Influenza
Conditions
Brief summary
The primary objectives of this study were: * To describe the immunogenicity of the 2018-2019 formulation of Fluzone® Quadrivalent vaccine in children 6 to less than (\<) 36 months of age and 3 to \<9 years of age, and in adults 18 to \<65 years of age; the immunogenicity of the 2018-2019 formulation of Flublok® Quadrivalent vaccine in adults 18 to \<65 years of age; and the immunogenicity of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults greater than or equal to (\>=) 65 years of age. * To describe the safety of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in children 6 to \<36 months of age and 3 to \<9 years of age, and in adults 18 to \<65 years of age; the safety of the 2018-2019 formulation of Flublok Quadrivalent vaccine in adults 18 to \<65 years of age; and the safety of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults \>=65 years of age.
Detailed description
Study duration per participant was approximately 21 days for adult participants or 28 days for child participants who received one dose of vaccine, and 56 days for participants who received two doses of vaccine.
Interventions
BIOLOGICALFluzone Quadrivalent vaccine, 2018-2019 formulation
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICALFlublok Quadrivalent vaccine, 2018-2019 formulation
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICALFluzone High-Dose vaccine, 2018-2019 formulation
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The study was partially randomized. Participants were assigned a vaccine group based on age. Participants in Groups 1, 2, and 5 were not randomly assigned, while participants in Groups 3 and 4 were randomly assigned.
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 kilograms (kg) (5.5 pounds \[lbs.\]). * Informed consent form (ICF) 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 ICF had been signed and dated by parent(s) or guardian(s) for participants 6 months to \<9 years of age. * Participants 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. * Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 2 for participants who received 1 dose of influenza vaccine or Visit 3 for participants who received 2 doses of influenza vaccine. * Previous vaccination against influenza (in the 2018-2019 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. * Thrombocytopenia, which might 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 \[38.0 degree Celsius\]). A prospective participant was not included in the study until the condition had resolved or the febrile event had 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. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions | Within 7 days post any vaccination | A solicited reaction was an adverse event (AE) that was pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection (Inj.) site reactions: tenderness, erythema and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability. |
| Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Within 7 days post any vaccination | A solicited reaction was an AE that was pre-listed in the eCRF and considered to be related to vaccination. Solicited injection site reactions: pain, erythema and swelling. Solicited systemic reactions: fever, headache, malaise, and myalgia. |
| Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | 28 days post-final vaccination | GMT of anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. |
| Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | Day 21 (post-vaccination) | GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. |
| Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | Day 0 (pre-vaccination), 28 days post-final vaccination | GMT of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. GMTRs were calculated as the ratio of GMTs post-final vaccination and pre-vaccination. |
| Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | Day 0 (pre-vaccination), Day 21 (post-vaccination) | GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination. |
| Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2 | 28 days post-final vaccination | Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer \>=40 (1/ dilution) at pre-vaccination and at post-final vaccination. |
| Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | Day 21 (post-vaccination) | Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. Seroprotection was defined as antibody titer \>=40 (1/dilution) at pre-vaccination and at post-final vaccination. |
| Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2 | 28 days post-final vaccination | Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination titer \<10 (1/dilution) and a post-final vaccination titer \>= 40 (1/dilution) or a pre-vaccination titer \>= 10 (1/dilution) and \>=4-fold increase in post-final vaccination titer. |
| Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | Day 21 (post-vaccination) | Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Group 3 and 4, and using an HAI assay for 3 strains: A/H1N1, A/H3N2, and B Victoria lineage in Group 5. Seroconversion was defined as either a pre-vaccination titer \<10 (1/dilution) and a post-vaccination titer \>= 40 (1/dilution) or a pre-vaccination titer \>= 10 (1/dilution) and \>=4-fold increase in post-vaccination titer. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 10 September 2018 to 22 October 2018 at 3 centers in the United States.
Pre-assignment details
A total of 240 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months Participants (aged 6 to \<36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 30 |
| Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 30 |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | 61 |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0. | 59 |
| Fluzone High-Dose Vaccine Group 5: >=65 Years Participants (aged \>=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. | 60 |
| Total | 240 |
Baseline characteristics
| Characteristic | Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Total | Fluzone High-Dose Vaccine Group 5: >=65 Years | Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years |
|---|---|---|---|---|---|---|
| Age, Continuous | 1.7 years STANDARD_DEVIATION 0.44 | 42.6 years STANDARD_DEVIATION 26.97 | 73.6 years STANDARD_DEVIATION 6.42 | 46.2 years STANDARD_DEVIATION 13.44 | 46.7 years STANDARD_DEVIATION 13.48 | 5.9 years STANDARD_DEVIATION 1.76 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 54 Participants | 4 Participants | 12 Participants | 20 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 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 | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 180 Participants | 56 Participants | 46 Participants | 41 Participants | 19 Participants |
| Sex: Female, Male Female | 13 Participants | 152 Participants | 40 Participants | 42 Participants | 45 Participants | 12 Participants |
| Sex: Female, Male Male | 17 Participants | 88 Participants | 20 Participants | 17 Participants | 16 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 61 | 0 / 59 | 0 / 60 |
| other Total, other adverse events | 21 / 30 | 13 / 30 | 33 / 61 | 29 / 59 | 34 / 60 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 61 | 0 / 59 | 0 / 60 |
Outcome results
Primary
Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
GMT of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. GMTRs were calculated as the ratio of GMTs post-final vaccination and pre-vaccination.
Time frame: Day 0 (pre-vaccination), 28 days post-final vaccination
Population: Analysis was performed on per-protocol analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | A/H1N1(post-final vaccination/pre-vaccination) | 9.06 ratio |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | A/H3N2(post-final vaccination/pre-vaccination) | 3.94 ratio |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | B Victoria(post-final vaccination/pre-vaccination) | 8.11 ratio |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | B Yamagata(post-final vaccination/pre-vaccination) | 11.8 ratio |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | A/H3N2(post-final vaccination/pre-vaccination) | 6.40 ratio |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | A/H1N1(post-final vaccination/pre-vaccination) | 4.47 ratio |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | B Victoria(post-final vaccination/pre-vaccination) | 13.3 ratio |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | B Yamagata(post-final vaccination/pre-vaccination) | 8.41 ratio |
Primary
Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Time frame: Day 0 (pre-vaccination), Day 21 (post-vaccination)
Population: Analysis was performed on per-protocol analysis set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | B Victoria (post-vaccination/pre-vaccination) | 3.39 ratio |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | A/H3N2 (post-vaccination/pre-vaccination) | 3.55 ratio |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | A/H1N1 (post-vaccination/pre-vaccination) | 2.93 ratio |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | B Yamagata (post-vaccination/pre-vaccination) | 2.84 ratio |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | A/H3N2 (post-vaccination/pre-vaccination) | 8.19 ratio |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | A/H1N1 (post-vaccination/pre-vaccination) | 6.34 ratio |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | B Victoria (post-vaccination/pre-vaccination) | 4.40 ratio |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | B Yamagata (post-vaccination/pre-vaccination) | 5.20 ratio |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | B Victoria (post-vaccination/pre-vaccination) | 3.65 ratio |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | A/H3N2 (post-vaccination/pre-vaccination) | 3.69 ratio |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | A/H1N1 (post-vaccination/pre-vaccination) | 3.07 ratio |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | B Yamagata (post-vaccination/pre-vaccination) | NA ratio |
Primary
Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
GMT of anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage.
Time frame: 28 days post-final vaccination
Population: Analysis was performed on per-protocol analysis set which included participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result for at least 1 strain without any protocol deviations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | A/H1N1 | 229 titers (1/dilution) |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | A/H3N2 | 239 titers (1/dilution) |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | B Victoria | 160 titers (1/dilution) |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | B Yamagata | 295 titers (1/dilution) |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | B Yamagata | 1343 titers (1/dilution) |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | A/H1N1 | 1008 titers (1/dilution) |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | B Victoria | 688 titers (1/dilution) |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | A/H3N2 | 1109 titers (1/dilution) |
Primary
Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5.
Time frame: Day 21 (post-vaccination)
Population: Analysis was performed on per-protocol analysis set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | A/H3N2 | 379 titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | B Yamagata | 759 titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | A/H1N1 | 525 titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | B Victoria | 588 titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | A/H1N1 | 708 titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | A/H3N2 | 644 titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | B Victoria | 525 titers (1/dilutions) |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | B Yamagata | 1102 titers (1/dilutions) |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | B Yamagata | NA titers (1/dilutions) |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | B Victoria | 453 titers (1/dilutions) |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | A/H3N2 | 359 titers (1/dilutions) |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | A/H1N1 | 266 titers (1/dilutions) |
Primary
Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
A solicited reaction was an adverse event (AE) that was pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection (Inj.) site reactions: tenderness, erythema and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability.
Time frame: Within 7 days post any vaccination
Population: Analysis was performed on safety analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions | Injection site tenderness | 15 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions | Injection site erythema | 3 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions | Injection site swelling | 4 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions | Fever | 2 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions | Vomiting | 3 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions | Crying abnormal | 4 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions | Drowsiness | 9 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions | Appetite lost | 10 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions | Irritability | 12 Participants |
Primary
Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions
A solicited reaction was an AE that was pre-listed in the eCRF and considered to be related to vaccination. Solicited injection site reactions: pain, erythema and swelling. Solicited systemic reactions: fever, headache, malaise, and myalgia.
Time frame: Within 7 days post any vaccination
Population: Analysis was performed on safety analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Injection site erythema | 5 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Headache | 5 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Malaise | 6 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Injection site pain | 9 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Injection site swelling | 6 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Fever | 1 Participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Myalgia | 6 Participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Malaise | 11 Participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Fever | 0 Participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Headache | 12 Participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Myalgia | 14 Participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Injection site erythema | 1 Participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Injection site swelling | 2 Participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Injection site pain | 27 Participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Headache | 13 Participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Malaise | 6 Participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Myalgia | 11 Participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Injection site erythema | 0 Participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Injection site swelling | 0 Participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Fever | 0 Participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Injection site pain | 22 Participants |
| Fluzone High-Dose Vaccine Group 5: >=65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Injection site swelling | 3 Participants |
| Fluzone High-Dose Vaccine Group 5: >=65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Myalgia | 15 Participants |
| Fluzone High-Dose Vaccine Group 5: >=65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Injection site pain | 24 Participants |
| Fluzone High-Dose Vaccine Group 5: >=65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Injection site erythema | 5 Participants |
| Fluzone High-Dose Vaccine Group 5: >=65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Fever | 0 Participants |
| Fluzone High-Dose Vaccine Group 5: >=65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Headache | 11 Participants |
| Fluzone High-Dose Vaccine Group 5: >=65 Years | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | Malaise | 9 Participants |
Primary
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Group 3 and 4, and using an HAI assay for 3 strains: A/H1N1, A/H3N2, and B Victoria lineage in Group 5. Seroconversion was defined as either a pre-vaccination titer \<10 (1/dilution) and a post-vaccination titer \>= 40 (1/dilution) or a pre-vaccination titer \>= 10 (1/dilution) and \>=4-fold increase in post-vaccination titer.
Time frame: Day 21 (post-vaccination)
Population: Analysis was performed on per-protocol analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | B Yamagata | 27.9 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | A/H1N1 | 32.8 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | B Victoria | 32.8 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | A/H3N2 | 44.3 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | B Victoria | 46.6 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | B Yamagata | 55.2 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | A/H3N2 | 70.7 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | A/H1N1 | 51.7 percentage of participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | B Yamagata | NA percentage of participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | A/H3N2 | 50.0 percentage of participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | B Victoria | 46.7 percentage of participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | A/H1N1 | 46.7 percentage of participants |
Primary
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination titer \<10 (1/dilution) and a post-final vaccination titer \>= 40 (1/dilution) or a pre-vaccination titer \>= 10 (1/dilution) and \>=4-fold increase in post-final vaccination titer.
Time frame: 28 days post-final vaccination
Population: Analysis was performed on per-protocol analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2 | A/H1N1 | 80.0 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2 | A/H3N2 | 56.0 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2 | B Victoria | 80.0 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2 | B Yamagata | 88.0 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2 | B Yamagata | 78.6 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2 | A/H1N1 | 42.9 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2 | B Victoria | 92.9 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2 | A/H3N2 | 64.3 percentage of participants |
Primary
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. Seroprotection was defined as antibody titer \>=40 (1/dilution) at pre-vaccination and at post-final vaccination.
Time frame: Day 21 (post-vaccination)
Population: Analysis was performed on per-protocol analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | B Victoria | 100 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | B Yamagata | 100 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | A/H3N2 | 98.4 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | A/H1N1 | 100 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | A/H1N1 | 100 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | A/H3N2 | 100 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | B Yamagata | 100 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | B Victoria | 98.3 percentage of participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | B Yamagata | NA percentage of participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | B Victoria | 98.3 percentage of participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | A/H3N2 | 98.3 percentage of participants |
| Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | A/H1N1 | 93.3 percentage of participants |
Primary
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer \>=40 (1/ dilution) at pre-vaccination and at post-final vaccination.
Time frame: 28 days post-final vaccination
Population: Analysis was performed on per-protocol analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2 | B Victoria | 80.8 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2 | A/H1N1 | 84.6 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2 | B Yamagata | 92.3 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2 | A/H3N2 | 80.8 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2 | B Yamagata | 96.6 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2 | A/H3N2 | 96.6 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2 | B Victoria | 100 percentage of participants |
| Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2 | A/H1N1 | 96.6 percentage of participants |