Immunization standards

Joint review of clinical trial application for conjugate Meningitis A vaccine
6-8 June 2007 in Dakar, Senegal

MVP plans to start phase II/III clinical trials of Conjugate Meningitis A vaccine manufactured by the Serum Institute of India (SII) in The Gambia, Mali and Senegal. IVB/QSS Regulatory Pathways has liaised with MVP to coordinate a joint review of the clinical trial application (CTA) involving the three countries and other countries where phase III trials will be conducted in 2007/8 as a capacity building activity (Burkina Faso, Ghana). Niger was also invited since demonstration studies are planned in that country but there was no representation (person nominated cancelled last minute), and NRA and Ethics Committee from Mali did not attend. The review group formulated questions for the representative of MVP, Dr Simonetta Viviani, and the Principal Investigators from the Malian and Senegalese sites, who attended the consultation session on Friday June 8. Some of the questions were answered ad hoc and for some, MVP will submit additional information to the National Regulatory Authorities (NRAs) of The Gambia, Senegal and Mali.

The participants have reported that this activity was extremely helpful and an excellent learning experience. Ethics Committee and NRA of Senegal need to continue discussions to find a way to coordinate and exchange the outcomes of their reviews. The review was done under the guidance from Dr Daniel Chandramohan from the London School of Tropical Medicine and Hygiene. A report including all the questions prepared by the reviewers, answers from MVP and action points for further submissions by MVP was prepared in English and French. A copy will be sent to the NRA from Mali to assist them with their regulatory process for the authorization of the clinical trial. Each NRA will communicate officially to MVP the outcome of this review, and will finalize the process upon submission of requested information.