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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

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ClinicalTrials.gov Identifier: NCT04969276
Recruitment Status : Completed
First Posted : July 20, 2021
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:
The main purpose of this Phase II study is to assess the safety and immunogenicity of a dose of Fluzone High-Dose Quadrivalent vaccine and a third dose or booster dose of Moderna COVID-19 Vaccine administered concomitantly or singly in adults 65 years of age and older having received their second dose of the 2-dose schedule of Moderna COVID-19 Vaccine at least 5 months before enrollment in the study

Condition or disease Intervention/treatment Phase
Influenza (Healthy Volunteers) Biological: Quadrivalent Inactivated Influenza High Dose Biological: COVID-19 mRNA Vaccine (nucleoside modified) Phase 2

Detailed Description:
Participants will be in the study for 6 months (approximately 180 days).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II, Open-label Study to Assess the Safety and Immunogenicity of Fluzone® High-Dose Quadrivalent (Influenza Vaccine), 2021-2022 Formulation and a Third Dose of Moderna COVID-19 Vaccine (mRNA-1273 Vaccine) Administered Either Concomitantly or Singly in Adults 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine
Actual Study Start Date : July 16, 2021
Actual Primary Completion Date : February 8, 2022
Actual Study Completion Date : February 8, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: Fluzone HD and Covid-19 vaccine
Concomitant administration of Fluzone High-Dose Quadrivalent vaccine and COVID-19 mRNA Vaccine
Biological: Quadrivalent Inactivated Influenza High Dose
Sterile suspension for injection in a pre-filled syringe Intramuscular injection
Other Name: Fluzone HD Quadrivalent vaccine

Biological: COVID-19 mRNA Vaccine (nucleoside modified)
Sterile suspension (white to off-white) in multidose vial Intramuscular injection
Other Name: Moderna COVID-19 Vaccine (mRNA-1273 vaccine)

Active Comparator: Group 2: Fluzone HD vaccine
Administration of Fluzone High-Dose Quadrivalent vaccine alone
Biological: Quadrivalent Inactivated Influenza High Dose
Sterile suspension for injection in a pre-filled syringe Intramuscular injection
Other Name: Fluzone HD Quadrivalent vaccine

Active Comparator: Group 3: Covid-19 vaccine
Administration of COVID-19 mRNA Vaccine alone
Biological: COVID-19 mRNA Vaccine (nucleoside modified)
Sterile suspension (white to off-white) in multidose vial Intramuscular injection
Other Name: Moderna COVID-19 Vaccine (mRNA-1273 vaccine)




Primary Outcome Measures :
  1. Number of participants with immediate adverse events (AEs) [ Time Frame: From the injection up to 30 minutes after vaccination ]
    Unsolicited systemic AEs that occur within 30 minutes after vaccination

  2. Number of participants with solicited injection site reactions or systemic reactions [ Time Frame: From the day of vaccination (D01) until 7 days after vaccination (D08). ]
    Number of participants with solicited injection site reactions and systemic reactions

  3. Number of participants with unsolicited AEs [ Time Frame: From the day of vaccination (D01) until 21 days after vaccination (D22). ]
    AEs that do not fulfill the conditions of solicited reactions

  4. Number of participants with serious adverse events (SAEs) and Adverse Events of Special Interest (AESIs) [ Time Frame: From the day of vaccination (D01) until 6 months after vaccination. ]
    SAEs reported throughout the study, including adverse events of special interest (AESI)s

  5. Number of participants with medically attended adverse events (MAAE)s [ Time Frame: From the day of vaccination (D01) until 6 months after vaccination. ]
    AEs with a new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department

  6. Hemagglutination inhibition (HAI) individual titer [ Time Frame: Day of vaccination (D01) and 21 days after vaccination (D22). ]
    Antibody titers measured by HAI in each group before and after vaccination with Fluzone High-Dose Quadrivalent vaccine

  7. Individual HAI titers ratio D22/D01 [ Time Frame: Day of vaccination (D01) and 21 days after vaccination (D22). ]
    Ratios of antibody titers measured by HAI in each group before and after vaccination with Fluzone High-Dose Quadrivalent vaccine

  8. Number of participants with influenza vaccine antibody titer ≥ 10 [ Time Frame: Day of vaccination (D01) and 21 days after vaccination (D22). ]
    Detectable HAI titer, ie, with a titer ≥ 10 (1/dil) at D01 and 21 days after injection of Fluzone High-Dose Quadrivalent vaccine

  9. Number of participants with influenza vaccine antibody titer ≥ 40 [ Time Frame: Day of vaccination (D01) and 21 days after vaccination (D22). ]
    HAI titer ≥ 40 (1/dil) on D01 and 21 days after injection of Fluzone High-Dose Quadrivalent vaccine

  10. Number of participants with seroconversion [ Time Frame: Day of vaccination (D01) and 21 days after vaccination (D22). ]
    Number of participants with titer < 10 [1/dil] at D01 and post-vaccination titer ≥ 40 [1/dil] at D22, or titer ≥ 10 [1/dil] at D01 and a ≥ 4-fold-rise in titer [1/dil] at D22 after Fluzone High-Dose Quadrivalent vaccine

  11. Individual anti-S binding IgG concentration [ Time Frame: Day of vaccination (D01) and 21 days after vaccination (D22). ]
    Individual anti-S binding IgG concentration on D01 and 21 days after injection of Moderna COVID-19 Vaccine

  12. Individual anti-S binding IgG concentration ratio D22/D01 [ Time Frame: Day of vaccination (D01) and 21 days after vaccination (D22). ]
    Ratios of antibody titers measured by anti-S binding IgG in each group before and after vaccination with Moderna COVID-19 vaccine

  13. 2-fold-rise in anti-S binding IgG concentration [ Time Frame: Day of vaccination (D01) and 21 days after vaccination (D22). ]
    Rise in antibody titers against SARS-Cov-2 21 days after vaccination with Moderna COVID-19 vaccine

  14. 4-fold-rise in anti-S binding IgG concentration [ Time Frame: Day of vaccination (D01) and 21 days after vaccination (D22). ]
    Rise in antibody titers against SARS-Cov-2 21 days after vaccination with Moderna COVID-19 vaccine



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥ 65 years of age on the day of inclusion
  • In good health or with underlying medical condition(s) that are judged to be stable by the Investigator. A stable medical condition is 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
  • Able to attend all scheduled visits and to comply with all study procedures

Exclusion Criteria:

  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the 3 months preceding planned inclusion)
  • 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, contraindicating IM injection
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
  • Chronic illness that, in the opinion of the Investigator, is 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°F [38.0°C]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has 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 would pose 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 V01 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 will not be 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 (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04969276


Locations
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United States, Arizona
Investigational Site Number :8400003
Glendale, Arizona, United States, 85306
United States, California
Investigational Site Number :8400006
San Diego, California, United States, 92108
Investigational Site Number :8400004
Vista, California, United States, 92083
United States, Colorado
Investigational Site Number :8400005
Centennial, Colorado, United States, 80112
United States, Illinois
Investigational Site Number :8400001
Peoria, Illinois, United States, 61614
United States, Texas
Investigational Site Number :8400002
Austin, Texas, United States, 78705
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT04969276    
Other Study ID Numbers: QHD00028
U1111-1266-7472 ( Registry Identifier: ICTRP )
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases
Orthomyxoviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs