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Comparison of the Safety and Immune Response of Three Different Lots of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2004/2005

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vero Cell-derived Influenza Vaccine
Egg cell-derived Influenza 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 - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male and female subjects will be eligible for participation in this study if they: are >= 18 and <= 60 years old on the day of screening (for Stratum A only); are > 60 years old on the day of screening (for Stratum B only); 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); will reliably keep a daily record of symptoms; understand the nature of the study, agree to its provisions, and give written informed consent; if female and capable of bearing children - have a negative pregnancy test (urine) result at study entry and agree to employ adequate birth control measures for the duration of the study. Exclusion Criteria: Subjects will be excluded from participation in this study if they: have received any influenza vaccine for the 2003/2004 season and/or for the 2004/2005 season; 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, chemotherapeutics) that can be expected to influence the normal immunologic functions; 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 or other known contraindications); have a rash or dermatological condition which may interfere with injection site reaction rating; have a known or suspected problem with drug or alcohol abuse; are unable to lead an independent life either physically or mentally; were administered an investigational drug within six weeks prior to study entry; are concurrently participating in a clinical study including the administration of an investigational product; if female, are pregnant or lactating.

Sites / Locations

  • Vienna General Hospital (AKH), Department of Clinical Pharmacology
  • Neuendorfstr. 20
  • Münstererstr. 1a
  • Mainz University Children´s Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
October 7, 2015
Sponsor
Ology Bioservices
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1. Study Identification

Unique Protocol Identification Number
NCT00161811
Brief Title
Comparison of the Safety and Immune Response of Three Different Lots of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2004/2005
Official Title
Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety After a Single Vaccination With Three Different Lots of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell-derived) in Comparison to a Licensed Egg Derived Influenza Vaccine for Season 2004/2005.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ology Bioservices

4. Oversight

5. Study Description

Brief Summary
The objectives of the study are to assess the immunogenicity and safety among three different lots of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after 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 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Vero Cell-derived Influenza Vaccine
Intervention Type
Biological
Intervention Name(s)
Egg cell-derived Influenza Vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female subjects will be eligible for participation in this study if they: are >= 18 and <= 60 years old on the day of screening (for Stratum A only); are > 60 years old on the day of screening (for Stratum B only); 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); will reliably keep a daily record of symptoms; understand the nature of the study, agree to its provisions, and give written informed consent; if female and capable of bearing children - have a negative pregnancy test (urine) result at study entry and agree to employ adequate birth control measures for the duration of the study. Exclusion Criteria: Subjects will be excluded from participation in this study if they: have received any influenza vaccine for the 2003/2004 season and/or for the 2004/2005 season; 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, chemotherapeutics) that can be expected to influence the normal immunologic functions; 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 or other known contraindications); have a rash or dermatological condition which may interfere with injection site reaction rating; have a known or suspected problem with drug or alcohol abuse; are unable to lead an independent life either physically or mentally; were administered an investigational drug within six weeks prior to study entry; are concurrently participating in a clinical study including the administration of an investigational product; if female, are pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Müller, MD
Organizational Affiliation
Vienna General Hospital (AKH), Department of Clinical Pharmacology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pirmin Habermehl, MD
Organizational Affiliation
Mainz University Children´s Clinic, Center for Clinical Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna General Hospital (AKH), Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Neuendorfstr. 20
City
Henningsdorf
ZIP/Postal Code
16761
Country
Germany
Facility Name
Münstererstr. 1a
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Mainz University Children´s Clinic
City
Mainz
ZIP/Postal Code
D-55101
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Safety and Immune Response of Three Different Lots of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2004/2005

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