drugset / Trial / NCT03158038

Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season

NCT03158038 ↗

Phase 4 Completed 300 enrolled MedImmune LLC AstraZeneca · collab
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza season.

Timeline

Start
2017-05-30
Primary completion
2017-12-14
Completion
2017-12-14

Outcome

Missed primary endpoint

registry analysis (superiority test); Monovalent Influenza Vaccine vs Placebo; Rate difference 0 (95% CI -6.7 to 1.9) NCT03158038 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Monovalent Influenza Vaccine Vaccine 1e+07 unknown Intranasal

Indications