CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,928 enrolled
Drug / intervention
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01773928
NCT01773928Phase 3Completed

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

Alachua Government Services, Inc.·interventional·Posted Jan 23, 2013·Updated Sep 11, 2025

In Brief

A Phase 3 clinical trial evaluating Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified), VCIV manufactured with the current manufacturing process (VCIV current), and 1 other intervention for Influenza. Completed, enrolled 1,928 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 23, 2013
Enrollment StartJan 1, 2013
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.4 years ago

Interventions

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)biological