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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-5255 | Registry Identifier | ICTRP |
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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 aid in the influenza vaccine strain selection process.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation | Biological | Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2) |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :8400001 | Bardstown | Kentucky | 40004 | United States | ||
| Investigational Site Number :8400002 |
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| Label | URL |
|---|---|
| GRC00102 Plain Language Results Summary | View source |
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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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A total of 90 participants were enrolled in the study.
Participants were enrolled from 08 September 2021 to 20 September 2021 at 2 active sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months | Participants aged 6 to less than (<) 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2021 |
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|
| Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation | Biological | Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM) |
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| Salt Lake City |
| Utah |
| 84121 |
| United States |
| FG001 | Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years | 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. |
| FG002 | Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years | Participants aged greater than or equal to (>=) 65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1. |
| Vaccinated |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on all vaccinated participants which included all participants who had received at least 1 dose of the study vaccine.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months | Participants aged 6 to <36 months 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. |
| BG001 | Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years | 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. |
| BG002 | Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years | Participants aged >= 65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | 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. | Analysis was performed on all vaccinated participants. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Count of Participants | Participants | 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) |
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| Primary | 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. | Analysis was performed on all vaccinated participants. | Posted | Count of Participants | Participants | Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2) |
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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).
Analysis was performed on all vaccinated participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months | Participants aged 6 to <36 months 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 | 0 | 28 | 0 | 28 | 0 | 28 |
| EG001 | Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years | Participants aged >=65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1. | 0 | 30 | 0 | 30 | 0 | 30 |
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The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Aug 18, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D017778 | Vaccines, Combined |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Visit 2 |
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| Visit 3 |
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