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Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Vero Cell-derived Influenza Vaccine
Egg-derived Influenza Vaccine
Sponsored by
Ology Bioservices
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccine

Eligibility Criteria

16 Years - undefined (Child, 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 (for Stratum A only); are > 60 years old (for Stratum B only); are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial; 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 - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study. Exclusion Criteria: Male and female subjects will be excluded from participation in this study if they: have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 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 immunological functions; have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis); have received a blood transfusion or immunoglobulins within one month of study entry; have a history of any vaccine-related contraindicating event (e.g. anaphylaxis); 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; had administration of an investigational drug within six weeks prior to the study start; are concurrently participating in a clinical trial; are pregnant or lactating.

Sites / Locations

  • PANTAMED Sp.z o.o.

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
NCT00161837
Brief Title
Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004
Official Title
Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) in Comparison to a Licensed Egg-derived Influenza Vaccine for Season 2003/2004
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (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 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
Keywords
Influenza, Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 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 (for Stratum A only); are > 60 years old (for Stratum B only); are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial; 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 - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study. Exclusion Criteria: Male and female subjects will be excluded from participation in this study if they: have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 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 immunological functions; have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis); have received a blood transfusion or immunoglobulins within one month of study entry; have a history of any vaccine-related contraindicating event (e.g. anaphylaxis); 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; had administration of an investigational drug within six weeks prior to the study start; are concurrently participating in a clinical trial; are pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerzy Romaszko, MD
Organizational Affiliation
PANTAMED sp. z o o.
Official's Role
Principal Investigator
Facility Information:
Facility Name
PANTAMED Sp.z o.o.
City
Olsztyn
ZIP/Postal Code
PL-10-461
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004

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