Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults
NCT ID: NCT03314662
Last Updated: 2020-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1778 participants
INTERVENTIONAL
2017-10-17
2018-05-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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aQIV
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine.
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
aTIV-1
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine.
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1)
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
aTIV-2
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
Interventions
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MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1)
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
Eligibility Criteria
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Inclusion Criteria
* Individuals who or whose legal representative(s) have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
* Ability to attend all scheduled visits and to comply with study procedures including diary card completion and follow-up
Exclusion Criteria
* Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
* Abnormal function of the immune system
* Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine prior to the Day 22 blood collection
* Any other clinical condition that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
Additional eligibility criteria may be discussed by contacting the site.
65 Years
ALL
Yes
Sponsors
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Seqirus
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Scientist
Role: STUDY_DIRECTOR
Seqirus
Locations
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Anaheim Clinical Trials
Anaheim, California, United States
Paradigm clinical Research Centers, Inc
Redding, California, United States
Clinical Research of South Florida, an AMR Company
Coral Gables, Florida, United States
Meridan Clinical Research, LLC
Savannah, Georgia, United States
Advanced Clinical Research
Meridian, Idaho, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Heartland Research Associates, LLC - An AMR Company
Newton, Kansas, United States
Heartland Research Associates, LLC - An AMR Company
Wichita, Kansas, United States
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
United Medical Associates
Binghamton, New York, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Medical Research South
Charleston, South Carolina, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Benchmark Research
Fort Worth, Texas, United States
Benchmark Research
San Angelo, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
Advanced Clinical Research
West Jordan, Utah, United States
Countries
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References
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Essink B, Fierro C, Rosen J, Figueroa AL, Zhang B, Verhoeven C, Edelman J, Smolenov I. Immunogenicity and safety of MF59-adjuvanted quadrivalent influenza vaccine versus standard and alternate B strain MF59-adjuvanted trivalent influenza vaccines in older adults. Vaccine. 2020 Jan 10;38(2):242-250. doi: 10.1016/j.vaccine.2019.10.021. Epub 2019 Oct 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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V118_20
Identifier Type: -
Identifier Source: org_study_id
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