InfluenzaPhase 4GRC00097NCT04109222
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
A Phase 4 study testing Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation and Fluzone High-Dose vaccine, 2019-2020 formulation in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 2 sites in United States.
Trial summary
The primary objective of the study was to provide sera (collected from participants before vaccination [Blood Sample 1] and after final vaccination [Blood Sample 2]) to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control… Read more about this study
- Who is it for?
- Ages 6 months to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation and Fluzone High-Dose vaccine, 2019-2020 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
- 30 Sep 2019to 10 Dec 2019
- 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 to 83 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- An individual who fulfilled all of the following criteria were eligible for study enrollment:
- Aged 6 months to < 9 years or >= 65 years of age on the day of first study vaccination (study product administration).
- For participants 6 to < 12 months of age, born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 5.5 pounds (2.5 kilograms).
- Informed consent form (ICF) had been signed and dated by participants >= 65 years of age.
- Assent form had been signed and dated by participants 7 to < 9 years of age, and ICF had been signed and dated by parent(s) or guardian(s) for participants 6 months to < 9 years of age.
- Participant and parent/guardian (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
- An individual who fulfilled any of the following criteria were excluded from study enrollment:
- 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.
- Receipt of any vaccine in the 30 days preceding the first study vaccination, 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 2019-2020 influenza season) with either study vaccine or another vaccine.
- Receipt of immune globulins, blood, or blood-derived products in the 3 months preceding planned inclusion.
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the 6 months preceding planned inclusion; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the 3 months preceding planned inclusion).
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- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to study vaccine or to a vaccine containing any of the same substances.
- Thrombocytopenia, which might be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Current alcohol abuse or drug addiction.
- 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 planned vaccination or febrile illness (temperature >= 100.4 degree (°) Fahrenheit [38.0 °Celsius]). A prospective participant were not included in the study until the condition had resolved or the febrile event had subsided.
- 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) or in-laws of the Investigator or employee with direct involvement in the proposed study.
- 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 participants 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.
- 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 8400002
Bardstown, Kentucky, 40004
Investigational Site Number 8400001
Salt Lake City, Utah, 84121
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, Influenza Vaccines, 2019-2020 Formulations
The primary objective of the study was to provide sera (collected from participants before vaccination [Blood Sample 1] and after final vaccination [Blood Sample 2]) to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Read the detailed description
All participants received 1 intramuscular injection of the study vaccine associated with their assigned group at Visit 1. For participants 6 months to < 9 years of age for whom 2 doses of influenza vaccine are recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second intramuscular injection of Fluzone Quadrivalent vaccine was administered at Visit 2 (28 days after Visit 1).
Blood specimens were obtained from all participants prior to the first vaccination:
- At Visit 1 (Day 0) and 28 days following the final vaccination (Visit 2, if no study vaccine was administered at Visit 2; or Visit 3, if a second dose of study vaccine was administered at Visit 2), for participants 6 months to < 9 years of age (Group 1 and Group 2)
- At Visit 1 and 21 (window, 21-28) days post-vaccination (Visit 2), for participants greater than or equal to (>=) 65 years of age (Group 3) Serious Adverse Events (SAEs), suspected unexpected serious adverse reactions (SUSARs), or Adverse Event of Special Interests (AESIs) were collected from Visit 1 through Visit 2 for participants receiving 1 dose of study vaccine, and from Visit 1 through Visit 3 for participants receiving 2 doses of study vaccine.
Study duration per participant was approximately 28 days for participants 6 months to less than (<) 9 years of age, and 21 days for participants >= 65 years of age.
- Conditions
- Influenza
- Being tested
- Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation, Fluzone High-Dose vaccine, 2019-2020 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), 2019-2020 formulationBiological
Also called Fluzone® Quadrivalent, No Preservative
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Fluzone High-Dose vaccine, 2019-2020 formulationBiological
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
| 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 0. 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), 2019-2020 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 0. 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), 2019-2020 formulation |
| Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 years | Experimental | Participants aged >=65 years received a of 0.5-mL dose of Fluzone high-dose vaccine, intramuscularly, at Day 0. Receives: Biological: Fluzone High-Dose vaccine, 2019-2020 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 before first vaccination at Visit 1 (Day 0; 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 0; pre-vaccination) and 28 days post-final vaccination at Visit 2/Visit 3
Number of Participants Aged >= 65 Years Who Provided Serum Samples for Analysis: Group 3
Blood samples were collected from participants before vaccination at Visit 1 (Day 0; 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 0; 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.
- First posted30 Sep 2019
- Study start30 Sep 2019
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
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 InfluenzaStudies 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)
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 Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109222
- Sponsor's protocol ID
- GRC00097
- Other IDs
- U1111-1225-1118
- Acronym
- GRC00097
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2019
- 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
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, Influenza Vaccines, 2019-2020 Formulations
- ClinicalTrials.gov ID
- NCT04109222
- Acronym / sponsor ID
- GRC00097 / GRC00097
- Conditions
- Influenza
- 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
- 30 Sep 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Posted 17 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study was to provide sera (collected from participants before vaccination [Blood Sample 1] and after final vaccination [Blood Sample 2]) to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Detailed description
All participants received 1 intramuscular injection of the study vaccine associated with their assigned group at Visit 1. For participants 6 months to < 9 years of age for whom 2 doses of influenza vaccine are recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second intramuscular injection of Fluzone Quadrivalent vaccine was administered at Visit 2 (28 days after Visit 1).
Blood specimens were obtained from all participants prior to the first vaccination:
- At Visit 1 (Day 0) and 28 days following the final vaccination (Visit 2, if no study vaccine was administered at Visit 2; or Visit 3, if a second dose of study vaccine was administered at Visit 2), for participants 6 months to < 9 years of age (Group 1 and Group 2)
- At Visit 1 and 21 (window, 21-28) days post-vaccination (Visit 2), for participants greater than or equal to (>=) 65 years of age (Group 3) Serious Adverse Events (SAEs), suspected unexpected serious adverse reactions (SUSARs), or Adverse Event of Special Interests (AESIs) were collected from Visit 1 through Visit 2 for participants receiving 1 dose of study vaccine, and from Visit 1 through Visit 3 for participants receiving 2 doses of study vaccine.
Study duration per participant was approximately 28 days for participants 6 months to less than (<) 9 years of age, and 21 days for participants >= 65 years of age.
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), 2019-2020 formulationParticipants aged 6 to <36 months received a 0.5-milliliters (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per 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), 2019-2020 formulationParticipants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. 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 Influenza Vaccine: >= 65 years | Experimental | Biological: Fluzone High-Dose vaccine, 2019-2020 formulationParticipants aged >=65 years received a of 0.5-mL dose of Fluzone high-dose vaccine, intramuscularly, at Day 0. |
Who may qualify
- Ages
- 6 months to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- An individual who fulfilled all of the following criteria were eligible for study enrollment:
- Aged 6 months to < 9 years or >= 65 years of age on the day of first study vaccination (study product administration).
- For participants 6 to < 12 months of age, born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 5.5 pounds (2.5 kilograms).
- Informed consent form (ICF) had been signed and dated by participants >= 65 years of age.
- Assent form had been signed and dated by participants 7 to < 9 years of age, and ICF had been signed and dated by parent(s) or guardian(s) for participants 6 months to < 9 years of age.
Key exclusion criteria (20 listed)
- An individual who fulfilled any of the following criteria were excluded from study enrollment:
- 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.
- Receipt of any vaccine in the 30 days preceding the first study vaccination, 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 2019-2020 influenza season) with either study vaccine or another vaccine.
- Receipt of immune globulins, blood, or blood-derived products in the 3 months preceding planned inclusion.
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), 2019-2020 formulationAlso: Fluzone® Quadrivalent, No PreservativePharmaceutical form: Suspension for injection Route of administration: Intramuscular | Biological | Group 1: Fluzone Quadrivalent Influenza vaccine: 6 to < 36 Months, Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 years |
| Fluzone High-Dose vaccine, 2019-2020 formulationPharmaceutical form: Suspension for injection Route of administration: Intramuscular | Biological | Group 3: Fluzone High-Dose 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 0; pre-vaccination) and 28 days post-final vaccination at Visit 2/Visit 3
Blood samples were collected from participants before first vaccination at Visit 1 (Day 0; 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 0; pre-vaccination) and 21 days post-vaccination (Visit 2)
Blood samples were collected from participants before vaccination at Visit 1 (Day 0; 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
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.
- GRC00097 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?
A Phase 4 study testing Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation and Fluzone High-Dose vaccine, 2019-2020 formulation in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 2 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 6 inclusion and 20 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 17 Dec 2020). 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 0; pre-vaccination) and 28 days post-final vaccination at Visit 2/Visit 3). 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?
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.