Flu, Influenza
Conditions
Keywords
Influenza, Flu
Brief summary
The aim of the study was to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Quadrivalent vaccine in children 6 months to \< 9 years of age, and in adults 18 to \< 65 years of age, and to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
Detailed description
All participants received 1 intramuscular dose of their assigned vaccine during Visit 1. For participants, for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of the same volume as the first dose was administered during Visit 2 (28 days after Visit 1). Solicited adverse reaction (AR) information was collected for 7 days following each 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 (Day 28 post-final vaccination for participants 6 months to \< 9 years of age and Day 21 post-vaccination for participants ≥ 18 years of age).
Interventions
BIOLOGICALFluzone Quadrivalent vaccine
0.25 mL, Intramuscular
BIOLOGICALFluzone High-Dose vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Multicenter, Open-label, Phase IV Study
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 6 months to \< 9 years or ≥ 18 years 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 ≥ 2.5 kg (5.5 lbs). * Informed consent form has been signed and dated by participants ≥ 18 years of age. * Assent form was signed and dated by participants 7 to \< 9 years of age, and informed consent form has 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 to comply with all study 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 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 may 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 are planned before the participant would complete safety surveillance for the present study. * 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 2017-2018 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). * 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. Note: The list of vaccine components is included in the Prescribing Information for each study vaccine. * 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, 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 \[°F\] \[38.0 degrees Celsius {°C}\]). 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Within 7 days after any vaccination | Solicited injection site reactions: Pain, Erythema and Swelling (Grade 3: Pain: cries when injected limb moved/ limb movement reduced, erythema and swelling \>= 50 mm). Solicited systemic reactions: Fever, vomiting, abnormal crying, drowsiness, appetite lost, Irritability (Grade 3: Fever: \>= 39.5 degrees Celsius \[103.1 degree Fahrenheit {°F}\], vomiting \>= six episodes per 24 hours, abnormal crying : \> 3 hours, drowsiness: sleeping most of the time or difficult to wake up, appetite lost: refuses \>= 3 feeds/meals or refuses most feeds/meals, Irritability: Inconsolable). |
| Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Within 7 days after any vaccination | Solicited injection site reactions: Pain (Group 2: Grade 3: Incapacitating; Group 3 and 4: Grade 3: significant; prevents daily activity), erythema & swelling (Group 2: Grade 3: \>= 50 mm, Group 3 and 4: Grade 3: \> 100 mm). Solicited systemic reactions: Fever (Grade 3: \>= 39.0 degrees Celsius \[102.2°F\]), headache, malaise & myalgia (Grade 3: significant interference with daily activities). |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Day 0 (pre-vaccination) and Day 28 (post-vaccination) | Anti-influenza antibodies were measured using the hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. |
| GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Day 0 (pre-vaccination) and Day 21 (post-vaccination) | Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). |
| GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Day 0 (pre-vaccination) and Day 28 (post-final vaccination) | GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage, measured using the HAI assay. |
| GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Day 0 (pre-vaccination) and Day 21 (post-vaccination) | GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4), measured using the HAI assay. |
| Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Day 0 (pre-vaccination) and Day 28 (post-vaccination) | Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer \>=40 (1/ dilution) at pre-vaccination or at post-final vaccination. |
| Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Day 0 (pre-vaccination) and Day 21 (post-vaccination) | Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroprotection was defined as antibody titer \>= 40 (1/ dilution) at pre-vaccination or at post-final vaccination. |
| Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Day 0 (pre-vaccination) and Day 28 (post-final vaccination) | Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-final vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-final vaccination titer. |
| Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Day 0 (pre-vaccination) and Day 21 (post-vaccination) | Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-final vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-final vaccination titer. |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled in 3 centers in the United States from 11 September 2017 to 25 October 2017.
Pre-assignment details
A total of 240 participants were enrolled and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: 6 to < 36 Months Children aged 6 to \< 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28. | 59 |
| Group 2: 3 to < 9 Years Children 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, a second dose was administered on Day 28. | 61 |
| Group 3: 18 to < 65 Years Adults aged 18 to \< 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | 60 |
| Group 4: >= 65 Years Adults aged \>= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. | 60 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1: 6 to < 36 Months | Group 2: 3 to < 9 Years | Group 3: 18 to < 65 Years | Group 4: >= 65 Years | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 59 Participants | 61 Participants | 1 Participants | 0 Participants | 121 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 60 Participants | 60 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 59 Participants | 0 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 0 Participants | 1 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 55 Participants | 60 Participants | 59 Participants | 230 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 30 Participants | 16 Participants | 5 Participants | 80 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 6 Participants | 1 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 25 Participants | 43 Participants | 53 Participants | 150 Participants |
| Sex: Female, Male Female | 25 Participants | 31 Participants | 46 Participants | 39 Participants | 141 Participants |
| Sex: Female, Male Male | 34 Participants | 30 Participants | 14 Participants | 21 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 61 | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 30 / 59 | 30 / 61 | 29 / 60 | 30 / 60 |
| serious Total, serious adverse events | 0 / 59 | 0 / 61 | 2 / 60 | 0 / 60 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Anti-influenza antibodies were measured using the hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage.
Time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Population: Per-Protocol Analysis Set (PPAS) included all participants who received at least 1dose of study vaccine, had a valid post-final vaccination serology result for at least 1 strain and did not have any major protocol deviations. Here, Number analyzed corresponds to participants with available data for each listed strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: 6 to < 36 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: A/H1N1 | 19.9 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: A/H3N2 | 49.7 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: B Victoria | 32.0 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: B Yamagata | 43.5 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: A/H1N1 | 450 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: A/H3N2 | 568 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: B Victoria | 481 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: B Yamagata | 698 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: B Yamagata | 2187 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: A/H1N1 | 306 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: A/H1N1 | 1606 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: A/H3N2 | 415 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: B Victoria | 1668 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: B Victoria | 180 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: A/H3N2 | 2370 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: B Yamagata | 334 Titers (1/dilutions) |
Primary
GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage, measured using the HAI assay.
Time frame: Day 0 (pre-vaccination) and Day 28 (post-final vaccination)
Population: Analysis was performed on PPAS. Here, Number analyzed corresponds to participants with available data for each listed strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: 6 to < 36 Months | GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | A/H1N1 | 17.6 Titer Ratio |
| Group 1: 6 to < 36 Months | GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | A/H3N2 | 10.8 Titer Ratio |
| Group 1: 6 to < 36 Months | GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | B Victoria | 13.1 Titer Ratio |
| Group 1: 6 to < 36 Months | GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | B Yamagata | 14.0 Titer Ratio |
| Group 3: 18 to < 65 Years | GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | B Yamagata | 6.46 Titer Ratio |
| Group 3: 18 to < 65 Years | GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | A/H1N1 | 5.05 Titer Ratio |
| Group 3: 18 to < 65 Years | GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | B Victoria | 9.02 Titer Ratio |
| Group 3: 18 to < 65 Years | GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | A/H3N2 | 5.54 Titer Ratio |
Primary
GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4), measured using the HAI assay.
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Population: Analysis was performed on PPAS. Here, Number analyzed corresponds to participants with available data for each listed strain and 0 in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: 6 to < 36 Months | GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | B Victoria | 4.05 Titer Ratio |
| Group 1: 6 to < 36 Months | GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | A/H3N2 | 4.44 Titer Ratio |
| Group 1: 6 to < 36 Months | GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | B Yamagata | 3.09 Titer Ratio |
| Group 1: 6 to < 36 Months | GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | A/H1N1 | 4.31 Titer Ratio |
| Group 3: 18 to < 65 Years | GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | A/H3N2 | 4.45 Titer Ratio |
| Group 3: 18 to < 65 Years | GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | A/H1N1 | 5.15 Titer Ratio |
| Group 3: 18 to < 65 Years | GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | B Victoria | 2.96 Titer Ratio |
Primary
GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4).
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Population: Analysis was performed on PPAS. Here, Number analyzed corresponds to participants with available data for each listed strain and 0 in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: 6 to < 36 Months | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: B Yamagata | 1312 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: B Victoria | 276 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: B Yamagata | 425 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: A/H1N1 | 756 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: A/H3N2 | 1128 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: B Victoria | 1117 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: A/H1N1 | 165 Titers (1/dilutions) |
| Group 1: 6 to < 36 Months | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: A/H3N2 | 231 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: A/H1N1 | 74.6 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: A/H3N2 | 864 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: A/H3N2 | 194 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: A/H1N1 | 393 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: B Victoria | 215 Titers (1/dilutions) |
| Group 3: 18 to < 65 Years | GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: B Victoria | 644 Titers (1/dilutions) |
Primary
Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years)
Solicited injection site reactions: Pain (Group 2: Grade 3: Incapacitating; Group 3 and 4: Grade 3: significant; prevents daily activity), erythema & swelling (Group 2: Grade 3: \>= 50 mm, Group 3 and 4: Grade 3: \> 100 mm). Solicited systemic reactions: Fever (Grade 3: \>= 39.0 degrees Celsius \[102.2°F\]), headache, malaise & myalgia (Grade 3: significant interference with daily activities).
Time frame: Within 7 days after any vaccination
Population: Analysis was performed using Safety Analysis Set. Here, Number analyzed corresponds to participants with available data for each listed solicited reaction.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Malaise | 3 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Swelling : Grade 3 | 2 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Erythema | 9 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Headache : Grade 3 | 0 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Fever | 1 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Pain: Grade 3 | 1 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Headache | 2 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Fever : Grade 3 | 1 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Malaise: Grade 3 | 1 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Erythema : Grade 3 | 3 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Myalgia : Grade 3 | 0 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Pain | 25 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Swelling | 11 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Myalgia | 11 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Malaise | 5 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Pain | 27 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Pain: Grade 3 | 1 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Erythema | 0 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Erythema : Grade 3 | 0 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Swelling | 1 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Swelling : Grade 3 | 0 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Fever | 0 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Fever : Grade 3 | 0 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Headache | 10 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Headache : Grade 3 | 1 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Malaise: Grade 3 | 1 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Myalgia | 13 Participants |
| Group 3: 18 to < 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Myalgia : Grade 3 | 1 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Myalgia | 17 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Headache : Grade 3 | 0 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Swelling | 2 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Erythema : Grade 3 | 0 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Malaise | 9 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Erythema | 3 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Pain | 20 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Malaise: Grade 3 | 0 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Pain: Grade 3 | 0 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Fever : Grade 3 | 1 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Fever | 1 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Myalgia : Grade 3 | 1 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Headache | 6 Participants |
| Group 4: >= 65 Years | Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years) | Swelling : Grade 3 | 0 Participants |
Primary
Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months)
Solicited injection site reactions: Pain, Erythema and Swelling (Grade 3: Pain: cries when injected limb moved/ limb movement reduced, erythema and swelling \>= 50 mm). Solicited systemic reactions: Fever, vomiting, abnormal crying, drowsiness, appetite lost, Irritability (Grade 3: Fever: \>= 39.5 degrees Celsius \[103.1 degree Fahrenheit {°F}\], vomiting \>= six episodes per 24 hours, abnormal crying : \> 3 hours, drowsiness: sleeping most of the time or difficult to wake up, appetite lost: refuses \>= 3 feeds/meals or refuses most feeds/meals, Irritability: Inconsolable).
Time frame: Within 7 days after any vaccination
Population: Analysis was performed using the Safety Analysis Set. Here, Number analyzed corresponds to participants with available data for each listed solicited reaction.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Tenderness | 16 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Tenderness : Grade 3 | 1 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Erythema | 4 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Erythema : Grade 3 | 0 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Swelling | 2 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Swelling : Grade 3 | 0 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Fever | 6 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Fever : Grade 3 | 0 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Vomiting | 2 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Vomiting : Grade 3 | 0 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Crying Abnormal | 10 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Crying Abnormal : Grade 3 | 0 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Drowsiness | 11 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Drowsiness : Grade 3 | 0 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Appetite Lost | 7 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Appetite Lost : Grade 3 | 0 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Irritability | 13 Participants |
| Group 1: 6 to < 36 Months | Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) | Irritability : Grade 3 | 0 Participants |
Primary
Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-final vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-final vaccination titer.
Time frame: Day 0 (pre-vaccination) and Day 28 (post-final vaccination)
Population: Analysis was performed on PPAS. Here, Number analyzed corresponds to participants with available data for each listed strain.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: 6 to < 36 Months | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | A/H1N1 | 45 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | A/H3N2 | 42 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | B Victoria | 44 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | B Yamagata | 46 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | B Yamagata | 36 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | A/H1N1 | 28 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | B Victoria | 39 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | A/H3N2 | 30 Participants |
Primary
Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-final vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-final vaccination titer.
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Population: Analysis was performed on PPAS. Here, Number analyzed corresponds to participants with available data for each listed strain and 0 in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: 6 to < 36 Months | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | B Victoria | 19 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | A/H3N2 | 22 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | B Yamagata | 22 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | A/H1N1 | 26 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | A/H3N2 | 33 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | A/H1N1 | 33 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | B Victoria | 18 Participants |
Primary
Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer \>=40 (1/ dilution) at pre-vaccination or at post-final vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Population: Analysis was performed on PPAS. Here, Number analyzed corresponds to participants with available data for each listed strain.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: A/H1N1 | 15 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: A/H3N2 | 24 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: B Victoria | 21 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: B Yamagata | 31 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: A/H1N1 | 51 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: A/H3N2 | 50 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: B Victoria | 50 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: B Yamagata | 50 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: B Yamagata | 55 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: A/H1N1 | 48 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: A/H1N1 | 54 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: A/H3N2 | 46 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: B Victoria | 54 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: B Victoria | 44 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Post-Final Vaccination: A/H3N2 | 54 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years) | Pre-Vaccination: B Yamagata | 50 Participants |
Primary
Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroprotection was defined as antibody titer \>= 40 (1/ dilution) at pre-vaccination or at post-final vaccination.
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Population: Analysis was performed on PPAS. Here, Number analyzed corresponds to participants with available data for each listed strain and 0 in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: B Yamagata | 56 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: B Victoria | 48 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: B Yamagata | 54 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: A/H1N1 | 55 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: A/H3N2 | 55 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: B Victoria | 56 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: A/H1N1 | 45 Participants |
| Group 1: 6 to < 36 Months | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: A/H3N2 | 48 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: A/H1N1 | 40 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: A/H3N2 | 59 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: A/H3N2 | 49 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: A/H1N1 | 57 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Pre-Vaccination: B Victoria | 55 Participants |
| Group 3: 18 to < 65 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years) | Post-Final Vaccination: B Victoria | 58 Participants |