Influenza
Conditions
Keywords
Influenza, Flu, Cell-Derived, Egg-Derived, Healthy Adults, Safety, Immunogenicity, Vaccination
Brief summary
The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.
Interventions
BIOLOGICALCell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1
BIOLOGICALCell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV)
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
BIOLOGICALCell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3
One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18 to \<61 years of age 2. mentally competent to understand the nature, the scope and the consequences of the study 3. able and willing to give written informed consent prior to study entry 4. in good health as determined by: 1. medical history, 2. physical examination, 3. clinical judgment of the Investigator.
Exclusion criteria
1. unwilling or unable to give written informed consent to participate in the study 2. participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study 3. currently experiencing an acute infectious disease 4. any serious disease, such as, for example: 1. cancer, 2. autoimmune disease (including rheumatoid arthritis), 3. advanced arteriosclerotic disease or complicated diabetes mellitus, 4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy, 5. acute or progressive hepatic disease, 6. acute or progressive renal disease, 7. congestive heart failure 5. surgery planned during the study period 6. bleeding diathesis 7. history of hypersensitivity to any component of the study medication or chemically related substances 8. history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component 9. known or suspected impairment/alteration of immune function, for example resulting from: 1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy), 2. receipt of immunostimulants, 3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study, 4. high risk for developing an immunocompromising disease 10. history of drug or alcohol abuse 11. laboratory-confirmed influenza disease within 6 months prior to Visit 1 12. receipt of influenza vaccine within 6 months prior to Visit 1 13. receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination 14. any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1 15. if female, pregnant or breastfeeding 16. if female, refusal to use a reliable contraceptive method during the three weeks following vaccination 17. planned relocation abroad during the study period 18. any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | Day 22 postvaccination | The haemagglutinin Inhibition (HI) antibody titer response following 1. one dose of cTIV for each of the three lots separately and 2. one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs). The HI GMTs were evaluated using egg-derived antigen assay. |
| Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | Day 22 postvaccination | Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is \>2.5. |
| Percentage of Subjects With HI Titers ≥40 | Day 22 postvaccination | Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is \>70%. |
| Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | Day 22 postvaccination | Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after 1. one dose of cTIV for each of the three vaccine lots separately and 2. one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is \>40%. As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer \<10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Day 1 to Day 7 postvaccination | To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV. |
| Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Day 1 - Day 181 postvaccination | Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported. |
Countries
Lithuania
Participant flow
Recruitment details
1200 subjects were enrolled from 2 sites in Lithuania. Of the 1200 subjects enrolled, 700 (58%) were randomized in site 1 and 500 (42%) in site 2. Baseline characteristics, outcome measures, and adverse event summary are based on retrospective analysis which excluded data from site 2.
Pre-assignment details
All participants enrolled were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| cTIV (Combined) Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3). | 600 |
| TIV Group Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV). | 100 |
| Total | 700 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | cTIV (Combined) | TIV Group | Total |
|---|---|---|---|
| Age, Continuous | 27.3 years STANDARD_DEVIATION 11.1 | 26.9 years STANDARD_DEVIATION 11.5 | 27.2 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment Lithuania | 600 participants | 100 participants | 700 participants |
| Sex: Female, Male Female | 321 Participants | 58 Participants | 379 Participants |
| Sex: Female, Male Male | 279 Participants | 42 Participants | 321 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 237 / 599 | 35 / 100 |
| serious Total, serious adverse events | 16 / 599 | 2 / 100 |
Outcome results
Primary
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is \>2.5.
Time frame: Day 22 postvaccination
Population: The analysis was performed as PP dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| cTIV_lot1 | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (Day22/Day1) | 20 Ratio |
| cTIV_lot1 | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (Day22/Day1) | 14 Ratio |
| cTIV_lot1 | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (Day22/Day1) | 10 Ratio |
| cTIV_lot 2 | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (Day22/Day1) | 9.42 Ratio |
| cTIV_lot 2 | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (Day22/Day1) | 18 Ratio |
| cTIV_lot 2 | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (Day22/Day1) | 11 Ratio |
| cTIV_lot3 | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (Day22/Day1) | 9.37 Ratio |
| cTIV_lot3 | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (Day22/Day1) | 18 Ratio |
| cTIV_lot3 | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (Day22/Day1) | 9.92 Ratio |
| cTIV (Combined) | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (Day22/Day1) | 18 Ratio |
| cTIV (Combined) | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (Day22/Day1) | 12 Ratio |
| cTIV (Combined) | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (Day22/Day1) | 9.63 Ratio |
| TIV Group | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (Day22/Day1) | 15 Ratio |
| TIV Group | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (Day22/Day1) | 7.53 Ratio |
| TIV Group | Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (Day22/Day1) | 12 Ratio |
Primary
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
The haemagglutinin Inhibition (HI) antibody titer response following 1. one dose of cTIV for each of the three lots separately and 2. one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs). The HI GMTs were evaluated using egg-derived antigen assay.
Time frame: Day 22 postvaccination
Population: This analysis was done on per protocol (PP) population defined as all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| cTIV_lot1 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (day 1) | 13 Titers |
| cTIV_lot1 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (day 22) | 390 Titers |
| cTIV_lot1 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (day 22) | 175 Titers |
| cTIV_lot1 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (day 22) | 131 Titers |
| cTIV_lot1 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (day 1) | 20 Titers |
| cTIV_lot1 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (day 1) | 12 Titers |
| cTIV_lot 2 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (day 1) | 15 Titers |
| cTIV_lot 2 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (day 1) | 20 Titers |
| cTIV_lot 2 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (day 1) | 17 Titers |
| cTIV_lot 2 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (day 22) | 171 Titers |
| cTIV_lot 2 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (day 22) | 157 Titers |
| cTIV_lot 2 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (day 22) | 364 Titers |
| cTIV_lot3 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (day 22) | 158 Titers |
| cTIV_lot3 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (day 1) | 16 Titers |
| cTIV_lot3 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (day 1) | 21 Titers |
| cTIV_lot3 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (day 22) | 366 Titers |
| cTIV_lot3 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (day 1) | 14 Titers |
| cTIV_lot3 | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (day 22) | 128 Titers |
| cTIV (Combined) | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (day 22) | 168 Titers |
| cTIV (Combined) | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (day 1) | 20 Titers |
| cTIV (Combined) | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (day 1) | 14 Titers |
| cTIV (Combined) | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (day 22) | 373 Titers |
| cTIV (Combined) | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (day 22) | 138 Titers |
| cTIV (Combined) | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (day 1) | 14 Titers |
| TIV Group | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (day 22) | 329 Titers |
| TIV Group | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (day 22) | 186 Titers |
| TIV Group | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H1N1 strain (day 1) | 22 Titers |
| TIV Group | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | A/H3N2 strain (day 1) | 15 Titers |
| TIV Group | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (day 1) | 16 Titers |
| TIV Group | Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects | B strain (day 22) | 124 Titers |
Primary
Percentage of Subjects With HI Titers ≥40
Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is \>70%.
Time frame: Day 22 postvaccination
Population: This analysis was done on PP population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV_lot1 | Percentage of Subjects With HI Titers ≥40 | A/H1N1 strain (day 1) | 36 Percentages |
| cTIV_lot1 | Percentage of Subjects With HI Titers ≥40 | A/H1N1 strain (day 22) | 97 Percentages |
| cTIV_lot1 | Percentage of Subjects With HI Titers ≥40 | A/H3N2 strain (day 1) | 19 Percentages |
| cTIV_lot1 | Percentage of Subjects With HI Titers ≥40 | A/H3N2 strain (day 22) | 92 Percentages |
| cTIV_lot1 | Percentage of Subjects With HI Titers ≥40 | B strain (day 1) | 25 Percentages |
| cTIV_lot1 | Percentage of Subjects With HI Titers ≥40 | B strain (day 22) | 92 Percentages |
| cTIV_lot 2 | Percentage of Subjects With HI Titers ≥40 | A/H3N2 strain (day 22) | 93 Percentages |
| cTIV_lot 2 | Percentage of Subjects With HI Titers ≥40 | A/H1N1 strain (day 1) | 38 Percentages |
| cTIV_lot 2 | Percentage of Subjects With HI Titers ≥40 | B strain (day 22) | 94 Percentages |
| cTIV_lot 2 | Percentage of Subjects With HI Titers ≥40 | B strain (day 1) | 31 Percentages |
| cTIV_lot 2 | Percentage of Subjects With HI Titers ≥40 | A/H3N2 strain (day 1) | 31 Percentages |
| cTIV_lot 2 | Percentage of Subjects With HI Titers ≥40 | A/H1N1 strain (day 22) | 97 Percentages |
| cTIV_lot3 | Percentage of Subjects With HI Titers ≥40 | A/H3N2 strain (day 1) | 28 Percentages |
| cTIV_lot3 | Percentage of Subjects With HI Titers ≥40 | B strain (day 22) | 93 Percentages |
| cTIV_lot3 | Percentage of Subjects With HI Titers ≥40 | B strain (day 1) | 25 Percentages |
| cTIV_lot3 | Percentage of Subjects With HI Titers ≥40 | A/H1N1 strain (day 22) | 94 Percentages |
| cTIV_lot3 | Percentage of Subjects With HI Titers ≥40 | A/H3N2 strain (day 22) | 91 Percentages |
| cTIV_lot3 | Percentage of Subjects With HI Titers ≥40 | A/H1N1 strain (day 1) | 34 Percentages |
| cTIV (Combined) | Percentage of Subjects With HI Titers ≥40 | B strain (day 22) | 93 Percentages |
| cTIV (Combined) | Percentage of Subjects With HI Titers ≥40 | A/H1N1 strain (day 22) | 96 Percentages |
| cTIV (Combined) | Percentage of Subjects With HI Titers ≥40 | A/H3N2 strain (day 1) | 26 Percentages |
| cTIV (Combined) | Percentage of Subjects With HI Titers ≥40 | A/H3N2 strain (day 22) | 92 Percentages |
| cTIV (Combined) | Percentage of Subjects With HI Titers ≥40 | A/H1N1 strain (day 1) | 36 Percentages |
| cTIV (Combined) | Percentage of Subjects With HI Titers ≥40 | B strain (day 1) | 27 Percentages |
| TIV Group | Percentage of Subjects With HI Titers ≥40 | A/H3N2 strain (day 22) | 97 Percentages |
| TIV Group | Percentage of Subjects With HI Titers ≥40 | B strain (day 1) | 31 Percentages |
| TIV Group | Percentage of Subjects With HI Titers ≥40 | A/H1N1 strain (day 1) | 38 Percentages |
| TIV Group | Percentage of Subjects With HI Titers ≥40 | A/H3N2 strain (day 1) | 28 Percentages |
| TIV Group | Percentage of Subjects With HI Titers ≥40 | A/H1N1 strain (day 22) | 97 Percentages |
| TIV Group | Percentage of Subjects With HI Titers ≥40 | B strain (day 22) | 93 Percentages |
Primary
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine
Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after 1. one dose of cTIV for each of the three vaccine lots separately and 2. one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is \>40%. As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer \<10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination.
Time frame: Day 22 postvaccination
Population: This analysis was done on PP population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV_lot1 | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | A/H1N1 strain | 80 Percentages |
| cTIV_lot1 | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | A/H3N2 strain | 84 Percentages |
| cTIV_lot1 | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | B strain | 79 Percentages |
| cTIV_lot 2 | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | A/H1N1 strain | 81 Percentages |
| cTIV_lot 2 | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | A/H3N2 strain | 79 Percentages |
| cTIV_lot 2 | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | B strain | 81 Percentages |
| cTIV_lot3 | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | A/H1N1 strain | 82 Percentages |
| cTIV_lot3 | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | B strain | 80 Percentages |
| cTIV_lot3 | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | A/H3N2 strain | 78 Percentages |
| cTIV (Combined) | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | A/H3N2 strain | 80 Percentages |
| cTIV (Combined) | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | B strain | 80 Percentages |
| cTIV (Combined) | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | A/H1N1 strain | 81 Percentages |
| TIV Group | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | A/H1N1 strain | 76 Percentages |
| TIV Group | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | B strain | 70 Percentages |
| TIV Group | Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine | A/H3N2 strain | 88 Percentages |
Secondary
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV.
Time frame: Day 1 to Day 7 postvaccination
Population: Analysis was done on safety dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site ecchymosis | 6 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Malaise | 36 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site erythema | 32 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site swelling | 10 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Fatigue | 39 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Chills | 18 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Stayed home due to reaction | 7 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site induration | 11 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site pain | 33 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Headache | 32 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Sweat | 8 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Fever (>=38C) | 1 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Arthralgia | 6 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Other | 13 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Myalgia | 14 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Analgesic Antipyretic medication used | 10 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Any Local | 57 subjects |
| cTIV_lot1 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Any Systemic | 62 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Other | 3 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Any Systemic | 53 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Arthralgia | 8 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site swelling | 7 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site ecchymosis | 7 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site erythema | 18 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Stayed home due to reaction | 3 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Malaise | 29 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site induration | 13 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Fatigue | 29 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Fever (>=38C) | 1 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site pain | 23 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Chills | 13 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Any Local | 40 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Sweat | 15 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Myalgia | 13 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Headache | 31 subjects |
| cTIV_lot 2 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Analgesic Antipyretic medication used | 2 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Arthralgia | 5 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Any Systemic | 55 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Chills | 10 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Malaise | 26 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Headache | 31 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Fever (>=38C) | 2 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Any Local | 37 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site ecchymosis | 3 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site erythema | 16 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site induration | 6 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site swelling | 6 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site pain | 24 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Myalgia | 11 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Sweat | 11 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Fatigue | 32 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Other | 15 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Stayed home due to reaction | 7 subjects |
| cTIV_lot3 | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Analgesic Antipyretic medication used | 10 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site pain | 80 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site ecchymosis | 16 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Stayed home due to reaction | 17 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Myalgia | 38 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Fever (>=38C) | 4 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Any Local | 134 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Arthralgia | 19 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Headache | 94 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Malaise | 91 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Chills | 41 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Sweat | 34 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Any Systemic | 170 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Analgesic Antipyretic medication used | 22 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Fatigue | 100 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site induration | 30 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site erythema | 66 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Other | 31 subjects |
| cTIV (Combined) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site swelling | 23 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Analgesic Antipyretic medication used | 8 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site pain | 10 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Chills | 9 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Any Local | 16 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Stayed home due to reaction | 3 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Malaise | 15 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site swelling | 4 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Fever (>=38C) | 1 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site erythema | 8 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Sweat | 4 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Myalgia | 8 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Any Systemic | 29 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Headache | 16 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site induration | 6 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Other | 9 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Arthralgia | 2 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Injection site ecchymosis | 5 subjects |
| TIV Group | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Fatigue | 17 subjects |
Secondary
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.
Time frame: Day 1 - Day 181 postvaccination
Population: This analysis was done on safety dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV_lot1 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related SAEs | 0 subjects |
| cTIV_lot1 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Death | 0 subjects |
| cTIV_lot1 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Serious AEs | 2 subjects |
| cTIV_lot1 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related AEs | 45 subjects |
| cTIV_lot1 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | AE leading to withdrawal | 0 subjects |
| cTIV_lot1 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any AEs | 74 subjects |
| cTIV_lot 2 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | AE leading to withdrawal | 1 subjects |
| cTIV_lot 2 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Serious AEs | 14 subjects |
| cTIV_lot 2 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Death | 1 subjects |
| cTIV_lot 2 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any AEs | 62 subjects |
| cTIV_lot 2 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related AEs | 1 subjects |
| cTIV_lot 2 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related SAEs | 0 subjects |
| cTIV_lot3 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Serious AEs | 0 subjects |
| cTIV_lot3 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related SAEs | 0 subjects |
| cTIV_lot3 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related AEs | 10 subjects |
| cTIV_lot3 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Death | 0 subjects |
| cTIV_lot3 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | AE leading to withdrawal | 0 subjects |
| cTIV_lot3 | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any AEs | 13 subjects |
| cTIV (Combined) | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | AE leading to withdrawal | 0 subjects |
| cTIV (Combined) | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Death | 0 subjects |
| cTIV (Combined) | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related AEs | 0 subjects |
| cTIV (Combined) | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any AEs | 6 subjects |
| cTIV (Combined) | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related SAEs | 0 subjects |
| cTIV (Combined) | Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Serious AEs | 2 subjects |