EMA opens public consultation on proposition to avoid duplicating clinical trials in children

The European Medicines Agency is proposing a new development plan that would avoid the duplication of clinical trials and the unnecessary exposure of children to clinical testing for diphtheria, tetanus and whooping cough.

Its proposal, open for public consultation, aims to harmonize the trial phase of drug development in these illnesses. Since schedules of child vaccinations vary slightly between countries, a large number of fairly similar clinical trials are conducted in children when a new vaccine is being developed. The EMA’s pediatric committee, the Committee for Medicinal Products for Human Use and the European Center for Disease Prevention and Control have defined a single schedule for clinical trials in children that would produce data relevant to the differing vaccination schedules in individual European member states.

The schedule would consist of two priming doses and two and four months of age, with a booster dose at 12 months, and further studies may be required if the vaccines are given together with another vaccine such as meningococcal or rotavirus.