Healthy Volunteers, Influenza Immunization
Conditions
Brief 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 aid in the influenza vaccine strain selection process.
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.
Interventions
BIOLOGICALFluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation
Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)
BIOLOGICALFluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation
Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 08 September 2021 to 20 September 2021 at 2 active sites in the United States.
Pre-assignment details
A total of 90 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 31 |
| 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. | 30 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Deviation | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months | Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years | Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 28 Participants | 31 Participants | 0 Participants | 59 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 30 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1.83 years STANDARD_DEVIATION 0.41 | 4.81 years STANDARD_DEVIATION 1.83 | 73.3 years STANDARD_DEVIATION 4.31 | 27.0 years STANDARD_DEVIATION 33.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 28 Participants | 30 Participants | 84 Participants |
| Sex: Female, Male Female | 11 Participants | 14 Participants | 15 Participants | 40 Participants |
| Sex: Female, Male Male | 17 Participants | 17 Participants | 15 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 0 / 28 | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 28 | 0 / 31 | 0 / 30 |
Outcome results
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.
Time frame: Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2)
Population: Analysis was performed on all vaccinated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months | Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3 | Visit 1 | 30 Participants |
| Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months | Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3 | Visit 2 | 30 Participants |
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.
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)
Population: Analysis was performed on all vaccinated participants. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months | Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 | Visit 1 | 28 Participants |
| Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months | Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 | Visit 2 | 20 Participants |
| Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months | Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 | Visit 3 | 7 Participants |
| Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years | Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 | Visit 1 | 31 Participants |
| Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years | Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 | Visit 2 | 31 Participants |
| Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years | Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 | Visit 3 | 0 Participants |