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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00289510 |
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.
Condition | Intervention | Phase |
---|---|---|
Influenza |
Biological: Inactivated influenza vaccine (whole virion, Vero cell-derived) Biological: Inactivated influenza vaccine (egg derived) [licensed control vaccine] |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Single-Blind, Randomized, Controlled Phase I/II Study to Compare the Safety and Immunogenicity of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) With a License Egg Derived Influenza Vaccine |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male and female subjects who
Exclusion Criteria:
Subjects who
Austria | |
Allgemeines Krankenhaus Wien (General Hospital Vienna) | |
Vienna, Austria, 1090 | |
Germany | |
Klinikum Westend, Haus 18 | |
Berlin, Germany, 14050 | |
Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine) | |
Mainz, Germany, 55116 |
Principal Investigator: | Markus Müller, MD | Allgemeines Krankenhaus Wien (General Hospital Vienna) |
Principal Investigator: | Kasra Shakeri-Nejad, MD | Klinikum Westend, Berlin |
Principal Investigator: | Bernhard Schmitt, MD | Internistische Gemeinschaftspraxis (Group practice for internal medicine) Dr. Regner & Dr. Schmitt, Mainz |
Principal Investigator: | Alen Jambrecina, MD | MDS Pharma Services Germany GmbH, Hamburg |
Principal Investigator: | Stephan De la Motte, MD | Harrison Clinical Research / Clinical Unit, Munich |
Study ID Numbers: | 710501 |
Study First Received: | February 9, 2006 |
Last Updated: | October 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00289510 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut; Austria: Federal Ministry for Health and Women |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |