Influenza ImmunizationPhase 2NCT04969276
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
A Phase 2 study testing Quadrivalent Inactivated Influenza High Dose and COVID-19 mRNA Vaccine (nucleoside modified) in people with Influenza Immunization and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 6 sites in United States.
Trial summary
The main purpose of this Phase II study was to assess the safety and immunogenicity of a dose of Fluzone High-Dose (HD) Quadrivalent vaccine and a third dose or booster dose of Moderna coronavirus disease 19 (COVID-19) vaccine administered concomitantly or singly in adults 65 years of age and older having received… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Immunization, Healthy Volunteers
- What is being tested?
- Quadrivalent Inactivated Influenza High Dose and COVID-19 mRNA Vaccine (nucleoside modified)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 Jul 2021to 8 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged greater than or equal to >= 65 years of age on the day of inclusion.
- 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.
Who cannot join
- 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, 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Investigational Site Number :8400002
Austin, Texas, 78705
Investigational Site Number :8400005
Centennial, Colorado, 80112
Investigational Site Number :8400003
Glendale, Arizona, 85306
Investigational Site Number :8400001
Peoria, Illinois, 61614
Investigational Site Number :8400006
San Diego, California, 92108
Investigational Site Number :8400004
Vista, California, 92083
About this study
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
The main purpose of this Phase II study was to assess the safety and immunogenicity of a dose of Fluzone High-Dose (HD) Quadrivalent vaccine and a third dose or booster dose of Moderna coronavirus disease 19 (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.
Read the detailed description
Participants were in the study for 6 months (approximately 180 days).
- Conditions
- Influenza Immunization, Healthy Volunteers
- Being tested
- Quadrivalent Inactivated Influenza High Dose, COVID-19 mRNA Vaccine (nucleoside modified)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent Inactivated Influenza High DoseBiological
Also called Fluzone HD Quadrivalent vaccine
Sterile suspension for injection in a pre-filled syringe Intramuscular injection
COVID-19 mRNA Vaccine (nucleoside modified)Biological
Also called Moderna COVID-19 Vaccine (mRNA-1273 vaccine)
Sterile suspension (white to off-white) in multidose vial Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Experimental | 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. Receives: Biological: Quadrivalent Inactivated Influenza High Dose; Biological: COVID-19 mRNA Vaccine (nucleoside modified) |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Active comparator | Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1. Receives: Biological: Quadrivalent Inactivated Influenza High Dose |
| Group 3: COVID-19 Vaccine | Active comparator | Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1. Receives: Biological: COVID-19 mRNA Vaccine (nucleoside modified) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRF. Reported AEs for each arm were presented as pre-specified in the study protocol.
Measured: Within 30 minutes post vaccination
Number of Participants With Solicited Injection Site Reactions
A solicited reaction (SR) was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited injection site reactions included injection site pain, axillary swelling and tenderness, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Reported AEs for each arm were presented as pre-specified in the study protocol.
Measured: Within 7 days post-vaccination
Number of Participants With Solicited Systemic Reactions
A SR was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia, shivering, fatigue, nausea and vomiting. Reported AEs for each arm were presented as pre-specified in the study protocol.
Measured: Within 7 days post-vaccination
Number of Participants With Unsolicited Adverse Events
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.
Measured: Within 21 days post-vaccination
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as one of scientific and medical concern specific to the sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Reported AEs for each arm were presented as pre-specified in the study protocol.
Measured: From Day 1 up to 6 months post-vaccination
Number of Participants With Medically Attended Adverse Events (MAAEs)
A MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department including medical advice seeking during the study visit or routine medical care. Reported AEs for each arm were presented as pre-specified in the study protocol.
Measured: From Day 1 up to 6 months post-vaccination
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1
GMTs of anti-influenza and anti-COVID-19 antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution.
Measured: Day 1 (pre-vaccination)
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22
GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution.
Measured: Day 22 (post-vaccination)
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies
GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01.
Measured: Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution)
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=10 (1/dilution) are reported in the outcome measure.
Measured: Day 1 (pre-vaccination)
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution)
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=10 (1/dilution) are reported in the outcome measure.
Measured: Day 22 (post-vaccination)
Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens
Anti-influenza and anti-COVID-19 antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (<)10 (1/dilution) and a post-vaccination titer >=40 (1/dilution) or a pre-vaccination titer >=10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 22.
Measured: Day 22 (post-vaccination)
Percentage of Participants With Antibody Titers >=40 (1/Dilution)
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=40 (1/dilution) are reported in the outcome measure.
Measured: Day 1 (pre-vaccination)
Percentage of Participants With Antibody Titers >=40 (1/Dilution)
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=40 (1/dilution) are reported in the outcome measure.
Measured: Day 22 (post-vaccination)
Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies
GMCs of Anti-S binding IgG antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) method and were measured in binding antibody units/milliliter (BAU/mL).
Measured: Day 1 (pre-vaccination)
Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies
GMCs of Anti-S binding IgG antibodies were assessed using ELISA method and were measured in BAU/mL.
Measured: Day 22 (post-vaccination)
Geometric Mean Concentration Ratio (GMCR) of Anti-S Binding IgG Antibodies
GMCs of Anti-S binding IgG antibodies were assessed using ELISA method. GMCR was calculated as the ratio of GMC post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01.
Measured: Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies
Percentage of participants with >=2-fold and >=4-fold rise in Anti-S binding IgG antibodies at Day 22 (post-vaccination) are reported in this outcome measure. Percentage of participants with >=2-fold rise are those for whom the computed value at Day 22 was *2 compared to the computed value at Day 1 and percentage of participants with >=4-fold rise are those for whom the computed value at Day 22 was *4 compared to the computed value at Day 1.
Measured: Day 22 (post-vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start16 Jul 2021
- Primary completion8 Feb 2022
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza ImmunizationStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969276
- Sponsor's protocol ID
- QHD00028
- Other IDs
- U1111-1266-7472
- Status last verified
- Sep 2025
- First submitted
- 16 Jul 2021
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 35114141
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04969276
- Acronym / sponsor ID
- QHD00028
- Conditions
- Influenza Immunization, Healthy Volunteers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Posted 13 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this Phase II study was to assess the safety and immunogenicity of a dose of Fluzone High-Dose (HD) Quadrivalent vaccine and a third dose or booster dose of Moderna coronavirus disease 19 (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.
Detailed description
Participants were in the study for 6 months (approximately 180 days).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Experimental | Biological: Quadrivalent Inactivated Influenza High Dose, Biological: COVID-19 mRNA Vaccine (nucleoside modified)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. |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Active comparator | Biological: Quadrivalent Inactivated Influenza High DoseParticipants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1. |
| Group 3: COVID-19 Vaccine | Active comparator | Biological: COVID-19 mRNA Vaccine (nucleoside modified)Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged greater than or equal to >= 65 years of age on the day of inclusion.
- 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.
Key exclusion criteria (18 listed)
- 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, contraindicated IM injection.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicated IM vaccination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrivalent Inactivated Influenza High DoseAlso: Fluzone HD Quadrivalent vaccineSterile suspension for injection in a pre-filled syringe Intramuscular injection | Biological | Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine, Group 2: Fluzone HD Quadrivalent Influenza Vaccine |
| COVID-19 mRNA Vaccine (nucleoside modified)Also: Moderna COVID-19 Vaccine (mRNA-1273 vaccine)Sterile suspension (white to off-white) in multidose vial Intramuscular injection | Biological | Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine, Group 3: COVID-19 Vaccine |
Primary outcome
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Time frame: Within 30 minutes post vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRF. Reported AEs for each arm were presented as pre-specified in the study protocol.
Number of Participants With Solicited Injection Site Reactions
Time frame: Within 7 days post-vaccination
A solicited reaction (SR) was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited injection site reactions included injection site pain, axillary swelling and tenderness, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Reported AEs for each arm were presented as pre-specified in the study protocol.
Number of Participants With Solicited Systemic Reactions
Time frame: Within 7 days post-vaccination
A SR was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia, shivering, fatigue, nausea and vomiting. Reported AEs for each arm were presented as pre-specified in the study protocol.
Number of Participants With Unsolicited Adverse Events
Time frame: Within 21 days post-vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
Time frame: From Day 1 up to 6 months post-vaccination
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as one of scientific and medical concern specific to the sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Reported AEs for each arm were presented as pre-specified in the study protocol.
Number of Participants With Medically Attended Adverse Events (MAAEs)
Time frame: From Day 1 up to 6 months post-vaccination
A MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department including medical advice seeking during the study visit or routine medical care. Reported AEs for each arm were presented as pre-specified in the study protocol.
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1
Time frame: Day 1 (pre-vaccination)
GMTs of anti-influenza and anti-COVID-19 antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution.
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22
Time frame: Day 22 (post-vaccination)
GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution.
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies
Time frame: Day 1 (pre-vaccination) and Day 22 (post-vaccination)
GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01.
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution)
Time frame: Day 1 (pre-vaccination)
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=10 (1/dilution) are reported in the outcome measure.
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution)
Time frame: Day 22 (post-vaccination)
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=10 (1/dilution) are reported in the outcome measure.
Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens
Time frame: Day 22 (post-vaccination)
Anti-influenza and anti-COVID-19 antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (<)10 (1/dilution) and a post-vaccination titer >=40 (1/dilution) or a pre-vaccination titer >=10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 22.
Percentage of Participants With Antibody Titers >=40 (1/Dilution)
Time frame: Day 1 (pre-vaccination)
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=40 (1/dilution) are reported in the outcome measure.
Percentage of Participants With Antibody Titers >=40 (1/Dilution)
Time frame: Day 22 (post-vaccination)
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=40 (1/dilution) are reported in the outcome measure.
Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies
Time frame: Day 1 (pre-vaccination)
GMCs of Anti-S binding IgG antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) method and were measured in binding antibody units/milliliter (BAU/mL).
Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies
Time frame: Day 22 (post-vaccination)
GMCs of Anti-S binding IgG antibodies were assessed using ELISA method and were measured in BAU/mL.
Geometric Mean Concentration Ratio (GMCR) of Anti-S Binding IgG Antibodies
Time frame: Day 1 (pre-vaccination) and Day 22 (post-vaccination)
GMCs of Anti-S binding IgG antibodies were assessed using ELISA method. GMCR was calculated as the ratio of GMC post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01.
Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies
Time frame: Day 22 (post-vaccination)
Percentage of participants with >=2-fold and >=4-fold rise in Anti-S binding IgG antibodies at Day 22 (post-vaccination) are reported in this outcome measure. Percentage of participants with >=2-fold rise are those for whom the computed value at Day 22 was *2 compared to the computed value at Day 1 and percentage of participants with >=4-fold rise are those for whom the computed value at Day 22 was *4 compared to the computed value at Day 1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35114141Izikson 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.
- QHD00028 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quadrivalent Inactivated Influenza High Dose and COVID-19 mRNA Vaccine (nucleoside modified) in people with Influenza Immunization and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Immediate Unsolicited Adverse Events (AEs) (time frame: Within 30 minutes post vaccination). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04969276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.