MedTrace Logo

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

NCT01773928 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1928

Last updated 2025-09-11

Study results available
· View outcomes & findings →

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

Interventions

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)

Sponsors & Collaborators

  • Alachua Government Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Nirjhar Chatterjee, MD · Baxter Healthcare Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01773928 on ClinicalTrials.gov