Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older
May 5, 2016 updated by: Seqirus
A Phase Ib, Multi-Center, Randomized, Observer-Blind, Proof of Concept, Dose- and Formulation-Ranging Study to Evaluate Safety, Tolerability, and Immunogenicity of One Dose of Trivalent Inactivated Influenza Vaccine in Different Presentations (Intramuscular and Intradermal Delivery), Dosages (Regular or Higher A/H3N2 Content) and Doses of Adjuvant Administered to Healthy Elderly Aged ≥ 65 Years
The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Biological: Trivalent Influenza Vaccine
- Biological: Trivalent Influenza Vaccine + high A
- Biological: Trivalent Influenza Vaccine + ¼ dose adjuvant
- Biological: Trivalent Influenza Vaccine + high A + ¼ dose adjuvant
- Biological: Trivalent Influenza Vaccine + ½ dose adjuvant
- Biological: Trivalent Influenza Vaccine + high A + ½ dose adjuvant
- Biological: Trivalent Influenza Vaccine + adjuvant
- Biological: Trivalent Influenza Vaccine + high A + adjuvant
- Biological: Trivalent Influenza Vaccine intradermal dose
- Biological: Trivalent Influenza Vaccine + high A intradermal dose
Study Type
Interventional
Enrollment (Actual)
450
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ghent, Belgium, 9000
- Center for Vaccinology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator.
Exclusion Criteria:
- Subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted vaccine in the past two years.
- Subjects with hypersensitivity to vaccine components. Subjects who are on or were recently on immunosuppressive therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 2
|
1 dose of Trivalent Influenza Vaccine with high A content
|
|
Active Comparator: 1
|
1 dose of Trivalent Influenza Vaccine
|
|
Active Comparator: 3
|
1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant
|
|
Active Comparator: 4
|
1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant
|
|
Active Comparator: 5
|
1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant
|
|
Active Comparator: 7
|
1 dose of Trivalent Influenza Vaccine plus adjuvant
|
|
Active Comparator: 8
|
1 dose of Trivalent Influenza Vaccine with high A plus adjuvant
|
|
Active Comparator: 6
|
1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant
|
|
Active Comparator: 9
|
1 dose of Trivalent Influenza Vaccine intradermal dose
|
|
Active Comparator: 10
|
1 intradermal dose of Trivalent Influenza Vaccine + high A
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
Time Frame: 21 days
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Strain-specific influenza antibody titers will be used to assess Immunogenicity
Time Frame: 21 days
|
21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli C, Groth N, Levin Y, Del Giudice G. A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59(R)-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration. Hum Vaccin Immunother. 2014;10(6):1701-10. doi: 10.4161/hv.28618. Epub 2014 Apr 14.
- Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli G, Groth N, Del Giudice G. Superior immunogenicity of seasonal influenza vaccines containing full dose of MF59 ((R)) adjuvant: results from a dose-finding clinical trial in older adults. Hum Vaccin Immunother. 2012 Feb;8(2):216-27. doi: 10.4161/hv.18445. Epub 2012 Feb 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
February 19, 2009
First Submitted That Met QC Criteria
February 19, 2009
First Posted (Estimate)
February 20, 2009
Study Record Updates
Last Update Posted (Estimate)
May 9, 2016
Last Update Submitted That Met QC Criteria
May 5, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- V104P3
- 2008-002625-36
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.