Study of a Quadrivalent High-Dose Influenza Vaccine and a Moderna COVID-19 Vaccine Administered Either Concomitantly or Singly in Participants 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine
NCT ID: NCT04969276
Last Updated: 2025-09-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
306 participants
INTERVENTIONAL
2021-07-16
2022-02-08
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
NONE
Study Groups
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Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine
Participants received an injection of 0.7 milliliters (mL), fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, intramuscularly (IM) on Day 1.
Quadrivalent Inactivated Influenza High Dose
Sterile suspension for injection in a pre-filled syringe Intramuscular injection
COVID-19 mRNA Vaccine (nucleoside modified)
Sterile suspension (white to off-white) in multidose vial Intramuscular injection
Group 2: Fluzone HD Quadrivalent Influenza Vaccine
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Quadrivalent Inactivated Influenza High Dose
Sterile suspension for injection in a pre-filled syringe Intramuscular injection
Group 3: COVID-19 Vaccine
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
COVID-19 mRNA Vaccine (nucleoside modified)
Sterile suspension (white to off-white) in multidose vial Intramuscular injection
Interventions
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Quadrivalent Inactivated Influenza High Dose
Sterile suspension for injection in a pre-filled syringe Intramuscular injection
COVID-19 mRNA Vaccine (nucleoside modified)
Sterile suspension (white to off-white) in multidose vial Intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In good health or with underlying medical condition(s) that were judged to be stable by the Investigator. A stable medical condition was defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
* Participants who previously received 2 injections of Moderna COVID-19 Vaccine with the second dose received at least 5 months before Visit 1.
* Abled to attend all scheduled visits and to complied with all study procedures.
Exclusion Criteria
* Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances.
* Previous dermal filler injection (either lips or face fillers).
* Thrombocytopenia, contraindicated IM injection.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicated IM vaccination.
* Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion.
* Moderate or severe acute illness/infection (according to Investigator judgment) on the day of study intervention administration or febrile illness (temperature \>= 100.4°Fahrenheit \[F\] \[38.0° Celsius {C}\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
* History of serious adverse reaction to any influenza or COVID-19 vaccines.
* Personal history of Guillain-Barré syndrome (GBS).
* Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
* Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.
* Any condition that in the opinion of the Investigator posed a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
* Receipt of any vaccine in the 4 weeks preceding the study intervention(s) administration or planned receipt of any vaccine in the period between Visit 01 and 4 weeks following the study intervention(s) administration. Note: Vaccination of Group 3 participants with Fluzone High-Dose Quadrivalent vaccine at the end of the study was not considered by the Sponsor as meeting this exclusion criterion.
* Receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months.
* Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating vaccine, drug, medical device, or medical procedure.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
* The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
65 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number :8400003
Glendale, Arizona, United States
Investigational Site Number :8400006
San Diego, California, United States
Investigational Site Number :8400004
Vista, California, United States
Investigational Site Number :8400005
Centennial, Colorado, United States
Investigational Site Number :8400001
Peoria, Illinois, United States
Investigational Site Number :8400002
Austin, Texas, United States
Countries
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References
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Izikson R, Brune D, Bolduc JS, Bourron P, Fournier M, Moore TM, Pandey A, Perez L, Sater N, Shrestha A, Wague S, Samson SI. Safety and immunogenicity of a high-dose quadrivalent influenza vaccine administered concomitantly with a third dose of the mRNA-1273 SARS-CoV-2 vaccine in adults aged >/=65 years: a phase 2, randomised, open-label study. Lancet Respir Med. 2022 Apr;10(4):392-402. doi: 10.1016/S2213-2600(21)00557-9. Epub 2022 Feb 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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QHD00028 Plain Language Results Summary
Other Identifiers
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U1111-1266-7472
Identifier Type: REGISTRY
Identifier Source: secondary_id
QHD00028
Identifier Type: -
Identifier Source: org_study_id
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