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Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived)

NCT00424086 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2015-10-09

No results posted yet for this study

Summary

The objective of this study is to assess the safety, tolerability and immunogenicity of a Split Virus, Vero Cell derived, Seasonal Influenza Vaccine (VCIV) in comparison to a Licensed Egg Derived, Split Virus, Seasonal Influenza Vaccine (EIV) in healthy subjects 18 years of age and older.

Approximately 1000 subjects will be randomly assigned in a 3:1 ratio to receive a single injection of VCIV or EIV. Subjects will be monitored for 180 days following vaccination for occurrence of adverse reactions and for antibody response to the vaccine.

Conditions

Interventions

BIOLOGICAL

Inactivated seasonal influenza vaccine (split virus, vero cell derived)

BIOLOGICAL

Inactivated seasonal influenza vaccine (split virus, egg derived) [licensed control vaccine]

Sponsors & Collaborators

  • Alachua Government Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Baxter BioScience Investigator · Baxter Healthcare Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Completion
2007-09-30

Countries

  • Austria
  • Germany
  • Poland

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 NCT00424086 on ClinicalTrials.gov