Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
179 participants
INTERVENTIONAL
2016-09-30
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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High Dose Influenza Vaccine
This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
High Dose Influenza vaccine
Licensed and FDA approved Fluzone HD vaccine to be administered to study participants
Adjuvanted Influenza Vaccine
This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
Adjuvanted Influenza vaccine
Licensed and FDA approved FluAd vaccine to be administered to study participants
Standard Dose Influenza Vaccine+HD
This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study.
High Dose Influenza vaccine
Licensed and FDA approved Fluzone HD vaccine to be administered to study participants
Standard Dose Influenza vaccine
Licensed and FDA approved Fluvirin vaccine to be administered to study participants
Standard Dose Influenza Vaccine +Adj
This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.
Adjuvanted Influenza vaccine
Licensed and FDA approved FluAd vaccine to be administered to study participants
Standard Dose Influenza vaccine
Licensed and FDA approved Fluvirin vaccine to be administered to study participants
Standard Dose Influenza Vaccine+Recomb
This group will be administered a standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.
Standard Dose Influenza vaccine
Licensed and FDA approved Fluvirin vaccine to be administered to study participants
Recombinant Influenza vaccine
Licensed and FDA approved FluBlok vaccine to be administered to study participants
Interventions
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High Dose Influenza vaccine
Licensed and FDA approved Fluzone HD vaccine to be administered to study participants
Adjuvanted Influenza vaccine
Licensed and FDA approved FluAd vaccine to be administered to study participants
Standard Dose Influenza vaccine
Licensed and FDA approved Fluvirin vaccine to be administered to study participants
Recombinant Influenza vaccine
Licensed and FDA approved FluBlok vaccine to be administered to study participants
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to give informed consent prior to study enrollment
* Able to comply with study requirements.
Exclusion Criteria
* Current participation in another clinical trial
* Presence of a contraindication to influenza vaccine
65 Years
74 Years
ALL
No
Sponsors
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Centers for Disease Control and Prevention
FED
Marshfield Clinic Research Foundation
OTHER
Responsible Party
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Huong McLean, PhD
Research Scientist
Locations
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Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Countries
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References
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McLean HQ, Levine MZ, King JP, Flannery B, Belongia EA. Serologic response to sequential vaccination with enhanced influenza vaccines: Open label randomized trial among adults aged 65-74 years. Vaccine. 2021 Dec 3;39(49):7146-7152. doi: 10.1016/j.vaccine.2021.10.072. Epub 2021 Nov 10.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MCL10416
Identifier Type: -
Identifier Source: org_study_id