Proposed single development plan for tetanus-diphtheria-pertussis vaccines is released for public consultation

The European Medicines Agency is proposing a single development plan that pharmaceutical companies should follow when developing new vaccines to protect children against diphtheria, tetanus and acellular pertussis (whooping cough) across the European Union (EU). The proposal aims to harmonise the way these vaccines are being developed in order to avoid the duplication of similar clinical trials and the unnecessary exposure of children to clinical testing.

Childhood vaccination programmes against diphtheria, tetanus and acellular pertussis are used routinely across the EU and have resulted in the successful control of these three infectious diseases. As the 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 Paediatric Committee (PDCO) and Committee for Medicinal Products for Human Use (CHMP), in collaboration with the European Centre for Disease Prevention and Control (ECDC), have now defined a single schedule for clinical trials in children that would produce data relevant to the various vaccination schedules in individual European Member States.

While defining this single schedule for clinical trials, the EMA and ECDC have consulted a panel of public health vaccinology experts who have endorsed the proposal.

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

The proposed paediatric investigation plan has been released for a three-month public consultation. Comments should be sent to by 19 December 2014 using the form provided.


Posted on the EMA website on 23 September 2014