Back to resultsAnnual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 Season
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trivalent influenza subunit vaccine Influvac
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccine, CHMP criteria
Eligibility Criteria
Inclusion Criteria
- Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- Men and women aged >= 18 and <= 60 years or >= 61 years of age at the day of study vaccination.
- Being in good health as judged by medical history, physical examination and clinical judgment of the investigator
Exclusion Criteria
- Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
- A serious adverse reaction after a previous (influenza) vaccination.
- Presence of any significant condition that may prohibit inclusion as determined by the investigator.
- Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
- A history of Guillain-Barré syndrome or active neurological disease
Sites / Locations
- Site Reference ID/Investigator# 44974
- Site Reference ID/Investigator# 44975
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines
HI titers and its derived parameters after 3 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines
Secondary Outcome Measures
Full Information
NCT ID
NCT01146015
First Posted
June 14, 2010
Last Updated
August 24, 2011
Sponsor
Abbott Biologicals
Collaborators
Quintiles, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01146015
Brief Title
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 Season
Official Title
Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2010/2011. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects and Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Biologicals
Collaborators
Quintiles, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of subjects in good health: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Vaccine, CHMP criteria
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Trivalent influenza subunit vaccine Influvac
Intervention Description
3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1
Primary Outcome Measure Information:
Title
HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines
Time Frame
2 weeks
Title
HI titers and its derived parameters after 3 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Willing and able to give informed consent and able to adhere to all protocol required study procedures.
Men and women aged >= 18 and <= 60 years or >= 61 years of age at the day of study vaccination.
Being in good health as judged by medical history, physical examination and clinical judgment of the investigator
Exclusion Criteria
Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
A serious adverse reaction after a previous (influenza) vaccination.
Presence of any significant condition that may prohibit inclusion as determined by the investigator.
Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
A history of Guillain-Barré syndrome or active neurological disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanka de Voogd, MD
Organizational Affiliation
Abbott Healthcare Products B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 44974
City
Tessenderlo
ZIP/Postal Code
3890
Country
Belgium
Facility Name
Site Reference ID/Investigator# 44975
City
Hamburg
ZIP/Postal Code
22769
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 Season
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