Influenza ImmunizationPhase 4NCT05050318

Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively

A Phase 4 study testing Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation and Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation in people with Influenza Immunization and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (>=) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for submission to CBER to… Read more about this study

Who is it for?: Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for: Influenza Immunization, Healthy Volunteers
What is being tested?: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation and Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 2 sitesUnited States
Study dates: 8 Sep 2021to 10 Nov 2021
Phase: Phase 4
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 6 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Aged 6 months to < 9 years or >= 65 years of age on the day of first study vaccination (study product administration).
For infants and toddlers, born at full term of pregnancy (>=37 weeks) or born after a gestation period of 27 through 36 weeks.
For participants 6 to < 12 months of age, born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 5.5 pound (lbs) (2.5 kilogram [kg]).
Informed consent form (ICF) has been signed and dated by participants >= 65 years of age.
Assent form has been signed and dated by participants 7 to < 9 years of age, and ICF has been signed and dated by parent(s) or another legally acceptable representative for participants 6 months to < 9 years of age.
Participants or participant and parent/legally acceptable representative (of participants 6 months to < 9 years of age) were able to attend all scheduled visits and complied with all study procedures.

Who cannot join

Participants are excluded from the study if any of the following criteria apply:
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.
Thrombocytopenia, contraindicating IM injection, at the discretion of the Investigator.
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating 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 19Show 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 [38.0° Celsius]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
History of serious adverse reaction to any influenza vaccine.
Personal history of Guillain-Barré syndrome.
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.
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.
Receipt of any vaccine in the 30 days preceding the first study intervention administration, or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
Previous vaccination against influenza (in the 2021-2022 influenza season) with an investigational or marketed vaccine.
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 a vaccine, drug, medical device, or medical procedure.
Note: Participants might be considered eligible for enrollment if no intervention for the other study occurred within the 30 days prior to the first study vaccination and none were planned before the participant would complete safety surveillance for the present 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

2 sites in 1 country.

United States2 sites

Investigational Site Number :8400001
Bardstown, Kentucky, 40004
Investigational Site Number :8400002
Salt Lake City, Utah, 84121

Other trials in United States

About this study

Official title: Collection of Serum Samples From Children 6 Months to < 9 Years of Age Who Received Fluzone® Quadrivalent and Adults ≥ 65 Years of Age Who Received Fluzone® High-Dose Quadrivalent, Influenza Vaccines, 2021-2022 Formulations

Read the detailed description

Study duration per participant was approximately 28 days for participants with 6 months to < 9 years of age, and 21 days for participants >= 65 years of age, including 1 to 3 visits (1 or 2 vaccination visits) and 1 or 2 telephone calls, depending on study Group.

Conditions: Influenza Immunization, Healthy Volunteers
Being tested: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation, Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulationBiological
Also called Fluzone® Quadrivalent
Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)
Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulationBiological
Also called Fluzone High-Dose Quadrivalent
Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)

Study groups in NCT05050318
Study group	Role	What they receive
Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months	Experimental	Participants aged 6 to <36 months received a 0.5-milliliters (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP), a second dose was administered at Day 28. Receives: Biological: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation
Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years	Experimental	Participants aged 3 to <9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28. Receives: Biological: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation
Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years	Experimental	Participants aged >= 65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1. Receives: Biological: Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2
Blood samples were collected from participants at first vaccination at Visit 1 (Day 1; pre-vaccination) and at Day 28 after final vaccination either at Visit 2 (Visit 1 + 28 days) for participants who received 1 dose of influenza vaccine; or at Visit 3 (Visit 2 + 28 days) for participants who received 2 doses of influenza vaccine as recommended by ACIP. Collected blood samples were provided to Center for Biologics Evaluation and Research (CBER) for further analysis by World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Measured: Visit 1 (Day 1; pre-vaccination) and 28 days post-final vaccination at Visit 2 (for participants with 1 vaccination)/Visit 3 (for participants with 2 vaccination)
Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3
Blood samples were collected from participants at first vaccination at Visit 1 (Day 1; pre-vaccination) and 21 days after vaccination (Visit 2). Collected blood samples were provided to CBER for further analysis by WHO, CDC, and FDA to support formulation recommendations for subsequent influenza vaccines.
Measured: Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 202110 Nov 2021

First posted20 Sep 2021
Study start8 Sep 2021
Primary completion10 Nov 2021
Study completion10 Nov 2021

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.
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 4
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05050318
Sponsor's protocol ID: GRC00102
Other IDs: U1111-1266-5255
Status last verified: Sep 2025
First submitted: 3 Sep 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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: Collection of Serum Samples From Children 6 Months to < 9 Years of Age Who Received Fluzone® Quadrivalent and Adults ≥ 65 Years of Age Who Received Fluzone® High-Dose Quadrivalent, Influenza Vaccines, 2021-2022 Formulations
ClinicalTrials.gov ID: NCT05050318
Acronym / sponsor ID: GRC00102
Conditions: Influenza Immunization, Healthy Volunteers
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 8 Sep 2021 (actual)
Primary completion: 10 Nov 2021 (actual)
Study completion: 10 Nov 2021 (actual)
First posted: 20 Sep 2021 (actual)
Results: Posted 14 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months	Experimental	Biological: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulationParticipants aged 6 to <36 months received a 0.5-milliliters (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP), a second dose was administered at Day 28.
Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years	Experimental	Biological: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulationParticipants aged 3 to <9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years	Experimental	Biological: Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulationParticipants aged >= 65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Aged 6 months to < 9 years or >= 65 years of age on the day of first study vaccination (study product administration).
For infants and toddlers, born at full term of pregnancy (>=37 weeks) or born after a gestation period of 27 through 36 weeks.
For participants 6 to < 12 months of age, born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 5.5 pound (lbs) (2.5 kilogram [kg]).
Informed consent form (ICF) has been signed and dated by participants >= 65 years of age.
Assent form has been signed and dated by participants 7 to < 9 years of age, and ICF has been signed and dated by parent(s) or another legally acceptable representative for participants 6 months to < 9 years of age.

Key exclusion criteria (19 listed)

Participants are excluded from the study if any of the following criteria apply:
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.
Thrombocytopenia, contraindicating IM injection, at the discretion of the Investigator.
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating 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
Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulationAlso: Fluzone® QuadrivalentSuspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)	Biological	Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months, Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years
Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulationAlso: Fluzone High-Dose QuadrivalentSuspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)	Biological	Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years

Primary outcome

Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2
Time frame: Visit 1 (Day 1; pre-vaccination) and 28 days post-final vaccination at Visit 2 (for participants with 1 vaccination)/Visit 3 (for participants with 2 vaccination)
Blood samples were collected from participants at first vaccination at Visit 1 (Day 1; pre-vaccination) and at Day 28 after final vaccination either at Visit 2 (Visit 1 + 28 days) for participants who received 1 dose of influenza vaccine; or at Visit 3 (Visit 2 + 28 days) for participants who received 2 doses of influenza vaccine as recommended by ACIP. Collected blood samples were provided to Center for Biologics Evaluation and Research (CBER) for further analysis by World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3
Time frame: Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2)
Blood samples were collected from participants at first vaccination at Visit 1 (Day 1; pre-vaccination) and 21 days after vaccination (Visit 2). Collected blood samples were provided to CBER for further analysis by WHO, CDC, and FDA to support formulation recommendations for subsequent influenza vaccines.

Results and safety

Results posted to the registry on 14 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months	29	28
Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years	31	31
Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years	30	30

Primary outcome: Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2

Time frame: Visit 1 (Day 1; pre-vaccination) and 28 days post-final vaccination at Visit 2 (for participants with 1 vaccination)/Visit 3 (for participants with 2 vaccination). Count of participants. Unit: Participants

Measure	Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months n = 28	Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years n = 31
Visit 1	28	31
Visit 2	20	31
Visit 3	7	0

Population analysed: Analysis was performed on all vaccinated participants. Here, 'number analyzed' = participants with available data for each specified category.

Primary outcome: Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3

Time frame: Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2). Count of participants. Unit: Participants

Measure	Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years n = 30
Visit 1	30
Visit 2	30

Population analysed: Analysis was performed on all vaccinated participants.

Adverse events

Time frame: Reported adverse events (AE) data were collected from Visit 1 (Day 1) up to end of the study (i.e., up to Day 21 for adult participants [>=65 years], up to Day 28 for child participants [6 to <9 years] who received 1 dose and up to Day 56 for participants who received 2 doses).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months	0 of 28 (0%)	0 of 28 (0%)	0 of 28
Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years	0 of 30 (0%)	0 of 30 (0%)	0 of 30

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.
GRC00102 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 Pasteur, a Sanofi Company

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 19 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 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 14 Sep 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 Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 (time frame: Visit 1 (Day 1; pre-vaccination) and 28 days post-final vaccination at Visit 2 (for participants with 1 vaccination)/Visit 3 (for participants with 2 vaccination)). The study lists 2 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 NCT05050318.

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.