Trial Outcomes & Findings for 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 (NCT NCT05050318)
NCT ID: NCT05050318
Last Updated: 2025-09-12
Results Overview
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.
COMPLETED
PHASE4
90 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)
2025-09-12
Participant Flow
Participants were enrolled from 08 September 2021 to 20 September 2021 at 2 active sites in the United States.
A total of 90 participants were enrolled in the study.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
30
|
|
Overall Study
Vaccinated
|
28
|
31
|
30
|
|
Overall Study
COMPLETED
|
28
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Protocol Deviation
|
1
|
0
|
0
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months
n=28 Participants
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.
|
Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years
n=31 Participants
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.
|
Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years
n=30 Participants
Participants aged \>= 65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Age, Continuous
|
1.83 years
STANDARD_DEVIATION 0.410 • n=99 Participants
|
4.81 years
STANDARD_DEVIATION 1.83 • n=107 Participants
|
73.3 years
STANDARD_DEVIATION 4.31 • n=206 Participants
|
27.0 years
STANDARD_DEVIATION 33.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
84 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months
n=28 Participants
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.
|
Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years
n=31 Participants
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.
|
|---|---|---|
|
Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2
Visit 1
|
28 Participants
|
31 Participants
|
|
Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2
Visit 2
|
20 Participants
|
31 Participants
|
|
Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2
Visit 3
|
7 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2)Population: Analysis was performed on all vaccinated participants.
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.
Outcome measures
| Measure |
Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months
n=30 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3
Visit 1
|
30 Participants
|
—
|
|
Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3
Visit 2
|
30 Participants
|
—
|
Adverse Events
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
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER