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Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived)

NCT00289510 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2015-10-09

No results posted yet for this study

Summary

The objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a single injection of whole virion, Vero cell derived or egg derived influenza vaccine on Day 0. Subjects will return to the study site for safety evaluation at predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn at predetermined intervals to measure their immunologic response to vaccination.

Conditions

Interventions

BIOLOGICAL

Inactivated influenza vaccine (whole virion, Vero cell-derived)

BIOLOGICAL

Inactivated influenza vaccine (egg derived) [licensed control vaccine]

Sponsors & Collaborators

  • Alachua Government Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Markus Müller, MD · Allgemeines Krankenhaus Wien (General Hospital Vienna)

  • Kasra Shakeri-Nejad, MD · Klinikum Westend, Berlin

  • Bernhard Schmitt, MD · Internistische Gemeinschaftspraxis (Group practice for internal medicine) Dr. Regner & Dr. Schmitt, Mainz

  • Alen Jambrecina, MD · MDS Pharma Services Germany GmbH, Hamburg

  • Stephan De la Motte, MD · Harrison Clinical Research / Clinical Unit, Munich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31

Countries

  • Austria
  • Germany

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 NCT00289510 on ClinicalTrials.gov