NCT01773928

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

Randomized, Age-stratified, Double Blind, Controlled Phase 3 Study Comparing a Vero Cell-derived Trivalent Seasonal Influenza Vaccine Made by the Modified Manufacturing Process With Vaccine Made by the Current Manufacturing Process and a Licensed Trivalent Influenza Vaccine in Healthy Adults Aged 18 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,928 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
BIOLOGICAL	VCIV manufactured with the current manufacturing process (VCIV current)
BIOLOGICAL	Fluzone®, licensed trivalent influenza vaccine (TIV)

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2013-01-23
• Last updated: 2025-09-11
• Results posted: 2025-09-11

Locations

20 sites across 1 country: United States