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
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
2 other identifiers
interventional
450
1 country
1
Brief Summary
The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 19, 2009
CompletedFirst Posted
Study publicly available on registry
February 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedMay 9, 2016
May 1, 2016
6 months
February 19, 2009
May 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
21 days
Secondary Outcomes (1)
Strain-specific influenza antibody titers will be used to assess Immunogenicity
21 days
Study Arms (10)
1
ACTIVE COMPARATOR2
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ACTIVE COMPARATORInterventions
1 dose of Trivalent Influenza Vaccine with high A content
1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant
1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant
1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant
1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant
1 dose of Trivalent Influenza Vaccine plus adjuvant
1 dose of Trivalent Influenza Vaccine with high A plus adjuvant
1 dose of Trivalent Influenza Vaccine intradermal dose
1 intradermal dose of Trivalent Influenza Vaccine + high A
Eligibility Criteria
You may qualify if:
- Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seqiruslead
- Novartis Vaccinescollaborator
Study Sites (1)
Center For Vaccinology
Ghent, 9000, Belgium
Related Publications (2)
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.
PMID: 24732325DERIVEDDella 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.
PMID: 22426371DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2009
First Posted
February 20, 2009
Study Start
October 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
May 9, 2016
Record last verified: 2016-05