Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations
Study Details
Study Description
Brief Summary
The aim of the study was to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and in adults 18 to < 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥65 years of age.
Primary Observational Objectives
- To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the safety of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
Observational Objectives:
-
To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
-
To submit available sera from approximately 90 participants (30 participants 3 to < 9 years of age and 30 participants 18 to < 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 participants ≥ 65 years of age who receive Fluzone High-Dose vaccine) to 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
All participants received a 0.5-mL intramuscular dose of their assigned vaccine at Visit 1. For participants 3 to < 9 years of age for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine (of the same volume) was administered during Visit 2.
Solicited adverse reaction (AR) information was collected for 7 days after vaccination. Unsolicited non-serious adverse event (AE) and serious adverse event (SAE) information was collected from Visit 1 to Visit 2 or from Visit 1 to Visit 3 for those participants receiving 2 doses of study vaccine.
Immunogenicity was evaluated in all participants prior to vaccination on Day 0 (Visit 1) and after the final vaccination on Day 28 for 3 to < 9 year olds and Day 21 days for adults 18 years and older.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. |
Biological: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative
0.5 mL, Intramuscular
Other Names:
|
| Experimental: Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. |
Biological: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative
0.5 mL, Intramuscular
Other Names:
|
| Experimental: Fluzone High-Dose Vaccine Group 3: ≥ 65 Years Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. |
Biological: Fluzone High-Dose, vaccine, 2016-2017 formulation
0.5 mL, Intramuscular
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) [Within 7 days after any vaccination]
Solicited injection site reactions: Pain (Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities), erythema & swelling (Grade 1: >0 to <25 mm;Grade 2: ≥ 25 to < 50 mm; Grade 3: ≥ 50 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise & myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site & systemic reactions are reported; number of participants with Grade 3 solicited injection-site & systemic reactions are also reported.
- Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) [Within 7 days after any vaccination]
Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant; prevents daily activity), erythema & swelling (Grade 1: ≥ 25 to ≤ 50 mm; Grade 2: ≥ 51 to ≤ 100 mm; Grade 3: >100 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise & myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site & systemic reactions are reported; number of participants with Grade 3 solicited injection-site & systemic reactions are also reported.
Secondary Outcome Measures
- Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years) [Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)]
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.
- Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years) [Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)]
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.
- Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years) [Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)]
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 strains: H1N1, H3N2, Victoria lineage.
- Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years) [Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)]
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.
- Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years) [Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)]
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.
- Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years) [Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)]
Anti-influenza antibodies were measured using HAI assay for 3 strains: H1N1, H3N2, Victoria lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged 3 to <9 years or adult aged ≥ 18 years on the day of first study vaccination (study product administration) .
-
Informed consent form had been signed and dated by participants ≥ 18 years of age.
-
Assent form had been signed and dated by participants 7 to <9 years of age, and informed consent form (ICF) has been signed and dated by parent(s) or guardian(s) for participants 3 to <9 years of age.
-
Participant and parent/guardian (of participants 3 to <9 years of age) were able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
-
Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
-
Participation at the time of study enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
-
Receipt of any vaccine in the 30 days preceding the first trial 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 2016-2017 influenza season) with either the trial vaccine or another vaccine.
-
Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
-
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 past 3 months).
-
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
-
Thrombocytopenia, which may 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, is at a stage where it might interfere with trial 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°F [38.0°C]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
-
Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study (participants ≥18 years of age) or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study (all participants).
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bardstown | Kentucky | United States | 40004 | |
| 2 | Metairie | Louisiana | United States | 70002 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- GRC71
- U1111-1174-4738
Study Results
Participant Flow
| Recruitment Details | Study participants were enrolled in 2 centers in the United States from 15 September 2016 to 28 September 2016. |
|---|---|
| Pre-assignment Detail | A total of 180 participants (60 for each group) were enrolled and vaccinated in the study. |
| Arm/Group Title | Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years | Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years | Fluzone High-Dose Vaccine Group 3: ≥ 65 Years |
|---|---|---|---|
| Arm/Group Description | Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. | Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. |
| Period Title: Overall Study | |||
| STARTED | 60 | 60 | 60 |
| COMPLETED | 60 | 60 | 60 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years | Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years | Fluzone High-Dose Vaccine Group 3: ≥ 65 Years | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. | Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. | Total of all reporting groups |
| Overall Participants | 60 | 60 | 60 | 180 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
6.03
(1.61)
|
42.2
(12.9)
|
72.6
(6.19)
|
40.3
(28.5)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
26
43.3%
|
42
70%
|
45
75%
|
113
62.8%
|
| Male |
34
56.7%
|
18
30%
|
15
25%
|
67
37.2%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
60
100%
|
60
100%
|
60
100%
|
180
100%
|
Outcome Measures
| Title | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) |
|---|---|
| Description | Solicited injection site reactions: Pain (Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities), erythema & swelling (Grade 1: >0 to <25 mm;Grade 2: ≥ 25 to < 50 mm; Grade 3: ≥ 50 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise & myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site & systemic reactions are reported; number of participants with Grade 3 solicited injection-site & systemic reactions are also reported. |
| Time Frame | Within 7 days after any vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed using the Safety Analysis Set, which included all participants who received the study vaccine. Number of participants analyzed corresponds to participants with available data for the listed solicited reaction. |
| Arm/Group Title | Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years |
|---|---|
| Arm/Group Description | Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. |
| Measure Participants | 60 |
| Any Injection site pain |
18
30%
|
| Grade 3 Injection site pain |
1
1.7%
|
| Any Injection site erythema |
6
10%
|
| Grade3 Injection site erythema |
0
0%
|
| Any Injection site swelling |
7
11.7%
|
| Grade3 Injection site swelling |
0
0%
|
| Any Fever |
3
5%
|
| Grade 3 Fever |
1
1.7%
|
| Any Headache |
9
15%
|
| Grade 3 Headache |
0
0%
|
| Any Malaise |
15
25%
|
| Grade 3 Malaise |
1
1.7%
|
| Any Myalgia |
12
20%
|
| Grade 3 Myalgia |
0
0%
|
| Title | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years) |
|---|---|
| Description | Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant; prevents daily activity), erythema & swelling (Grade 1: ≥ 25 to ≤ 50 mm; Grade 2: ≥ 51 to ≤ 100 mm; Grade 3: >100 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise & myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site & systemic reactions are reported; number of participants with Grade 3 solicited injection-site & systemic reactions are also reported. |
| Time Frame | Within 7 days after any vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on safety analysis set. |
| Arm/Group Title | Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years | Fluzone High-Dose Vaccine Group 3: ≥ 65 Years |
|---|---|---|
| Arm/Group Description | Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. |
| Measure Participants | 60 | 60 |
| Any Injection site pain |
28
46.7%
|
12
20%
|
| Grade 3 Injection site pain |
0
0%
|
0
0%
|
| Any Injection site erythema |
0
0%
|
3
5%
|
| Grade3 Injection site erythema |
0
0%
|
0
0%
|
| Any Injection site swelling |
0
0%
|
1
1.7%
|
| Grade3 Injection site swelling |
0
0%
|
0
0%
|
| Any Fever |
0
0%
|
1
1.7%
|
| Grade 3 Fever |
0
0%
|
0
0%
|
| Any Headache |
11
18.3%
|
8
13.3%
|
| Grade 3 Headache |
0
0%
|
0
0%
|
| Any Malaise |
10
16.7%
|
4
6.7%
|
| Grade 3 Malaise |
0
0%
|
0
0%
|
| Any Myalgia |
15
25%
|
11
18.3%
|
| Grade 3 Myalgia |
0
0%
|
0
0%
|
| Title | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years) |
|---|---|
| Description | Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. |
| Time Frame | Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed using the Per-protocol Analysis Set (PPAS), which included all participants who received study vaccine and had a valid post-vaccination serology result for at least 1 strain. |
| Arm/Group Title | Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years |
|---|---|
| Arm/Group Description | Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. |
| Measure Participants | 54 |
| Pre-Vaccination: A/H1N1 |
273
|
| Pre-Vaccination: A/H3N2 |
167
|
| Pre-Vaccination: B Victoria |
111
|
| Pre-Vaccination: B Yamagata |
170
|
| Post-Vaccination: A/H1N1 |
1232
|
| Post-Vaccination: A/H3N2 |
2495
|
| Post-Vaccination: B Victoria |
1208
|
| Post-Vaccination: B Yamagata |
1731
|
| Title | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years) |
|---|---|
| Description | Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. |
| Time Frame | Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on PPAS. |
| Arm/Group Title | Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years |
|---|---|
| Arm/Group Description | Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. |
| Measure Participants | 60 |
| Pre-Vaccination: A/H1N1 |
225
|
| Pre-Vaccination: A/H3N2 |
66.1
|
| Pre-Vaccination: B Victoria |
195
|
| Pre-Vaccination: B Yamagata |
264
|
| Post-Vaccination: A/H1N1 |
779
|
| Post-Vaccination: A/H3N2 |
752
|
| Post-Vaccination: B Victoria |
998
|
| Post-Vaccination: B Yamagata |
1470
|
| Title | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years) |
|---|---|
| Description | Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 strains: H1N1, H3N2, Victoria lineage. |
| Time Frame | Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on PPAS. |
| Arm/Group Title | Fluzone High-Dose Vaccine Group 3: ≥ 65 Years |
|---|---|
| Arm/Group Description | Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. |
| Measure Participants | 60 |
| Pre-Vaccination: A/H1N1 |
77.3
|
| Pre-Vaccination: A/H3N2 |
59.6
|
| Pre-Vaccination: B Victoria |
106
|
| Post-Vaccination: A/H1N1 |
347
|
| Post-Vaccination: A/H3N2 |
590
|
| Post-Vaccination: B Victoria |
816
|
| Title | Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years) |
|---|---|
| Description | Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination. |
| Time Frame | Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on PPAS. |
| Arm/Group Title | Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years |
|---|---|
| Arm/Group Description | Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. |
| Measure Participants | 54 |
| Pre-Vaccination: A/H1N1 |
46
76.7%
|
| Pre-Vaccination: A/H3N2 |
47
78.3%
|
| Pre-Vaccination: B Victoria |
35
58.3%
|
| Pre-Vaccination: B Yamagata |
41
68.3%
|
| Post-Vaccination: A/H1N1 |
54
90%
|
| Post-Vaccination: A/H3N2 |
54
90%
|
| Post-Vaccination: B Victoria |
52
86.7%
|
| Post-Vaccination: B Yamagata |
53
88.3%
|
| Title | Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years) |
|---|---|
| Description | Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination. |
| Time Frame | Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on PPAS. |
| Arm/Group Title | Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years |
|---|---|
| Arm/Group Description | Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. |
| Measure Participants | 60 |
| Pre-Vaccination: A/H1N1 |
53
88.3%
|
| Pre-Vaccination: A/H3N2 |
40
66.7%
|
| Pre-Vaccination: B Victoria |
52
86.7%
|
| Pre-Vaccination: B Yamagata |
56
93.3%
|
| Post-Vaccination: A/H1N1 |
60
100%
|
| Post-Vaccination: A/H3N2 |
60
100%
|
| Post-Vaccination: B Victoria |
60
100%
|
| Post-Vaccination: B Yamagata |
60
100%
|
| Title | Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years) |
|---|---|
| Description | Anti-influenza antibodies were measured using HAI assay for 3 strains: H1N1, H3N2, Victoria lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination. |
| Time Frame | Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on PPAS. |
| Arm/Group Title | Fluzone High-Dose Vaccine Group 3: ≥ 65 Years |
|---|---|
| Arm/Group Description | Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. |
| Measure Participants | 60 |
| Pre-Vaccination: A/H1N1 |
41
68.3%
|
| Pre-Vaccination: A/H3N2 |
39
65%
|
| Pre-Vaccination: B Victoria |
51
85%
|
| Post-Vaccination: A/H1N1 |
56
93.3%
|
| Post-Vaccination: A/H3N2 |
58
96.7%
|
| Post-Vaccination: B Victoria |
60
100%
|
Adverse Events
| Time Frame | Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination. | |||||
| Arm/Group Title | Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years | Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years | Fluzone High-Dose Vaccine Group 3: ≥ 65 Years | |||
| Arm/Group Description | Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. | Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. | |||
All Cause Mortality |
||||||
| Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years | Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years | Fluzone High-Dose Vaccine Group 3: ≥ 65 Years | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) | |||
Serious Adverse Events |
||||||
| Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years | Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years | Fluzone High-Dose Vaccine Group 3: ≥ 65 Years | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/60 (1.7%) | 0/60 (0%) | 2/60 (3.3%) | |||
| Cardiac disorders | ||||||
| Atrial fibrillation | 0/60 (0%) | 0/60 (0%) | 1/60 (1.7%) | |||
| Infections and infestations | ||||||
| Pneumonia | 0/60 (0%) | 0/60 (0%) | 1/60 (1.7%) | |||
| Sepsis | 0/60 (0%) | 0/60 (0%) | 1/60 (1.7%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Musculoskeletal chest pain | 0/60 (0%) | 0/60 (0%) | 1/60 (1.7%) | |||
| Renal and urinary disorders | ||||||
| Acute kidney injury | 0/60 (0%) | 0/60 (0%) | 1/60 (1.7%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Asthma | 1/60 (1.7%) | 0/60 (0%) | 0/60 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years | Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years | Fluzone High-Dose Vaccine Group 3: ≥ 65 Years | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 35/60 (58.3%) | 33/60 (55%) | 25/60 (41.7%) | |||
| General disorders | ||||||
| Injection site erythema | 6/60 (10%) | 0/60 (0%) | 3/60 (5%) | |||
| Injection site pain | 18/60 (30%) | 28/60 (46.7%) | 12/60 (20%) | |||
| Injection site swelling | 7/60 (11.7%) | 0/60 (0%) | 1/60 (1.7%) | |||
| Malaise | 15/60 (25%) | 10/60 (16.7%) | 4/60 (6.7%) | |||
| Pyrexia | 5/60 (8.3%) | 0/60 (0%) | 1/60 (1.7%) | |||
| Infections and infestations | ||||||
| Bronchiolitis | 3/60 (5%) | 0/60 (0%) | 0/60 (0%) | |||
| Pharyngitis streptococcal | 4/60 (6.7%) | 0/60 (0%) | 0/60 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Myalgia | 12/60 (20%) | 15/60 (25%) | 12/60 (20%) | |||
| Nervous system disorders | ||||||
| Headache | 9/60 (15%) | 11/60 (18.3%) | 8/60 (13.3%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 6/60 (10%) | 0/60 (0%) | 0/60 (0%) | |||
| Oropharyngeal pain | 3/60 (5%) | 0/60 (0%) | 0/60 (0%) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Sanofi Pasteur Inc. |
| Phone | |
| RegistryContactUs@sanofipasteur.com |
- GRC71
- U1111-1174-4738