Influenza
Conditions
Brief summary
The objectives of this study were: * To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including adverse events of special interest throughout the study). * To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by hemagglutination inhibition (HAI) measurement method. * To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement method. * To describe the antibody response induced by the highest acceptable dosage of QIV-HD compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN measurement methods.
Detailed description
Study duration per participant was approximately 180 days for participants who received one dose of vaccine and 208 days for participants who received two doses of vaccine.
Interventions
BIOLOGICALHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
BIOLOGICALHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
BIOLOGICALHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
BIOLOGICALFluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated)
Pharmaceutical form: Solution for injection Route of administration: IM
BIOLOGICALFLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated)
Pharmaceutical form: Solution for injection Route of administration: IM
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Modified double-blind: the participant's parent / legally acceptable representative, the Investigator, and other study personnel remained unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator administered the appropriate vaccine but was not involved in safety data collection.
Intervention model description
The study was divided into 13 groups and enrolled participants in 4 stages. The study used a stepwise age de-escalation and dose ascension design for children 6 months to less than (\<) 5 years of age.
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged 6 months to 17 years on the day of inclusion. * Assent form was signed and dated by the participant (7 to 17 years of age) and informed consent form was signed and dated by the parent(s) or guardian(s) and by an independent witness, if required by local regulations. * Participant and parent/guardian were able to attend all scheduled visits and complied with all study procedures. * For participants aged \<24 months: Born at full term of pregnancy (greater than or equal to \[\>=\] 37 weeks) and/or with a birth weight \>=2.5 kilogram.
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 until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche. * Participation at the time of study enrollment (or in the 4 weeks 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 3 for participants receiving 1 dose of influenza vaccine or Visit 5 for participants receiving 2 doses of influenza vaccine. * For previously influenza vaccinated participants: Previous vaccination against influenza in the preceding 6 months with either the study vaccine or another vaccine. * For previously influenza unvaccinated participants: Any influenza vaccination (from birth to the day of inclusion) with either the study vaccine or another influenza vaccine. * For previously influenza unvaccinated participants: Any previous laboratory confirmed influenza infection (from birth to the day of inclusion) * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. * Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgement. * 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 vaccination or febrile illness (temperature \>=38.0°Celsius \[\>=100.4°Fahrenheit\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * Identified as an immediate family member (i.e., spouse, natural or adopted child, grandchild, nephew, or niece) of the Investigator or employee with direct involvement in the proposed study. * 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 development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder. * Known seropositivity for 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 With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination | Within 30 minutes after any vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious (SAEs) and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. |
| Number of Participants With Unsolicited Adverse Events After Any Vaccination | Within 28 days after any vaccination | An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Adverse reactions (ARs) were AEs related to vaccination. An injection site reaction was an AR at and around the injection site. Systemic AEs were all AEs that were not injection or administration site reactions. |
| Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | From Day 0 up to 6 months (i.e. 180 days) post last vaccination | An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) were defined as SAEs which included new onset of Guillain-Barré syndrome, encephalitis/myelitis (including transverse myelitis), Bell's palsy, convulsions, optic neuritis, and brachial neuritis. |
| Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | Day 28 post any vaccination | Anti-influenza antibodies were measured by hemagglutination inhibition (HAI) assay for strains A/H1N1, A/H3N2, B/Victoria and B/Yamagata lineage. Seroconversion: defined as either HAI titer \<10(1/dilution) at Day 0 and post-vaccination titer greater than or equal to (\>=)40(1/dilution) at Day 28, or HAI titer \>=10(1/dilution) at Day 0 and \>=4-fold increase in HAI titer (1/dilution) at Day 28. Data for this Outcome Measure (OM) was planned to be collected and reported for dose level (QIV-HD 30μg and 45μg) matched separate groups for QIV-SD (Groups 4a, 4b and 4c), instead of pooled QIV-SD arm. Due to complex study design and analysis of doses and age groups, QIV-SD group participants, who matched to participants in QIV-HD 30μg and 45μg dose formulations groups (who were 9 through 17 years old and shared matching age group with QIV-SD control group), included in Groups 4a, 4b and 4c in this OM might be counted in more than once in QIV-SD arms for different dose levels, as applicable. |
| Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | Day 28 post any 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. Data for this OM was planned to be collected and reported for dose level (QIV-HD 30 μg and QIV-HD 45 μg) matched separate groups for QIV-SD (Groups 4a, 4b and 4c), instead of pooled QIV-SD arm. Due to the complex study design and analysis of the dose formulation and age groups in the study, QIV-SD group participants, who matched to participants in the QIV-HD 30 μg and QIV-HD 45 μg dose formulations groups (who were 9 through 17 years old and shared a matching age group with QIV-SD control group), included in Groups 4a, 4b and 4c in this OM might be counted in more than once in QIV-SD arms for different dose levels, as applicable. |
| Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | Day 0 (pre-vaccination), Day 28 (post any 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. GMTRs were calculated as the ratio of GMTs post-vaccination and pre-vaccination. |
| Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | Day 28 post any vaccination | GMT was measured for each influenza strain using HAI assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage. |
| Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | Day 28 post any vaccination | GMT was measured for each influenza strain using SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage. |
| Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | Day 0 (pre-vaccination), Day 28 (post any vaccination) | GMTRs of anti-influenza antibodies were measured using SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage and B/Yamagata lineage. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination. |
| Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | Day 28 post any vaccination | Neutralizing Antibody titer was measured for each influenza strain with SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage at pre-defined thresholds of \>=20, \>=40 and \>=80 (1/dilution). |
| Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | Day 28 post any vaccination | Neutralizing Antibody titer was measured for each influenza strain with SN method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage. 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / pre-vaccination computed value. |
| Number of Participants With Solicited Injection Site Reactions | Within 7 days after any vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions included tenderness/pain, erythema, swelling, induration and bruising. |
| Number of Participants With Solicited Systemic Reactions After Any Vaccination | Within 7 days after any vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability. Fever was planned to be evaluated for the whole population where as, the other events (vomiting, crying abnormal, drowsiness, appetite lost, and irritability) were planned to be evaluated only in the participants aged 6 months to \<36 months. |
| Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Within 7 days after any vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited systemic reactions included: headache, malaise, myalgia and shivering. |
Countries
Canada, United States
Participant flow
Recruitment details
The study was conducted at 16 centers in United States (US) and Canada from 09 October 2018 to 16 October 2019.
Pre-assignment details
A total of 665 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) Participants from US (aged 6 months to 17 years) received single injection of 30 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 124 |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) Participants from US (aged 6 months to 17 years) received single injection of 45 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 122 |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) Participants from US (aged 6 months to 17 years) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 159 |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) Pooled arm consisted of participants who were from US aged 6 months to 17 years, randomized to Groups 1, 2 and 3 and received single injection of 15 μg unadjuvanted QIV-SD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 234 |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) Participants from Canada (aged 6 to \<24 months) received single injection of 60 μg QIV-HD, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 13 |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) Participants from Canada (aged 6 to \<24 months) received single injection of 7.5 μg adjuvanted TIV, IM at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | 13 |
| Total | 665 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 | 4 | 5 | 0 | 0 |
| Overall Study | Protocol deviation | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by parent/guardian | 1 | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 6.1 years STANDARD_DEVIATION 4.3 | 5.2 years STANDARD_DEVIATION 4.22 | 5.1 years STANDARD_DEVIATION 4.02 | 0.8 years STANDARD_DEVIATION 0.19 | 1.0 years STANDARD_DEVIATION 0.28 | 5.8 years STANDARD_DEVIATION 3.91 | 5.3 years STANDARD_DEVIATION 4.13 |
| Age, Customized 36 months - < 5 years | 30 Participants | 44 Participants | 68 Participants | 0 Participants | 0 Participants | 34 Participants | 176 Participants |
| Age, Customized 5 - 8 years | 32 Participants | 31 Participants | 49 Participants | 0 Participants | 0 Participants | 32 Participants | 144 Participants |
| Age, Customized 6 - < 24 months | 0 Participants | 0 Participants | 0 Participants | 13 Participants | 13 Participants | 0 Participants | 26 Participants |
| Age, Customized 6 - < 36 months | 30 Participants | 54 Participants | 75 Participants | 0 Participants | 0 Participants | 29 Participants | 188 Participants |
| Age, Customized 9 - 17 years | 30 Participants | 30 Participants | 42 Participants | 0 Participants | 0 Participants | 29 Participants | 131 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 40 Participants | 58 Participants | 2 Participants | 0 Participants | 22 Participants | 150 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 8 Participants | 7 Participants | 2 Participants | 1 Participants | 4 Participants | 25 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 2 Participants | 5 Participants | 0 Participants | 1 Participants | 0 Participants | 11 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) White | 81 Participants | 108 Participants | 157 Participants | 9 Participants | 11 Participants | 92 Participants | 458 Participants |
| Sex: Female, Male Female | 61 Participants | 82 Participants | 114 Participants | 4 Participants | 6 Participants | 51 Participants | 318 Participants |
| Sex: Female, Male Male | 61 Participants | 77 Participants | 120 Participants | 9 Participants | 7 Participants | 73 Participants | 347 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 122 | 0 / 121 | 0 / 158 | 0 / 234 | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 101 / 122 | 100 / 121 | 118 / 158 | 165 / 234 | 13 / 13 | 13 / 13 |
| serious Total, serious adverse events | 0 / 122 | 0 / 121 | 2 / 158 | 0 / 234 | 0 / 13 | 1 / 13 |
Outcome results
Primary
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza 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. GMTRs were calculated as the ratio of GMTs post-vaccination and pre-vaccination.
Time frame: Day 0 (pre-vaccination), Day 28 (post any vaccination)
Population: Analysis was performed on IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28/Day 0 | 8.55 ratio |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28/Day 0 | 6.42 ratio |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28/Day 0 | 10.7 ratio |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28/Day 0 | 9.28 ratio |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28/Day 0 | 11.7 ratio |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28/Day 0 | 9.35 ratio |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28/Day 0 | 10.0 ratio |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28/Day 0 | 11.4 ratio |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28/Day 0 | 18.1 ratio |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28/Day 0 | 16.7 ratio |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28/Day 0 | 10.3 ratio |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28/Day 0 | 16.3 ratio |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28/Day 0 | 10.1 ratio |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28/Day 0 | 9.77 ratio |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28/Day 0 | 4.61 ratio |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28/Day 0 | 11.0 ratio |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28/Day 0 | 1.37 ratio |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28/Day 0 | 1.71 ratio |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28/Day 0 | 1.41 ratio |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28/Day 0 | 1.41 ratio |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28/Day 0 | 15.5 ratio |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28/Day 0 | 11.0 ratio |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28/Day 0 | 0.944 ratio |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28/Day 0 | 4.76 ratio |
Primary
Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza 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. Data for this OM was planned to be collected and reported for dose level (QIV-HD 30 μg and QIV-HD 45 μg) matched separate groups for QIV-SD (Groups 4a, 4b and 4c), instead of pooled QIV-SD arm. Due to the complex study design and analysis of the dose formulation and age groups in the study, QIV-SD group participants, who matched to participants in the QIV-HD 30 μg and QIV-HD 45 μg dose formulations groups (who were 9 through 17 years old and shared a matching age group with QIV-SD control group), included in Groups 4a, 4b and 4c in this OM might be counted in more than once in QIV-SD arms for different dose levels, as applicable.
Time frame: Day 28 post any vaccination
Population: Analysis was performed on IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 673 titers (1/dilution) |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 518 titers (1/dilution) |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 378 titers (1/dilution) |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 723 titers (1/dilution) |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 720 titers (1/dilution) |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 781 titers (1/dilution) |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 676 titers (1/dilution) |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 432 titers (1/dilution) |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 834 titers (1/dilution) |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 877 titers (1/dilution) |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 770 titers (1/dilution) |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 494 titers (1/dilution) |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 698 titers (1/dilution) |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 314 titers (1/dilution) |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 296 titers (1/dilution) |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 706 titers (1/dilution) |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 727 titers (1/dilution) |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 468 titers (1/dilution) |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 441 titers (1/dilution) |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 791 titers (1/dilution) |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 580 titers (1/dilution) |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 310 titers (1/dilution) |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 307 titers (1/dilution) |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 618 titers (1/dilution) |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 75.8 titers (1/dilution) |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 59.7 titers (1/dilution) |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 56.6 titers (1/dilution) |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 66.4 titers (1/dilution) |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 604 titers (1/dilution) |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 1244 titers (1/dilution) |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 21.8 titers (1/dilution) |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 604 titers (1/dilution) |
Primary
Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine
GMT was measured for each influenza strain using SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage.
Time frame: Day 28 post any vaccination
Population: Analysis was performed on the IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 6589 titers (1/dilution) |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 641 titers (1/dilution) |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 500 titers (1/dilution) |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 1147 titers (1/dilution) |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 605 titers (1/dilution) |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 921 titers (1/dilution) |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 6213 titers (1/dilution) |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 1159 titers (1/dilution) |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 1254 titers (1/dilution) |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 628 titers (1/dilution) |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 884 titers (1/dilution) |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 7045 titers (1/dilution) |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 4948 titers (1/dilution) |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 846 titers (1/dilution) |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 411 titers (1/dilution) |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 378 titers (1/dilution) |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 6.05 titers (1/dilution) |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 17.6 titers (1/dilution) |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 54.4 titers (1/dilution) |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 33.8 titers (1/dilution) |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 188 titers (1/dilution) |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 57.9 titers (1/dilution) |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 17.4 titers (1/dilution) |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers of Influenza Antibodies (Measured by Seroneutralization [SN] Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 234 titers (1/dilution) |
Primary
Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine
GMTRs of anti-influenza antibodies were measured using SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage and B/Yamagata lineage. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Time frame: Day 0 (pre-vaccination), Day 28 (post any vaccination)
Population: Analysis was performed on IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28/Day 0 | 11.3 ratio |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28/Day 0 | 3.60 ratio |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28/Day 0 | 12.4 ratio |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28/Day 0 | 9.75 ratio |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28/Day 0 | 15.4 ratio |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28/Day 0 | 5.20 ratio |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28/Day 0 | 18.8 ratio |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28/Day 0 | 11.5 ratio |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28/Day 0 | 14.1 ratio |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28/Day 0 | 19.9 ratio |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28/Day 0 | 5.54 ratio |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28/Day 0 | 29.1 ratio |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28/Day 0 | 14.5 ratio |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28/Day 0 | 8.49 ratio |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28/Day 0 | 2.66 ratio |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28/Day 0 | 12.7 ratio |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28/Day 0 | 1.03 ratio |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28/Day 0 | 1.16 ratio |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28/Day 0 | 1.04 ratio |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28/Day 0 | 2.38 ratio |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28/Day 0 | 2.81 ratio |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28/Day 0 | 10.5 ratio |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28/Day 0 | 1.10 ratio |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Geometric Mean Titers Ratio of Influenza Antibodies (Measured by Seroneutralization Assay) Following Vaccination With Either High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28/Day 0 | 7.12 ratio |
Primary
Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine
Anti-influenza antibodies were measured by hemagglutination inhibition (HAI) assay for strains A/H1N1, A/H3N2, B/Victoria and B/Yamagata lineage. Seroconversion: defined as either HAI titer \<10(1/dilution) at Day 0 and post-vaccination titer greater than or equal to (\>=)40(1/dilution) at Day 28, or HAI titer \>=10(1/dilution) at Day 0 and \>=4-fold increase in HAI titer (1/dilution) at Day 28. Data for this Outcome Measure (OM) was planned to be collected and reported for dose level (QIV-HD 30μg and 45μg) matched separate groups for QIV-SD (Groups 4a, 4b and 4c), instead of pooled QIV-SD arm. Due to complex study design and analysis of doses and age groups, QIV-SD group participants, who matched to participants in QIV-HD 30μg and 45μg dose formulations groups (who were 9 through 17 years old and shared matching age group with QIV-SD control group), included in Groups 4a, 4b and 4c in this OM might be counted in more than once in QIV-SD arms for different dose levels, as applicable.
Time frame: Day 28 post any vaccination
Population: Analysis was performed on immunogenicity analysis set (IAS) population which included randomized participants who received 1 dose or 2 doses of study vaccine and had a post-vaccination blood sample. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 72 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 63 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 84 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 79 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 85 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 79 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 71 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 94 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 107 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 120 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 102 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 117 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 26 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 18 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 28 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 26 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 31 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 30 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 20 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 24 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 117 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 111 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 71 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 98 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 8 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 8 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 6 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 8 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2 | 12 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria | 12 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata | 1 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1 | 11 Participants |
Primary
Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious (SAEs) and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Time frame: Within 30 minutes after any vaccination
Population: Analysis was performed on SafAS population which included participants who had received at least one dose of the study vaccines.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination | 0 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination | 0 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination | 1 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination | 0 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination | 0 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Any Vaccination | 0 Participants |
Primary
Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine
GMT was measured for each influenza strain using HAI assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage.
Time frame: Day 28 post any vaccination
Population: Analysis was performed on the IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28 | 113 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28 | 111 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28 | 112 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28 | 115 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28 | 108 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28 | 110 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28 | 110 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28 | 109 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28 | 142 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28 | 140 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28 | 139 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28 | 142 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28 | 198 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28 | 215 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28 | 198 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28 | 202 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28 | 0 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28 | 1 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28 | 0 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28 | 0 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H3N2: Day 28 | 9 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Victoria: Day 28 | 9 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | B/Yamagata: Day 28 | 1 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers >= 40 (1/Dilution) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or Standard-Dose Quadrivalent Influenza Vaccine or Adjuvanted Trivalent Influenza Vaccine | A/H1N1: Day 28 | 7 Participants |
Primary
Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds
Neutralizing Antibody titer was measured for each influenza strain with SN assay method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage at pre-defined thresholds of \>=20, \>=40 and \>=80 (1/dilution).
Time frame: Day 28 post any vaccination
Population: Analysis was performed on the IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=80 (1/dilution) | 99 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=20 (1/dilution) | 112 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=40 (1/dilution) | 108 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=80 (1/dilution) | 110 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=80 (1/dilution) | 111 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=40 (1/dilution) | 111 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=20 (1/dilution) | 113 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=40 (1/dilution) | 111 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=20 (1/dilution) | 111 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=80 (1/dilution) | 107 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=40 (1/dilution) | 112 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=20 (1/dilution) | 110 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=80 (1/dilution) | 107 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=20 (1/dilution) | 108 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=80 (1/dilution) | 99 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=40 (1/dilution) | 112 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=40 (1/dilution) | 111 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=20 (1/dilution) | 111 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=20 (1/dilution) | 112 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=40 (1/dilution) | 104 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=40 (1/dilution) | 108 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=80 (1/dilution) | 111 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=80 (1/dilution) | 103 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=20 (1/dilution) | 112 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=40 (1/dilution) | 145 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=80 (1/dilution) | 146 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=80 (1/dilution) | 128 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=20 (1/dilution) | 142 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=80 (1/dilution) | 140 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=20 (1/dilution) | 146 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=20 (1/dilution) | 143 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=40 (1/dilution) | 136 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=40 (1/dilution) | 141 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=40 (1/dilution) | 147 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=20 (1/dilution) | 147 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=80 (1/dilution) | 138 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=40 (1/dilution) | 195 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=20 (1/dilution) | 208 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=40 (1/dilution) | 202 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=80 (1/dilution) | 201 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=20 (1/dilution) | 214 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=40 (1/dilution) | 208 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=80 (1/dilution) | 190 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=20 (1/dilution) | 201 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=80 (1/dilution) | 181 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=20 (1/dilution) | 213 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=40 (1/dilution) | 208 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=80 (1/dilution) | 201 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=40 (1/dilution) | 13 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=80 (1/dilution) | 11 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=20 (1/dilution) | 13 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=80 (1/dilution) | 7 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=40 (1/dilution) | 9 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=20 (1/dilution) | 13 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=40 (1/dilution) | 12 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=80 (1/dilution) | 6 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=20 (1/dilution) | 13 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=20 (1/dilution) | 9 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=40 (1/dilution) | 8 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=80 (1/dilution) | 11 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=40 (1/dilution) | 11 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=40 (1/dilution) | 11 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=80 (1/dilution) | 11 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=20 (1/dilution) | 11 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=80 (1/dilution) | 2 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=20 (1/dilution) | 10 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=80 (1/dilution) | 11 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=40 (1/dilution) | 11 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Yamagata: >=40 (1/dilution) | 6 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H1N1: >=20 (1/dilution) | 11 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | B/Victoria: >=20 (1/dilution) | 11 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Neutralization Antibody Titers Above Pre-Defined Thresholds | A/H3N2: >=80 (1/dilution) | 11 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) were defined as SAEs which included new onset of Guillain-Barré syndrome, encephalitis/myelitis (including transverse myelitis), Bell's palsy, convulsions, optic neuritis, and brachial neuritis.
Time frame: From Day 0 up to 6 months (i.e. 180 days) post last vaccination
Population: Analysis was performed on the SafAS population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | Fatal SAE | 0 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | SAE | 0 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | AESI | 0 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | Fatal SAE | 0 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | SAE | 0 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | AESI | 0 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | Fatal SAE | 0 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | SAE | 2 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | AESI | 1 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | Fatal SAE | 0 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | SAE | 0 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | AESI | 0 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | Fatal SAE | 0 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | SAE | 0 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | AESI | 0 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | SAE | 1 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | AESI | 0 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Serious Adverse Events (SAEs) After Any Vaccination | Fatal SAE | 0 Participants |
Primary
Number of Participants With Solicited Injection Site Reactions
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions included tenderness/pain, erythema, swelling, induration and bruising.
Time frame: Within 7 days after any vaccination
Population: Analysis was performed on the SafAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site induration | 21 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 31 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site tenderness/pain | 81 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site bruising | 10 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 17 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 30 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site induration | 18 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site tenderness/pain | 84 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site bruising | 10 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 15 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 40 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site induration | 26 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site bruising | 13 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 34 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site tenderness/pain | 100 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 23 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site tenderness/pain | 116 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 48 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site induration | 22 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Injection Site Reactions | Injection site bruising | 16 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Solicited Injection Site Reactions | Injection site induration | 4 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Solicited Injection Site Reactions | Injection site tenderness/pain | 6 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Solicited Injection Site Reactions | Injection site bruising | 1 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 5 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 2 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Solicited Injection Site Reactions | Injection site tenderness/pain | 5 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Solicited Injection Site Reactions | Injection site induration | 5 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 8 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Solicited Injection Site Reactions | Injection site bruising | 2 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 2 Participants |
Primary
Number of Participants With Solicited Systemic Reactions After Any Vaccination
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability. Fever was planned to be evaluated for the whole population where as, the other events (vomiting, crying abnormal, drowsiness, appetite lost, and irritability) were planned to be evaluated only in the participants aged 6 months to \<36 months.
Time frame: Within 7 days after any vaccination
Population: Analysis was performed on the SafAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever | 5 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Vomiting | 1 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Crying abnormal | 11 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Drowsiness | 14 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Appetite lost | 6 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Irritability | 14 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Vomiting | 2 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Drowsiness | 11 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Irritability | 13 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever | 6 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Crying abnormal | 9 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Appetite lost | 10 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Irritability | 18 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Appetite lost | 15 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Drowsiness | 12 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Crying abnormal | 10 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever | 15 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Vomiting | 7 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Drowsiness | 17 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Vomiting | 11 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Crying abnormal | 20 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Irritability | 23 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Appetite lost | 20 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever | 11 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever | 5 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Appetite lost | 11 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Vomiting | 5 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Crying abnormal | 6 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Drowsiness | 5 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Irritability | 6 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Drowsiness | 5 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Crying abnormal | 9 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Appetite lost | 11 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Irritability | 12 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Vomiting | 7 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever | 6 Participants |
Primary
Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited systemic reactions included: headache, malaise, myalgia and shivering.
Time frame: Within 7 days after any vaccination
Population: Analysis was performed on the SafAS population. Here, overall number of participants analyzed= participants evaluable for this outcome measure. Data not collected and reported for Groups 5 and 6 because none of the participants in both groups lies in the age group of \>36 months.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Headache | 18 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Malaise | 16 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Myalgia | 29 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Shivering | 1 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Malaise | 28 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Shivering | 8 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Headache | 18 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Myalgia | 30 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Headache | 22 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Shivering | 8 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Myalgia | 32 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Malaise | 27 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Shivering | 6 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Headache | 21 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Malaise | 32 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Solicited Systemic Reactions After Any Vaccination: Participants Aged >36 Months | Myalgia | 42 Participants |
Primary
Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer
Neutralizing Antibody titer was measured for each influenza strain with SN method for 4 strains: A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage. 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / pre-vaccination computed value.
Time frame: Day 28 post any vaccination
Population: Analysis was performed on the IAS population. Here, 'number analyzed' = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: A/H3N2 | 69 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: A/H1N1 | 65 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: A/H1N1 | 80 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: A/H3N2 | 44 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: B/Victoria | 95 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: B/Victoria | 80 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: B/Yamagata | 84 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: B/Yamagata | 71 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: A/H3N2 | 51 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: B/Yamagata | 81 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: A/H1N1 | 83 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: B/Yamagata | 95 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: B/Victoria | 88 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: A/H3N2 | 77 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: A/H1N1 | 70 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: B/Victoria | 99 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: A/H1N1 | 104 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: A/H3N2 | 110 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: A/H3N2 | 72 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: B/Yamagata | 109 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: B/Victoria | 131 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: B/Victoria | 113 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: B/Yamagata | 127 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: A/H1N1 | 118 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: B/Yamagata | 187 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: B/Victoria | 158 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: B/Victoria | 185 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: A/H1N1 | 168 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: A/H3N2 | 111 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: A/H3N2 | 61 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: B/Yamagata | 142 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: A/H1N1 | 141 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: B/Yamagata | 1 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: A/H1N1 | 6 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: B/Victoria | 2 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: B/Victoria | 0 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: B/Yamagata | 4 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: A/H1N1 | 5 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: A/H3N2 | 2 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: A/H3N2 | 0 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: B/Yamagata | 0 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: B/Victoria | 11 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: A/H3N2 | 7 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: A/H3N2 | 3 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: B/Victoria | 10 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 4-Fold Rise: A/H1N1 | 9 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: B/Yamagata | 3 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer | 2-Fold Rise: A/H1N1 | 10 Participants |
Primary
Number of Participants With Unsolicited Adverse Events After Any Vaccination
An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Adverse reactions (ARs) were AEs related to vaccination. An injection site reaction was an AR at and around the injection site. Systemic AEs were all AEs that were not injection or administration site reactions.
Time frame: Within 28 days after any vaccination
Population: Analysis was performed on the SafAS population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious systemic AE | 46 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious AR | 4 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited AE | 46 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious systemic AR | 4 Participants |
| Group 1: QIV-HD 30 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious injection site AR | 0 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious AR | 8 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious systemic AE | 45 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited AE | 46 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious systemic AR | 5 Participants |
| Group 2: QIV-HD 45 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious injection site AR | 3 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious AR | 8 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious systemic AE | 52 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious systemic AR | 8 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious injection site AR | 0 Participants |
| Group 3: QIV-HD, 60 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited AE | 53 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious injection site AR | 0 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited AE | 80 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious AR | 10 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious systemic AE | 80 Participants |
| Group 4: Pooled QIV-SD, 15 μg (US: 6 Months to 17 Years) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious systemic AR | 10 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious systemic AE | 11 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited AE | 11 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious systemic AR | 1 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious AR | 1 Participants |
| Group 5: QIV-HD, 60 μg (Canada: 6 to <24 Months) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious injection site AR | 0 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited AE | 12 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious systemic AE | 12 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious AR | 3 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious systemic AR | 2 Participants |
| Group 6: Adjuvanted TIV (Canada: 6 to <24 Months) | Number of Participants With Unsolicited Adverse Events After Any Vaccination | Unsolicited non-serious injection site AR | 1 Participants |