Prophylaxis of A/H3N2v Influenza
Conditions
Keywords
Influenza
Brief summary
Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in children ages 3 to \<9 years, adolescents 9 to \<18 years, adults 18 to \<65 years and elderly 65 years and older.
Interventions
Comparison of different dosages of vaccines
Sponsors
Study design
Eligibility
Inclusion criteria
1. Males and females 3 years of age and older 2. Individuals or, (for children and adolescents) parents or legal guardians, who have given written consent after the nature of the study has been explained according to local regulatory requirements. Assent is required depending on age of child/adolescent 3. Individuals in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator 4. Individuals who can comply with study procedures and are available for follow-up
Exclusion criteria
1. Individuals with behavioral or cognitive impairment, including psychiatric illness, as determined by the investigator's clinical judgement may interfere with the subject's ability to participate in study 2. Individuals with any progressive or severe neurologic disorder, seizure disorder or recent history of Guillian-Barré syndrome 3. Individuals or (for children and adolescents) parents or legal guardians who are not able to comprehend and to follow all required study procedures for the whole period of the study 4. Individuals with a history of illness/with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study 5. Individuals who have a suspected/confirmed diagnosis for any Adverse event of Special interest 6. Individuals with known or suspected impairment of the immune system including, but not limited to: * autoimmune disease such as rheumatoid arthritis, HIV infection, hypo- or agammaglobulinemia; * autoimmune disorders; * Systemic therapy with corticosteroids or other immunosuppressive therapy. * Receipt of immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the study 7. Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered 8. If female, of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry 9. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy 10. Acceptable birth control methods are defined as one or more of the following: 1. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring); 2. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse; 3. Intrauterine device (IUD); 4. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry. 11. If female of childbearing potential and sexually active, refusal to use an acceptable contraceptive method through to 3 weeks after last study vaccination 12. Individuals who are allergic to any of the vaccine components. 13. For children 17 years of age and younger: Individuals who have had ever a malignancy 14. For adults 18 years or older: Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years 15. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study 16. Individuals with a body temperature \>38°C (\>100.4°F) or any acute illness within 3 days of intended study vaccination 17. Individuals who have had a previous confirmed or suspected illness from swine flu (H3N2v) 18. Individuals who have received any prior H3N2v vaccine 19. Individuals who have received any other type of influenza vaccination (e.g., seasonal) within 14 days prior to enrolment, or who plans to receive influenza vaccine during the treatment phase of this study (seasonal influenza vaccination is allowed after Day 43/Visit 3) 20. Individuals who received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study or who are planning to receive any (non-influenza) vaccine within 4 weeks from the study vaccines 21. Individuals who are research staff involved with the clinical study or family/household members of research staff 22. Individuals with a BMI \> 35 kg/m2 (adults), \> 29 kg/m2 (adolescents), or \> 21 kg/m2 (children) 23. Individuals with a history of drug or alcohol abuse within the past 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1, Day 22, Day 43 post vaccination | The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported. |
| Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 through Day 7 after each vaccination | Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to \<9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination. |
| Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 through Day 7 after each vaccination | Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to \<18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination. |
| Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 through Day 7 after each vaccination | Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to \< 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination. |
| Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 through Day 7 after each vaccination | Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination. |
| Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 through Day 366 | The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported. The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported. |
| Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22, Day 43 post vaccination | The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported. Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer \<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1 | The geometric mean ratio (GMR) of post versus pre-vaccination HI antibody titers against H3N2 homologous strain following vaccination as compared to baseline titers are reported for after first (Day 22/Day 1) and second (Day 43/Day 1) vaccination and for persisting titers at six months (Day 183/Day1) and one year (Day 366/Day 1) is reported across subjects with age groups 3 to ≥ 65 years. |
| Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 and Day 366 post vaccination | The percentages of subjects (3 to ≥ 65 years of age) demonstrating HI titers ≥1:40 against H3N2 homologous strain on Day 183 and Day 366 post vaccination. |
| Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22, Day 43 post vaccination | The percentage of subjects achieving seroconversion or significant increase for HI antibody titers at three weeks after receiving first (Day 22) and second (Day 43) vaccination is reported, across age groups of 3 to ≥61 years. Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer \<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43. |
| Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1, Day 22, Day 43 post vaccination | The percentages of subjects achieving HI titers ≥1:40 against H3N2 homologous strain at three weeks after receiving first (day 22) and second (day 43) vaccination, is reported across age groups of 3 to ≥ 61 years. |
| GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1 | GMR of post-vaccination versus pre-vaccination HI GMTs following vaccination with H3N2 monovalent vaccine is reported across subjects with age groups 3 to ≥ 61 years. |
| Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination | The HI antibody titers against H3N2 homologous strain at baseline (Day 1), three weeks after first (Day 22) and second (Day 43) vaccination and persisting titers at six months (Day 183) and one year (Day 366) after vaccination are reported in terms of GMTs is reported across subjects with age groups 3 to ≥ 65 years. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled from 11 study centres in USA.
Pre-assignment details
All enrolled subjects were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| A/H3N2C + 1/2 MF59 : 3 TO <9 YEARS Subjects 3 to \<9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59. | 54 |
| A/H3N2C + MF59 : 3 TO <9 YEARS Subjects 3 to \<9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59. | 55 |
| A/H3N2C : 3 TO <9 YEARS Subjects 3 to \<9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen. | 51 |
| A/H3N2C + 1/2 MF59 : 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59. | 53 |
| A/H3N2C + MF59 : 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59. | 51 |
| A/H3N2C : 9 TO <18 YEARS Subjects 9 to \<18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen. | 53 |
| A/H3N2C + 1/2 MF59 : 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59. | 53 |
| A/H3N2C + MF59 : 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59. | 55 |
| A/H3N2C : 18 TO <65 YEARS Subjects 18 to \<65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen. | 48 |
| A/H3N2C + 1/2 MF59 : ≥65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59. | 51 |
| A/H3N2C + MF59 : ≥65 YEARS Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59. | 51 |
| A/H3N2C : ≥65 YEARS Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen. | 52 |
| Total | 627 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 11 | 10 | 7 | 3 | 0 | 3 | 4 | 7 | 2 | 0 | 0 | 2 |
| Overall Study | Other - Unclassified | 1 | 1 | 1 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 4 | 1 | 1 | 0 | 1 | 0 | 0 | 2 | 4 | 1 |
Baseline characteristics
| Characteristic | A/H3N2C + 1/2 MF59 : 3 TO <9 YEARS | A/H3N2C + MF59 : 3 TO <9 YEARS | A/H3N2C : 3 TO <9 YEARS | A/H3N2C + 1/2 MF59 : 9 TO <18 YEARS | A/H3N2C + MF59 : 9 TO <18 YEARS | A/H3N2C : 9 TO <18 YEARS | A/H3N2C + 1/2 MF59 : 18 TO <65 YEARS | A/H3N2C + MF59 : 18 TO <65 YEARS | A/H3N2C : 18 TO <65 YEARS | A/H3N2C + 1/2 MF59 : ≥65 YEARS | A/H3N2C + MF59 : ≥65 YEARS | A/H3N2C : ≥65 YEARS | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 6 YEARS STANDARD_DEVIATION 1.7 | 6 YEARS STANDARD_DEVIATION 1.6 | 6.2 YEARS STANDARD_DEVIATION 1.6 | 12.6 YEARS STANDARD_DEVIATION 2.7 | 12.8 YEARS STANDARD_DEVIATION 2.4 | 12.3 YEARS STANDARD_DEVIATION 2.4 | 42.3 YEARS STANDARD_DEVIATION 12.8 | 42.4 YEARS STANDARD_DEVIATION 13.3 | 44 YEARS STANDARD_DEVIATION 14.9 | 71.3 YEARS STANDARD_DEVIATION 5.3 | 72.9 YEARS STANDARD_DEVIATION 6.1 | 73.8 YEARS STANDARD_DEVIATION 6.1 | 33.2 YEARS STANDARD_DEVIATION 27.5 |
| Sex: Female, Male Female | 30 Participants | 27 Participants | 26 Participants | 29 Participants | 25 Participants | 26 Participants | 32 Participants | 25 Participants | 28 Participants | 31 Participants | 25 Participants | 32 Participants | 336 Participants |
| Sex: Female, Male Male | 24 Participants | 28 Participants | 25 Participants | 24 Participants | 26 Participants | 27 Participants | 21 Participants | 30 Participants | 20 Participants | 20 Participants | 26 Participants | 20 Participants | 291 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 36 / 50 | 46 / 54 | 30 / 50 | 44 / 54 | 42 / 51 | 45 / 53 | 35 / 51 | 43 / 54 | 30 / 48 | 33 / 52 | 31 / 49 | 32 / 51 |
| serious Total, serious adverse events | 0 / 50 | 1 / 54 | 0 / 50 | 0 / 54 | 0 / 51 | 1 / 53 | 3 / 51 | 0 / 54 | 1 / 48 | 2 / 52 | 5 / 49 | 5 / 51 |
Outcome results
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to \< 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Time frame: Day 1 through Day 7 after each vaccination
Population: Analysis was done on Solicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (2nd Vac.,N=46,48,48) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 1 | 23 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=50,52,45) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=46,51,48) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=50,53,47) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=46,50,48) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=50,53,46) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=46,51,48) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 1 | 23 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (1st Vac.,N=50,51,45) | 4 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 1 | 30 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (1st Vac.,N=51,54,47) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (2nd Vac.,N=47,50,47) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (2nd Vac.,N=44,50,47) | 4 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (1st Vac.,N=50,53,47) | 10 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (2nd Vac.,N=45,48,48) | 7 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (1st Vac.,N=51,53,47) | 11 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (2nd Vac.,N=47,49,48) | 9 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (1st Vac.,N=50,53,47) | 4 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (1st Vac.,N=49,53,47) | 12 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (1st Vac.,N=51,51,45) | 7 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (2nd Vac.,N=47,48,48) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (1st Vac.,N=50,52,47) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (1st Vac.,N=49,52,48) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (2nd Vac.,N=46,50,46) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (1st Vac.,N=49,53,48) | 5 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN /FEVER (2nd Vac.,N=46,50,46) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (1st Vac.,N=49,53,47) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (2nd Vac.,N=46,50,47) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 2 (N=47,51,48) | 21 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 2 | 17 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 2 | 15 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (1st Vac.,N=49,52,46) | 6 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (2nd Vac.,N=46,50,47) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (2nd Vac.,N=45,50,47) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (2nd Vac.,N=47,50,47) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (2nd Vac.,N=46,50,46) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (1st Vac.,N=49,53,47) | 12 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 1 | 32 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (2nd Vac.,N=45,50,47) | 10 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=50,52,45) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 2 (N=47,51,48) | 28 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (1st Vac.,N=49,53,48) | 4 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (2nd Vac.,N=47,49,48) | 9 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=50,53,47) | 5 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (1st Vac.,N=51,51,45) | 7 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (2nd Vac.,N=46,50,47) | 4 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=46,50,48) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (2nd Vac.,N=45,48,48) | 8 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN /FEVER (2nd Vac.,N=46,50,46) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=50,53,46) | 8 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 2 | 24 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (2nd Vac.,N=47,48,48) | 5 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=46,51,48) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (2nd Vac.,N=44,50,47) | 6 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (1st Vac.,N=50,53,47) | 4 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 1 | 27 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 2 | 20 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (1st Vac.,N=50,52,47) | 5 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (1st Vac.,N=49,53,47) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (1st Vac.,N=50,51,45) | 5 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (2nd Vac.,N=47,50,47) | 5 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (1st Vac.,N=50,53,47) | 11 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (2nd Vac.,N=46,48,48) | 4 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=46,51,48) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (1st Vac.,N=49,52,48) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (1st Vac.,N=51,54,47) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (1st Vac.,N=51,53,47) | 11 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (2nd Vac.,N=46,50,47) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (2nd Vac.,N=47,50,47) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (1st Vac.,N=49,52,46) | 10 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 1 | 40 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (1st Vac.,N=49,52,46) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (2nd Vac.,N=44,50,47) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (1st Vac.,N=50,53,47) | 8 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 1 | 27 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (2nd Vac.,N=45,48,48) | 7 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (1st Vac.,N=51,53,47) | 10 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (2nd Vac.,N=47,49,48) | 8 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 2 (N=47,51,48) | 21 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (1st Vac.,N=50,53,47) | 4 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (2nd Vac.,N=46,50,47) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 1 | 19 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (2nd Vac.,N=45,50,47) | 4 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (1st Vac.,N=50,52,47) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (1st Vac.,N=51,51,45) | 6 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (2nd Vac.,N=47,48,48) | 4 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 2 | 15 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (2nd Vac.,N=47,50,47) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (1st Vac.,N=49,52,48) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=46,51,48) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (2nd Vac.,N=46,50,46) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 1 | 19 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=50,52,45) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (1st Vac.,N=49,53,48) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=50,53,47) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=46,50,48) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=50,53,46) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN /FEVER (2nd Vac.,N=46,50,46) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=46,51,48) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (2nd Vac.,N=47,50,47) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 2 | 13 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (1st Vac.,N=50,51,45) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (1st Vac.,N=49,53,47) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (2nd Vac.,N=46,48,48) | 5 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (1st Vac.,N=49,53,47) | 4 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (1st Vac.,N=51,54,47) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (2nd Vac.,N=46,50,47) | 1 Number of Subjects |
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported. The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported.
Time frame: Day 1 through Day 366
Population: Analysis was done on unsolicited safety dataset i.e. all subjects in the exposed population who have post-vaccination unsolicited adverse event records.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any AE (Day 1 to Day 366) | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any SAE | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Death | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related AE | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AE leading to withdrawal | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NOCD | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AESI | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Medically attended AEs | 8 Number of subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NOCD | 0 Number of subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AESI | 0 Number of subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AE leading to withdrawal | 1 Number of subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Medically attended AEs | 21 Number of subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any SAE | 1 Number of subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any AE (Day 1 to Day 366) | 1 Number of subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Death | 0 Number of subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related | 0 Number of subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related AE | 0 Number of subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AESI | 0 Number of subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Death | 0 Number of subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related | 0 Number of subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NOCD | 1 Number of subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related AE | 0 Number of subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any SAE | 0 Number of subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AE leading to withdrawal | 0 Number of subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any AE (Day 1 to Day 366) | 0 Number of subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Medically attended AEs | 14 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any AE (Day 1 to Day 366) | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NOCD | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AESI | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any SAE | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related AE | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Death | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AE leading to withdrawal | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Medically attended AEs | 13 Number of subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AE leading to withdrawal | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Medically attended AEs | 13 Number of subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Death | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any AE (Day 1 to Day 366) | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related AE | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any SAE | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AESI | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NOCD | 2 Number of subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Death | 0 Number of subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AE leading to withdrawal | 0 Number of subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related | 0 Number of subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AESI | 0 Number of subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related AE | 0 Number of subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NOCD | 3 Number of subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any SAE | 1 Number of subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Medically attended AEs | 20 Number of subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any AE (Day 1 to Day 366) | 1 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AE leading to withdrawal | 3 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Death | 2 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Medically attended AEs | 21 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related AE | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AESI | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any SAE | 3 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NOCD | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any AE (Day 1 to Day 366) | 3 Number of subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any SAE | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AESI | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NOCD | 3 Number of subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Death | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related AE | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Medically attended AEs | 17 Number of subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any AE (Day 1 to Day 366) | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AE leading to withdrawal | 0 Number of subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AESI | 0 Number of subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NOCD | 1 Number of subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related AE | 0 Number of subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AE leading to withdrawal | 0 Number of subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any AE (Day 1 to Day 366) | 1 Number of subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related | 0 Number of subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Death | 0 Number of subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any SAE | 1 Number of subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Medically attended AEs | 13 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related AE | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Medically attended AEs | 31 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AESI | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any SAE | 2 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NOCD | 7 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Death | 0 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any AE (Day 1 to Day 366) | 2 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AE leading to withdrawal | 1 Number of subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Medically attended AEs | 22 Number of subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NOCD | 1 Number of subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AE leading to withdrawal | 3 Number of subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any AE (Day 1 to Day 366) | 5 Number of subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related AE | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any SAE | 5 Number of subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Death | 0 Number of subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AESI | 0 Number of subjects |
| A/H3N2C Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NOCD | 6 Number of subjects |
| A/H3N2C Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related AE | 0 Number of subjects |
| A/H3N2C Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AE leading to withdrawal | 1 Number of subjects |
| A/H3N2C Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any SAE | 5 Number of subjects |
| A/H3N2C Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | AESI | 0 Number of subjects |
| A/H3N2C Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | At least possibly related | 0 Number of subjects |
| A/H3N2C Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Medically attended AEs | 23 Number of subjects |
| A/H3N2C Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Any AE (Day 1 to Day 366) | 5 Number of subjects |
| A/H3N2C Age Group: >=65 YEARS | Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Death | 0 Number of subjects |
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to \<9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Time frame: Day 1 through Day 7 after each vaccination
Population: Analysis was done on Solicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (1st Vac.,N=32,28,32) | 4 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 2 | 16 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (2nd Vac.,N=44,51,46) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (2nd Vac.,N=32,30,30) | 4 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (1st Vac.,N=32,27,32) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (2nd Vac.,N=33,29,31) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,31) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | IRRITABILITY (2nd Vac.,N=11,20,16) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (1st Vac.,N=49,53,49) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 1 | 28 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | IRRITABILITY (1st Vac.,N=13,19,16) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (2nd Vac.,N=42,52,48) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (1st Vac.,N=46,47,48) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (2nd Vac.,N=33,31,32) | 4 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | CHANGE IN EATING HABITS (1st Vac.,N=13,19,15) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=32,31,32) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (1st Vac.,N=32,28,31) | 6 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 2 (N= 45,52,48) | 24 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (2nd Vac.,N=33,30,32) | 5 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (1st Vac.,N=45,46,46) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (2nd Vac.,N=44,51,47) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (1st Vac.,N=31,28,31) | 5 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (2nd Vac.,N=43,50,46) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), < 6y (T.II, 1st Vac.,N=14,20,16) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | CHANGE IN EATING HABITS (2nd Vac.,N=12,20,16) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (1st Vac.,N=46,49,46) | 4 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,31) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 2 | 22 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | SLEEPINESS (1st Vac.,N=13,19,16) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), < 6y (T.II, 2nd Vac.,N=12,21,16) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (1st Vac.,N=31,27,30) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (2nd Vac.,N=44,51,47) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=31,31,31) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), < 6y (T.II, 1st Vac.,N=14,20,15) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (1st Vac.,N=46,48,46) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), < 6y (T.II, 1st Vac.,N=14,20,16) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 1 | 31 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (2nd Vac.,N=31,31,30) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), < 6y (T.II, 2nd Vac.,N=12,21,16) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | SLEEPINESS (2nd Vac.,N=12,20,16) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (1st Vac.,N=32,28,31) | 5 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,32) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (2nd Vac.,N=33,31,32) | 4 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=32,31,31) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), < 6y (T.II, 2nd Vac.,N=11,21,16) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (2nd Vac.,N=32,30,30) | 6 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 1 | 15 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (1st Vac.,N=32,28,32) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), < 6y (T.II, 1st Vac.,N=14,20,16) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 1 | 36 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 2 (N= 45,52,48) | 25 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 1 | 33 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), < 6y (T.II, 1st Vac.,N=14,20,15) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), < 6y (T.II, 2nd Vac.,N=11,21,16) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,31) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=32,31,32) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), < 6y (T.II, 1st Vac.,N=14,20,16) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,31) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), < 6y (T.II, 2nd Vac.,N=12,21,16) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=31,31,31) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), < 6y (T.II, 2nd Vac.,N=12,21,16) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,32) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=32,31,31) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 1 | 19 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 2 | 11 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (2nd Vac.,N=33,29,31) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (1st Vac.,N=49,53,49) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (2nd Vac.,N=42,52,48) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | CHANGE IN EATING HABITS (1st Vac.,N=13,19,15) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | CHANGE IN EATING HABITS (2nd Vac.,N=12,20,16) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (1st Vac.,N=45,46,46) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (2nd Vac.,N=43,50,46) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (1st Vac.,N=31,28,31) | 9 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (2nd Vac.,N=33,30,32) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (1st Vac.,N=32,28,31) | 5 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (2nd Vac.,N=33,31,32) | 4 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | IRRITABILITY (1st Vac.,N=13,19,16) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | IRRITABILITY (2nd Vac.,N=11,20,16) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (1st Vac.,N=32,27,32) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (2nd Vac.,N=32,30,30) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (1st Vac.,N=32,28,32) | 7 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (2nd Vac.,N=32,30,30) | 4 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (2nd Vac.,N=33,31,32) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (1st Vac.,N=32,28,31) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (2nd Vac.,N=31,31,30) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (1st Vac.,N=46,48,46) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (2nd Vac.,N=44,51,47) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | SLEEPINESS (1st Vac.,N=13,19,16) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | SLEEPINESS (2nd Vac.,N=12,20,16) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (1st Vac.,N=46,49,46) | 6 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (2nd Vac.,N=44,51,47) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (1st Vac.,N=46,47,48) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (2nd Vac.,N=44,51,46) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 2 | 24 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (1st Vac.,N=31,27,30) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (1st Vac.,N=32,28,32) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (2nd Vac.,N=32,30,30) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 1 | 7 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (2nd Vac.,N=44,51,47) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (1st Vac.,N=32,28,32) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=32,31,31) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,31) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (2nd Vac.,N=32,30,30) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (1st Vac.,N=32,28,32) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,32) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 1 | 16 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (2nd Vac.,N=33,31,32) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), < 6y (T.II, 2nd Vac.,N=12,21,16) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (1st Vac.,N=46,47,48) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (1st Vac.,N=32,28,31) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), < 6y (T.II, 1st Vac.,N=14,20,16) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), < 6y (T.II, 2nd Vac.,N=11,21,16) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (2nd Vac.,N=31,31,30) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=31,31,31) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 2 (N= 45,52,48) | 22 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (1st Vac.,N=46,48,46) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), < 6y (T.II, 2nd Vac.,N=12,21,16) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (2nd Vac.,N=44,51,46) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (2nd Vac.,N=44,51,47) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,31) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (2nd Vac.,N=43,50,46) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (1st Vac.,N=45,46,46) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 1 | 18 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (1st Vac.,N=31,28,31) | 4 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | CHANGE IN EATING HABITS (2nd Vac.,N=12,20,16) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), < 6y (T.II, 1st Vac.,N=14,20,15) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (2nd Vac.,N=33,30,32) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | CHANGE IN EATING HABITS (1st Vac.,N=13,19,15) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | SLEEPINESS (2nd Vac.,N=12,20,16) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (1st Vac.,N=32,28,31) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (2nd Vac.,N=42,52,48) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), < 6y (T.II, 1st Vac.,N=14,20,16) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (2nd Vac.,N=33,31,32) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (1st Vac.,N=49,53,49) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 2 | 17 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | IRRITABILITY (1st Vac.,N=13,19,16) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (2nd Vac.,N=33,29,31) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (1st Vac.,N=46,49,46) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | IRRITABILITY (2nd Vac.,N=11,20,16) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (1st Vac.,N=31,27,30) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=32,31,32) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (1st Vac.,N=32,27,32) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 2 | 12 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | SLEEPINESS (1st Vac.,N=13,19,16) | 1 Number of Subjects |
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Time frame: Day 1 through Day 7 after each vaccination
Population: Analysis was done on Solicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (1st Vac.,N=48,46,50) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (2nd Vac.,N=51,44,48) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=51,45,49) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (2nd Vac.,N=50,45,47) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (2nd Vac.,N=49,44,44) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 1 | 23 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (1st Vac.,N=51,49,50) | 5 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (1st Vac.,N=49,48,49) | 8 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (1st Vac.,N=50,47,48) | 5 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (1st Vac.,N=49,48,50) | 4 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (2nd Vac.,N=51,44,48) | 5 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=49,44,48) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (2nd Vac.,N=50,45,46) | 4 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (1st Vac.,N=50,49,50) | 8 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (2nd Vac.,N=50,43,48) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (1st Vac.,N=50,48,49) | 5 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (1st Vac.,N=50,48,49) | 6 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 1 | 17 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (2nd Vac.,N=50,45,46) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=51,48,50) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vac. 2 | 9 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (2nd Vac.,N=49,45,46) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=49,44,48) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=51,49,50) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (2nd Vac.,N=50,44,48) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 2 | 8 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (1st Vac.,N=51,48,49) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 2 (N=51,45,48) | 14 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (1st Vac.,N=47,45,50) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (2nd Vac.,N=51,44,48) | 5 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (1st Vac.,N=48,46,50) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (2nd Vac.,N=50,43,47) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=49,45,48) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (2nd Vac.,N=50,44,48) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (1st Vac.,N=51,48,50) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vac. 1 | 11 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (1st Vac.,N=48,46,50) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 1 | 29 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vac. 1 | 21 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=51,49,50) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=49,45,48) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=51,45,49) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=49,44,48) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=51,48,50) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 1 | 16 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 2 | 11 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (1st Vac.,N=47,45,50) | 4 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (2nd Vac.,N=50,43,47) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (1st Vac.,N=51,48,50) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (2nd Vac.,N=51,44,48) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (2nd Vac.,N=49,44,44) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (1st Vac.,N=49,48,49) | 8 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (2nd Vac.,N=51,44,48) | 6 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (1st Vac.,N=50,49,50) | 6 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (1st Vac.,N=50,48,49) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (2nd Vac.,N=50,45,46) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (1st Vac.,N=50,48,49) | 6 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (2nd Vac.,N=50,45,46) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (1st Vac.,N=49,48,50) | 5 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (1st Vac.,N=51,49,50) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (2nd Vac.,N=50,45,47) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (1st Vac.,N=48,46,50) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (2nd Vac.,N=50,44,48) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (2nd Vac.,N=50,44,48) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (1st Vac.,N=51,48,49) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (2nd Vac.,N=49,45,46) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 2 (N=51,45,48) | 17 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vac. 2 | 14 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=49,44,48) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (1st Vac.,N=50,47,48) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (2nd Vac.,N=51,44,48) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (2nd Vac.,N=50,43,48) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=49,44,48) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (2nd Vac.,N=50,45,47) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (1st Vac.,N=51,48,50) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=49,44,48) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (1st Vac.,N=48,46,50) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (2nd Vac.,N=50,43,47) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (2nd Vac.,N=51,44,48) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (2nd Vac.,N=50,44,48) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (1st Vac.,N=47,45,50) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 2 | 11 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (1st Vac.,N=48,46,50) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 1 | 13 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=51,45,49) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 1 | 15 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (1st Vac.,N=51,48,49) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=51,48,50) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (1st Vac.,N=50,49,50) | 4 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (2nd Vac.,N=49,45,46) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=51,49,50) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (1st Vac.,N=50,48,49) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 2 (N=51,45,48) | 14 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (2nd Vac.,N=50,45,46) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (2nd Vac.,N=51,44,48) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (2nd Vac.,N=50,44,48) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (1st Vac.,N=50,48,49) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (2nd Vac.,N=51,44,48) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vac. 2 | 5 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (2nd Vac.,N=50,45,46) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (1st Vac.,N=49,48,49) | 4 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=49,45,48) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (1st Vac.,N=49,48,50) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (2nd Vac.,N=50,43,48) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (2nd Vac.,N=49,44,44) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vac. 1 | 6 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (1st Vac.,N=51,49,50) | 3 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (1st Vac.,N=50,47,48) | 4 Number of Subjects |
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to \<18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Time frame: Day 1 through Day 7 after each vaccination
Population: Analysis was done on Solicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II) (1st Vac.,N=52,51,53) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (2nd Vac.,N=51,48,53) | 9 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II) (2nd Vac.,N=51,48,52) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II) (1st Vac.,N=52,51,53) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (1st Vac.,N=53,50,53) | 13 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II) (2nd Vac.,N=52,48,52) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 1 | 35 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=53,51,53) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (1st Vac.,N=53,51,51) | 6 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (1st Vac.,N=53,51,51) | 10 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (2nd Vac.,N=50,48,49) | 1 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (2nd Vac.,N=51,48,49) | 5 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 1 | 25 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 2 (N=52,48,53) | 30 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (1st Vac.,N=53,51,51) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (1st Vac.,N=52,51,53) | 6 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (2nd Vac.,N=50,48,53) | 11 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (2nd Vac.,N=49,47,53) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (2nd Vac.,N=50,48,53) | 5 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 2 | 17 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (1st Vac.,N=54,49,52) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (1st Vac.,N=53,51,53) | 9 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (2nd Vac.,N=50,48,53) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (1st Vac.,N=53,51,53) | 12 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (1st Vac.,N=51,50,51) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 2 | 24 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (1st Vac.,N=51,51,51) | 3 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE >=38C (1st Vac.,N=53,51,53) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (1st Vac.,N=54,50,52) | 5 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (2nd Vac.,N=49,48,52) | 4 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (2nd Vac.,N=51,48,52) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (2nd Vac.,N=51,48,49) | 7 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 1 | 37 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (2nd Vac.,N=50,47,49) | 2 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II) (2nd Vac.,N=52,48,52) | 0 Number of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (2nd Vac.,N=50,47,53) | 0 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II) (1st Vac.,N=52,51,53) | 7 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 1 | 40 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 2 (N=52,48,53) | 24 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 1 | 34 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=53,51,53) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II) (2nd Vac.,N=52,48,52) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II) (2nd Vac.,N=52,48,52) | 4 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 1 | 32 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 2 | 14 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (1st Vac.,N=51,50,51) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE >=38C (1st Vac.,N=53,51,53) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (1st Vac.,N=51,51,51) | 5 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (2nd Vac.,N=50,47,49) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (1st Vac.,N=53,51,53) | 16 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (2nd Vac.,N=51,48,53) | 12 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (1st Vac.,N=53,50,53) | 16 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (2nd Vac.,N=50,48,53) | 9 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (1st Vac.,N=53,51,51) | 9 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (2nd Vac.,N=51,48,49) | 4 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (2nd Vac.,N=51,48,49) | 5 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (1st Vac.,N=52,51,53) | 9 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (2nd Vac.,N=50,48,53) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (2nd Vac.,N=50,48,53) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (1st Vac.,N=54,49,52) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (2nd Vac.,N=49,47,53) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (1st Vac.,N=53,51,51) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 2 | 20 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II) (1st Vac.,N=52,51,53) | 3 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II) (2nd Vac.,N=51,48,52) | 2 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (2nd Vac.,N=49,48,52) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (2nd Vac.,N=51,48,52) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (1st Vac.,N=53,51,51) | 12 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (1st Vac.,N=53,51,53) | 10 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (2nd Vac.,N=50,47,53) | 1 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (1st Vac.,N=54,50,52) | 4 Number of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (2nd Vac.,N=50,48,49) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 2 | 23 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (2nd Vac.,N=50,48,53) | 9 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II) (2nd Vac.,N=52,48,52) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (2nd Vac.,N=51,48,53) | 9 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (1st Vac.,N=53,51,53) | 5 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II) (1st Vac.,N=52,51,53) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INJECTION SITE REACTIONS- Vacc. 1 | 27 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ERYTHEMA (mm), ≥ 6y (T.II) (2nd Vac.,N=51,48,52) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | FATIGUE (1st Vac.,N=53,51,53) | 18 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (1st Vac.,N=51,51,51) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II) (1st Vac.,N=52,51,53) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (1st Vac.,N=51,50,51) | 7 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE >=38C (1st Vac.,N=53,51,53) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 2 (N=52,48,53) | 27 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (2nd Vac.,N=50,48,49) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | BODY TEMPERATURE ≥38°C (2nd Vac.,N=51,48,52) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ARTHRALGIA (2nd Vac.,N=49,48,52) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | DIARRHEA (2nd Vac.,N=50,47,49) | 4 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 2 | 15 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | HEADACHE (1st Vac.,N=53,50,53) | 11 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | SYSTEMIC REACTIONS- Vacc. 1 | 26 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (2nd Vac.,N=51,48,49) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | INDURATION (mm), ≥ 6y (T.II) (2nd Vac.,N=52,48,52) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | NAUSEA (2nd Vac.,N=50,48,53) | 6 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (2nd Vac.,N=50,48,53) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (2nd Vac.,N=50,47,53) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | PREV.OF PAIN/FEVER (1st Vac.,N=54,49,52) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (1st Vac.,N=54,50,52) | 2 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MYALGIA (1st Vac.,N=52,51,53) | 5 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (1st Vac.,N=53,51,51) | 10 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | TREAT.OF PAIN/FEVER (2nd Vac.,N=49,47,53) | 1 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | MALAISE (2nd Vac.,N=51,48,49) | 4 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=53,51,53) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | VOMITING (1st Vac.,N=53,51,51) | 0 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | LOSS OF APPETITE (1st Vac.,N=53,51,51) | 6 Number of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | ANY- Vac. 1 | 35 Number of Subjects |
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.
Time frame: Day 1, Day 22, Day 43 post vaccination
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 100 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 8 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 96 Percentages of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 100 Percentages of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 98 Percentages of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 7 Percentages of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 96 Percentages of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 78 Percentages of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 14 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 100 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 45 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 100 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 59 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 100 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 100 Percentages of Subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 100 Percentages of Subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 49 Percentages of Subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 98 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 96 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 57 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 96 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 100 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 100 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 67 Percentages of Subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 88 Percentages of Subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 67 Percentages of Subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 98 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 98 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 56 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 94 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 52 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 100 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 100 Percentages of Subjects |
| A/H3N2C Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 96 Percentages of Subjects |
| A/H3N2C Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 46 Percentages of Subjects |
| A/H3N2C Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 96 Percentages of Subjects |
Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported. Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer \<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43.
Time frame: Day 22, Day 43 post vaccination
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 96 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50) | 100 Percentages of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50) | 100 Percentages of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 98 Percentages of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 71 Percentages of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50) | 92 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 88 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50) | 94 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 98 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50) | 98 Percentages of Subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 85 Percentages of Subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50) | 91 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 73 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50) | 82 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50) | 92 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 89 Percentages of Subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50) | 71 Percentages of Subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 67 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50) | 58 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 57 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50) | 80 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 71 Percentages of Subjects |
| A/H3N2C Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 61 Percentages of Subjects |
| A/H3N2C Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50) | 64 Percentages of Subjects |
Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).
The HI antibody titers against H3N2 homologous strain at baseline (Day 1), three weeks after first (Day 22) and second (Day 43) vaccination and persisting titers at six months (Day 183) and one year (Day 366) after vaccination are reported in terms of GMTs is reported across subjects with age groups 3 to ≥ 65 years.
Time frame: Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1 | 8.48 Titers |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 192 Titers |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 524 Titers |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 46 Titers |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 97 Titers |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 145 Titers |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1 | 8.26 Titers |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 70 Titers |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 679 Titers |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 277 Titers |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 37 Titers |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1 | 8.8 Titers |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 67 Titers |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 93 Titers |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 198 Titers |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 486 Titers |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 173 Titers |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 112 Titers |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 386 Titers |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1 | 28 Titers |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 124 Titers |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 656 Titers |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 456 Titers |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1 | 29 Titers |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 242 Titers |
| A/H3N2C Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 389 Titers |
| A/H3N2C Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 170 Titers |
| A/H3N2C Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1 | 27 Titers |
| A/H3N2C Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 111 Titers |
| A/H3N2C Age Group: 9 TO <18 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 343 Titers |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 276 Titers |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 161 Titers |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 111 Titers |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1 | 34 Titers |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 300 Titers |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 170 Titers |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1 | 52 Titers |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 427 Titers |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 504 Titers |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 219 Titers |
| A/H3N2C Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 261 Titers |
| A/H3N2C Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 126 Titers |
| A/H3N2C Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 188 Titers |
| A/H3N2C Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1 | 42 Titers |
| A/H3N2C Age Group: 18 TO <65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 226 Titers |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1 | 36 Titers |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 131 Titers |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 55 Titers |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 135 Titers |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 93 Titers |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 206 Titers |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 122 Titers |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1 | 32 Titers |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 202 Titers |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 71 Titers |
| A/H3N2C Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51) | 140 Titers |
| A/H3N2C Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 98 Titers |
| A/H3N2C Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 1 | 26 Titers |
| A/H3N2C Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 68 Titers |
| A/H3N2C Age Group: >=65 YEARS | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age). | Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 163 Titers |
Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
The geometric mean ratio (GMR) of post versus pre-vaccination HI antibody titers against H3N2 homologous strain following vaccination as compared to baseline titers are reported for after first (Day 22/Day 1) and second (Day 43/Day 1) vaccination and for persisting titers at six months (Day 183/Day1) and one year (Day 366/Day 1) is reported across subjects with age groups 3 to ≥ 65 years.
Time frame: Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 59 Ratios |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49) | 10 Ratios |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49) | 4.83 Ratios |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1 | 22 Ratios |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1 | 33 Ratios |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 82 Ratios |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49) | 8.23 Ratios |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49) | 17 Ratios |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1 | 11 Ratios |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 23 Ratios |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49) | 4.13 Ratios |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49) | 7.17 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1 | 14 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49) | 4.28 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49) | 6.59 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 18 Ratios |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1 | 15 Ratios |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 21 Ratios |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49) | 8.2 Ratios |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49) | 4.21 Ratios |
| A/H3N2C Age Group: 9 TO <18 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 14 Ratios |
| A/H3N2C Age Group: 9 TO <18 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49) | 4.15 Ratios |
| A/H3N2C Age Group: 9 TO <18 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1 | 13 Ratios |
| A/H3N2C Age Group: 9 TO <18 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49) | 6.38 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 7.16 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1 | 7.54 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49) | 3.95 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49) | 2.79 Ratios |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49) | 3.97 Ratios |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 9.58 Ratios |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49) | 4.95 Ratios |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1 | 11 Ratios |
| A/H3N2C Age Group: 18 TO <65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49) | 4.4 Ratios |
| A/H3N2C Age Group: 18 TO <65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 6.24 Ratios |
| A/H3N2C Age Group: 18 TO <65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1 | 5.35 Ratios |
| A/H3N2C Age Group: 18 TO <65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49) | 2.99 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1 | 3.79 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49) | 2.6 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49) | 1.6 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 3.82 Ratios |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49) | 3.83 Ratios |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49) | 2.33 Ratios |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 6.55 Ratios |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1 | 6.64 Ratios |
| A/H3N2C Age Group: >=65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50) | 5.94 Ratios |
| A/H3N2C Age Group: >=65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49) | 2.33 Ratios |
| A/H3N2C Age Group: >=65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1 | 5.13 Ratios |
| A/H3N2C Age Group: >=65 YEARS | Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49) | 3.4 Ratios |
GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
GMR of post-vaccination versus pre-vaccination HI GMTs following vaccination with H3N2 monovalent vaccine is reported across subjects with age groups 3 to ≥ 61 years.
Time frame: Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60) | 22 Ratios |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59) | 59 Ratios |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58 | 9.96 Ratios |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58 | 4.55 Ratios |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60) | 33 Ratios |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58 | 17 Ratios |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59) | 82 Ratios |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58 | 8.26 Ratios |
| A/H3N2C - Age Group: 3 TO <9 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58 | 4.09 Ratios |
| A/H3N2C - Age Group: 3 TO <9 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60) | 11 Ratios |
| A/H3N2C - Age Group: 3 TO <9 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58 | 7.18 Ratios |
| A/H3N2C - Age Group: 3 TO <9 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59) | 23 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58 | 4.43 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58 | 6.76 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59) | 18 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60) | 14 Ratios |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58 | 8.19 Ratios |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60) | 15 Ratios |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58 | 4.20 Ratios |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59) | 21 Ratios |
| A/H3N2C Age Group: 9 TO <18 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58 | 6.38 Ratios |
| A/H3N2C Age Group: 9 TO <18 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60) | 13 Ratios |
| A/H3N2C Age Group: 9 TO <18 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59) | 14 Ratios |
| A/H3N2C Age Group: 9 TO <18 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58 | 4.15 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59) | 7.1 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58 | 2.73 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60) | 7.8 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58 | 3.98 Ratios |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58 | 5.23 Ratios |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60) | 12 Ratios |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59) | 10 Ratios |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58 | 4.21 Ratios |
| A/H3N2C Age Group: 18 TO <65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58 | 4.30 Ratios |
| A/H3N2C Age Group: 18 TO <65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58 | 3.03 Ratios |
| A/H3N2C Age Group: 18 TO <65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59) | 6.04 Ratios |
| A/H3N2C Age Group: 18 TO <65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60) | 4.93 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58 | 1.69 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60) | 4.05 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58 | 2.69 Ratios |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59) | 4.14 Ratios |
| A/H3N2C + MF59 Age Group: >=65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58 | 3.82 Ratios |
| A/H3N2C + MF59 Age Group: >=65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59) | 6.57 Ratios |
| A/H3N2C + MF59 Age Group: >=65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58 | 2.35 Ratios |
| A/H3N2C + MF59 Age Group: >=65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60) | 6.73 Ratios |
| A/H3N2C Age Group: >=65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58 | 2.37 Ratios |
| A/H3N2C Age Group: >=65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58 | 3.56 Ratios |
| A/H3N2C Age Group: >=65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60) | 5.53 Ratios |
| A/H3N2C Age Group: >=65 YEARS | GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59) | 6.2 Ratios |
Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
The percentages of subjects achieving HI titers ≥1:40 against H3N2 homologous strain at three weeks after receiving first (day 22) and second (day 43) vaccination, is reported across age groups of 3 to ≥ 61 years.
Time frame: Day 1, Day 22, Day 43 post vaccination
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 8 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 100 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60) | 96 Percentages of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60) | 98 Percentages of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 100 Percentages of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 7 Percentages of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 14 Percentages of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60) | 78 Percentages of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 96 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 100 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60) | 100 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 44 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 100 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60) | 100 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 59 Percentages of Subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 49 Percentages of Subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60) | 98 Percentages of Subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 100 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 60 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 98 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60) | 98 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 67 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 100 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60) | 100 Percentages of Subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60) | 90 Percentages of Subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 74 Percentages of Subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 100 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60) | 93 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 53 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 96 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60) | 100 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 54 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 100 Percentages of Subjects |
| A/H3N2C Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60) | 93 Percentages of Subjects |
| A/H3N2C Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 95 Percentages of Subjects |
| A/H3N2C Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 1 | 44 Percentages of Subjects |
Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
The percentage of subjects achieving seroconversion or significant increase for HI antibody titers at three weeks after receiving first (Day 22) and second (Day 43) vaccination is reported, across age groups of 3 to ≥61 years. Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer \<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43.
Time frame: Day 22, Day 43 post vaccination
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 | 96 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 100 Percentages of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 | 98 Percentages of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 100 Percentages of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 | 71 Percentages of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 92 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 | 89 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 94 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 98 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 | 98 Percentages of Subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 | 85 Percentages of Subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 91 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 85 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 | 74 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 | 90 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 93 Percentages of Subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 67 Percentages of Subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 | 64 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 | 57 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 58 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 80 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 | 73 Percentages of Subjects |
| A/H3N2C Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59) | 68 Percentages of Subjects |
| A/H3N2C Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | Day 22 | 63 Percentages of Subjects |
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
The percentages of subjects (3 to ≥ 65 years of age) demonstrating HI titers ≥1:40 against H3N2 homologous strain on Day 183 and Day 366 post vaccination.
Time frame: Day 183 and Day 366 post vaccination
Population: Analysis was done on the full analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 82 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 95 Percentages of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 98 Percentages of Subjects |
| A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 91 Percentages of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 58 Percentages of Subjects |
| A/H3N2C - Age Group: 3 TO <9 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 81 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 98 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 94 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 100 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 98 Percentages of Subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 100 Percentages of Subjects |
| A/H3N2C Age Group: 9 TO <18 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 89 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 87 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 81 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 100 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 96 Percentages of Subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 80 Percentages of Subjects |
| A/H3N2C Age Group: 18 TO <65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 87 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 75 Percentages of Subjects |
| A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 91 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 94 Percentages of Subjects |
| A/H3N2C + MF59 Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 80 Percentages of Subjects |
| A/H3N2C Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49) | 80 Percentages of Subjects |
| A/H3N2C Age Group: >=65 YEARS | Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine. | Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49) | 88 Percentages of Subjects |