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Yearly Strain Variation Study, 2010/2011

Primary Purpose

Influenza, Seasonal Influenza

Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Inactivated influenza vaccine (split virus, Vero cell-derived)
Sponsored by
Ology Bioservices
About
Eligibility
Locations
Arms
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:

  • Subject is 18 to 59 years of age, inclusive, at the time of screening (for Stratum A only)
  • Subject is 60 years of age or older, inclusive, at the time of screening (for Stratum B only)
  • Subject has given written informed consent prior to study entry
  • Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice
  • Subject agrees to keep a daily record of symptoms for the duration of the study
  • If subject is of childbearing potential, subject presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
  • Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

  • Subject has a history of severe allergic reaction or anaphylaxis
  • Subject has an oral temperature of >= 37.5°C on the day of vaccination in this study.
  • Subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating
  • Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry
  • Subject has received a seasonal influenza vaccine within 6 months of study entry
  • Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
  • Subject has any inherited or acquired immunodeficiency
  • Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
  • Subject has a functional or surgical asplenia
  • Subject has a known or suspected problem with alcohol or drug abuse
  • Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study.
  • Subject is pregnant or lactating at the time of enrollment
  • Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study

Sites / Locations

  • University Clinic for Clinical Pharmacology, General Hospital Vienna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccine

Arm Description

Vaccination with one dose (0.5 mL) of inactivated influenza vaccine

Outcomes

Primary Outcome Measures

To assess the immunogenicity to each of the three antigens contained in a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2010/2011 season in an adult and elderly population

Secondary Outcome Measures

Full Information

First Posted
July 6, 2010
Last Updated
October 19, 2020
Sponsor
Ology Bioservices
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1. Study Identification

Unique Protocol Identification Number
NCT01157702
Brief Title
Yearly Strain Variation Study, 2010/2011
Official Title
An Open-Label Phase 3 Study to Assess the Immunogenicity and Safety of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2010/2011, in an Adult and Elderly Population
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ology Bioservices

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2010/2011 season for yearly licensing application.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine
Arm Type
Experimental
Arm Description
Vaccination with one dose (0.5 mL) of inactivated influenza vaccine
Intervention Type
Biological
Intervention Name(s)
Inactivated influenza vaccine (split virus, Vero cell-derived)
Other Intervention Name(s)
Preflucel
Intervention Description
One 0.5 mL dose of inactivated influenza vaccine in a pre-filled syringe, administered by intramuscular injection into the musculus deltoideus in the upper arm
Primary Outcome Measure Information:
Title
To assess the immunogenicity to each of the three antigens contained in a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2010/2011 season in an adult and elderly population
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject is 18 to 59 years of age, inclusive, at the time of screening (for Stratum A only) Subject is 60 years of age or older, inclusive, at the time of screening (for Stratum B only) Subject has given written informed consent prior to study entry Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice Subject agrees to keep a daily record of symptoms for the duration of the study If subject is of childbearing potential, subject presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study Subject is willing and able to comply with the requirements of the protocol Exclusion Criteria: Subject has a history of severe allergic reaction or anaphylaxis Subject has an oral temperature of >= 37.5°C on the day of vaccination in this study. Subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry Subject has received a seasonal influenza vaccine within 6 months of study entry Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder Subject has any inherited or acquired immunodeficiency Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs. Subject has a functional or surgical asplenia Subject has a known or suspected problem with alcohol or drug abuse Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study. Subject is pregnant or lactating at the time of enrollment Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
Facility Information:
Facility Name
University Clinic for Clinical Pharmacology, General Hospital Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Yearly Strain Variation Study, 2010/2011

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