 7 also measure clinical efficacy (COVID-19 infections). 18 studies were initiated, of these, all but one is still ongoing and one in adolescents has been finalised. Conclusion Even though several trials have been planned in agreed PIPs, the registered paediatric clinical trials identified are most often not part of a PIP. Supplementary Information The online version contains supplementary material available at 10.1007/s43441-021-00356-y.
【저자키워드】 Drug development, COVID-19 vaccines, paediatric, Paediatric clinical trials, 【초록키워드】 COVID-19, Efficacy, Vaccine, COVID-19 vaccine, clinical trial, Trial, randomised, immune system, outcome, Adults, Study design, age, group, timeline, Evidence, Clinical efficacy, supplementary material, double-blinded, COVID-19 infections, Registered, approval, prevention of COVID-19, initial, Result, collected, investigated, majority, initiated, expected, clinical trial registry, PIP, 【제목키워드】 COVID-19, database, clinical, status, PIP,