drugset / Trial / NCT01773928

Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)

NCT01773928

Phase 3 Completed 1928 enrolled Alachua Government Services, Inc.
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process: 1. induces immune responses comparable to that produced by the current manufacturing process 2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine 3. demonstrates consistency of immune response among three different lots.

Timeline

Start
2013-01
Primary completion
2013-04
Completion
2013-04

Publications

  • Background StatXact 7 PROCs for SAS Users, Cytel Inc, Cambridge, 2005.

Drugs

EvaluationDrugModalityDoseRoute
Comparator Influenza Virus Vaccine Vaccine
Comparator VCIV current Unknown
Subject VCIV modified Vaccine

Indications