Immunogenicity and Safety Trial of Adjuvanted and Non-adjuvanted Trivalent Influenza Vaccine in Tropical Africa

Summary

This study will provide the Senegal Ministry of Health with data on the safety and immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children. This data will inform future policy considerations for influenza vaccine. The study is not powered to detect significant differences between vaccines or groups, and no hypotheses are to be tested; therefore, immunogenicity and safety objectives are to be analyzed descriptively.

Timeline

Start

2013-04

Primary completion

2013-09

Completion

2013-09

Publications

• Diallo A, Victor JC, Feser J, Ortiz JR, Kanesa-Thasan N, Ndiaye M, Diarra B, Cheikh S, Diene D, Ndiaye T, Ndiaye A, Lafond KE, Widdowson MA, Neuzil KM. Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naive children in a randomized clinical trial in rural Senegal. Vaccine. 2018 Oct 15;36(43):6424-6432. doi: 10.1016/j.vaccine.2018.08.032. Epub 2018 Sep 14.

Drugs

Indications