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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Inactivated influenza vaccine (whole virion, Vero cell-derived)
Inactivated influenza vaccine (egg derived) [licensed control vaccine]
Sponsored by
Ology Bioservices
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male and female subjects who are 18 to 45 years of age, inclusive, on the day of screening; have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry; are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study); agree to keep a daily record of symptoms; if female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study. Exclusion Criteria: Subjects who have received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season; have received any vaccination within 2 weeks prior to vaccination in this study; suffer from any kind of immunodeficiency; suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immune response; have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis); have received a blood transfusion or immunoglobulins within 30 days of study entry; have donated blood or plasma within 30 days of study entry; have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications); have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating; have a known or suspected problem with alcohol or drug abuse; are unable to lead an independent life as a result of either physical or mental handicap; were administered an investigational drug within six weeks prior to study entry; are concurrently participating in a clinical study that includes the administration of an investigational product; if female, are pregnant or lactating; are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.

Sites / Locations

  • Allgemeines Krankenhaus Wien (General Hospital Vienna)
  • Klinikum Westend, Haus 18
  • Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 9, 2006
Last Updated
October 7, 2015
Sponsor
Ology Bioservices
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1. Study Identification

Unique Protocol Identification Number
NCT00289510
Brief Title
Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ology Bioservices

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
423 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Inactivated influenza vaccine (whole virion, Vero cell-derived)
Intervention Type
Biological
Intervention Name(s)
Inactivated influenza vaccine (egg derived) [licensed control vaccine]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female subjects who are 18 to 45 years of age, inclusive, on the day of screening; have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry; are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study); agree to keep a daily record of symptoms; if female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study. Exclusion Criteria: Subjects who have received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season; have received any vaccination within 2 weeks prior to vaccination in this study; suffer from any kind of immunodeficiency; suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immune response; have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis); have received a blood transfusion or immunoglobulins within 30 days of study entry; have donated blood or plasma within 30 days of study entry; have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications); have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating; have a known or suspected problem with alcohol or drug abuse; are unable to lead an independent life as a result of either physical or mental handicap; were administered an investigational drug within six weeks prior to study entry; are concurrently participating in a clinical study that includes the administration of an investigational product; if female, are pregnant or lactating; are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Müller, MD
Organizational Affiliation
Allgemeines Krankenhaus Wien (General Hospital Vienna)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kasra Shakeri-Nejad, MD
Organizational Affiliation
Klinikum Westend, Berlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernhard Schmitt, MD
Organizational Affiliation
Internistische Gemeinschaftspraxis (Group practice for internal medicine) Dr. Regner & Dr. Schmitt, Mainz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alen Jambrecina, MD
Organizational Affiliation
MDS Pharma Services Germany GmbH, Hamburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan De la Motte, MD
Organizational Affiliation
Harrison Clinical Research / Clinical Unit, Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allgemeines Krankenhaus Wien (General Hospital Vienna)
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinikum Westend, Haus 18
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine)
City
Mainz
ZIP/Postal Code
55116
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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