Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal

Phase 3 Completed 1761 enrolled PATH Centers for Disease Control and Prevention · collab Institut Pasteur de Dakar · collab Institut de Recherche pour le Developpement · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study will provide the Senegal Ministry of Health with data on the clinical efficacy of the Live-Attenuated Influenza Vaccine (LAIV). This data will inform future policy considerations for influenza vaccine.

Timeline

Start: 2013-05
Primary completion: 2013-12
Completion: 2013-12

Outcome

Missed primary endpoint

registry NUMBER Vaccine: 17.9 percentage of participants NUMBER Placebo: 18.0 percentage of participants analysis (superiority or other test); Vaccine vs Placebo; p = 0.996; Log Rank NCT01854632 ↗

paper giving a vaccine efficacy of 0·0% (95% CI -26·4 to 20·9). PMID 27746224 ↗

Publications

Victor JC, Lewis KD, Diallo A, Niang MN, Diarra B, Dia N, Ortiz JR, Widdowson MA, Feser J, Hoagland R, Emery SL, Lafond KE, Neuzil KM. Efficacy of a Russian-backbone live attenuated influenza vaccine among children in Senegal: a randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2016 Dec;4(12):e955-e965. doi: 10.1016/S2214-109X(16)30201-7. Epub 2016 Oct 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SIIL Live Attenuated Influenza Vaccine	Vaccine	0.5 ml	Intranasal