Influenza Disease; Flu
Conditions
Keywords
influenza, flu
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of cell culture-derived, inactivated, subunit influenza vaccine in comparison to licensed Fluvirin vaccine administered to healthy adults ages 18 \< 50 years.
Interventions
BIOLOGICALInfluenza Virus Vaccine
Sponsors
Novartis Vaccines and Diagnostics (formerly Chiron Vaccines)
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
18 to \<50 years of age; 1. able to comprehend and follow all required study procedures; 2. able and willing to provide written informed consent prior to study entry; 3. available for all the visits scheduled in the study; 4. in general good health as determined by: 1. subject-reported medical history, 2. physical examination by a qualified study nurse, a physician's assistant, or a physician, 3. clinical judgment of the investigator; among all female volunteers, evidence of a negative pregnancy test conducted on the same day as and prior to study vaccination, and agreement to practice adequate contraception for at least 6 weeks after vaccination as further described in the protocol.
Exclusion criteria
1. received influenza vaccine within the past 6 months; 2. laboratory-confirmed influenza disease in the past 6 months; 3. any acute respiratory disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or fever ≥38°C (100.4°F) within the past 3 days; 4. receipt of another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever was longer, prior to enrollment, and unwilling to refuse participation in another investigational study through the end of the study; 5. any history of or current serious disease, such as: d) cancer (except for benign or localized skin cancer), e) autoimmune disease (including rheumatoid arthritis), f) advanced arteriosclerotic disease or diabetes mellitus, g) chronic obstructive pulmonary disease (COPD), h) acute, chronic, or progressive hepatic disease, i) acute, chronic, or progressive renal disease, j) congestive heart failure, k) bleeding diathesis, l) an inherited genetic anomaly (known cytogenic disorders, e.g., Down's Syndrome), m) any other serious, acute, or chronic disease including progressive neurological disease or seizure disorder unrelated to fever; 6. surgery or hospitalization planned during the study period; 7. history of any anaphylaxis, serious vaccine reactions, vaccine-associated oculorespiratory syndrome, or allergy to eggs, egg products, mercury-containing compounds (such as sodium-ethyl-mercuro-thio-salicylate), or any other vaccine component or component of the potential packaging materials (latex); 8. known or suspected disease of the immune system, or receiving immunosuppressive therapy, including use of: n) systemic corticosteroids, known to be associated with suppression of the hypothalamic-pituitary-adrenal (HPA) axis (i.e., systemic corticosteroids \[15 mg/day of prednisone or its equivalent\] or chronic use of inhaled high potency corticosteroids \[budesonide 800 μg/day or fluticasone 750 μg/day\]), both within the previous 60 days, o) receipt of immunostimulants within 60 days, p) receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the 3 months prior to study entry or anticipated during the full length of the study; 9. at high risk for developing an immunocompromising disease; 10. history of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives; 11. pregnant or breastfeeding; 12. if female of childbearing potential, refusal to use a reliable contraceptive method, as described further in the protocol, during the first 6 weeks after vaccination; 13. if female of childbearing potential and sexually active, has not used any of the following birth control methods for the specified time period prior to study entry: 1. hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), or intrauterine device (e.g., IUD) for 2 months or more prior to study entry, 2. monogamous relationship with vasectomized partner: partner has been vasectomized for 6 months or more prior to the subject's study entry; 14. obese (e.g., with a body mass index \[BMI\] ≥35, where BMI reflects obesity and not high muscle mass); 15. any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | 3 weeks postvaccination (Day 22) | Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV\_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay. |
| Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | 3 weeks postvaccination (Day 22) | Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV\_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | 3 weeks postvaccination (Day 22) | Antibody titers as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay. |
| Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | 3 weeks postvaccination (Day 22) | Antibody titers as assessed by egg-derived antigen and cell-derived antigen HI assay. This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is \>70%. According to the US Center for Biologics Evaluation and Research (CBER) guideline, the criterion is also met if the lower limit of the 95% CI for percentages of subjects achieving seroprotection (HI antibody titer ≥1:40) is ≥70%. |
| Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | 3 weeks postvaccination (Day 22) | Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is \> 2.5. |
| Number of Subjects Reporting Local and Systemic Reactions | 7 days postvaccination | Safety and tolerability of cTIV and eTIV\_f postvaccination. Difference between demography and safety numbers was due to one misrandomization. |
| Percentages of Subjects With Seroconversion. | 3 weeks postvaccination (Day 22) | As the definition for seroconversion/significant increase from CHMP guideline CPMP/BWP/214/96 corresponds to that of seroconversion from the May 2007 CBER guidance, the analysis of this immunogenicity endpoint is presented as seroconversion. Seroconversion is defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40, or prevaccination HI titer ≥10 and a ≥4-fold increase in postvaccination HI antibody titer, on day 22. CBER criterion is met if the lower limit of the 95% CI for percentages of subjects achieving seroconversion for HI antibody (at least a 4-fold rise in HI antibody titer) postvaccination is ≥40%. CHMP criterion is also met if the percentages of subjects achieving seroconversion is \>40%. |
| Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | 3 weeks postvaccination (Day 22) | Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is \> 2.5. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| cTIV Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV). | 308 |
| eTIV_f Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f). | 305 |
| Total | 613 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | cTIV | eTIV_f | Total |
|---|---|---|---|
| Age, Continuous | 33.8 years STANDARD_DEVIATION 8.8 | 34.2 years STANDARD_DEVIATION 9.3 | 34 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 196 Participants | 205 Participants | 401 Participants |
| Sex: Female, Male Male | 112 Participants | 100 Participants | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 236 / 309 | 237 / 304 |
| serious Total, serious adverse events | 3 / 309 | 5 / 304 |
Outcome results
Primary
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV\_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
Time frame: 3 weeks postvaccination (Day 22)
Population: Analysis was done on per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| cTIV | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H1N1 (egg-derived assay) | 263 Titer |
| cTIV | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H3N2 (egg-derived assay) | 199 Titer |
| cTIV | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | B (egg-derived assay) | 185 Titer |
| cTIV | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H1N1 (cell-culture-derived assay) | 478 Titer |
| cTIV | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H3N2 (cell-culture-derived assay) | 306 Titer |
| cTIV | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | B (cell-culture-derived assay) | 180 Titer |
| eTIV_f | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H3N2 (cell-culture-derived assay) | 444 Titer |
| eTIV_f | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H1N1 (egg-derived assay) | 310 Titer |
| eTIV_f | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H1N1 (cell-culture-derived assay) | 518 Titer |
| eTIV_f | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H3N2 (egg-derived assay) | 316 Titer |
| eTIV_f | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | B (cell-culture-derived assay) | 135 Titer |
| eTIV_f | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | B (egg-derived assay) | 159 Titer |
Comparison: The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group.95% CI: [0.7, 1.03]ANCOVA
Comparison: The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group.95% CI: [0.52, 0.76]ANCOVA
Comparison: The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group.95% CI: [0.98, 1.38]ANCOVA
Comparison: The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group.95% CI: [0.76, 1.12]ANCOVA
Comparison: The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group.95% CI: [0.57, 0.83]ANCOVA
Comparison: The following hypotheses were tested for B strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group.95% CI: [1.13, 1.58]ANCOVA
Primary
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV\_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
Time frame: 3 weeks postvaccination (Day 22)
Population: Analysis was done on per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| cTIV | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H1N1 (egg-derived assay) | 259 Titer |
| cTIV | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H3N2 (egg-derived assay) | 181 Titer |
| cTIV | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | B (egg-derived assay) | 179 Titer |
| cTIV | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H1N1 (cell-culture-derived assay) | 468 Titer |
| cTIV | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H3N2 (cell-culture-derived assay) | 287 Titer |
| cTIV | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | B (cell-culture-derived assay) | 176 Titer |
| eTIV_f | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H3N2 (cell-culture-derived assay) | 468 Titer |
| eTIV_f | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H1N1 (egg-derived assay) | 306 Titer |
| eTIV_f | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H1N1 (cell-culture-derived assay) | 508 Titer |
| eTIV_f | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H3N2 (egg-derived assay) | 320 Titer |
| eTIV_f | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | B (cell-culture-derived assay) | 134 Titer |
| eTIV_f | Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | B (egg-derived assay) | 157 Titer |
Comparison: The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group.95% CI: [0.7, 1.04]ANOVA
Comparison: The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group.95% CI: [0.46, 0.7]ANOVA
Comparison: The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group.95% CI: [0.95, 1.36]ANOVA
Comparison: The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group.95% CI: [0.76, 1.12]ANOVA
Comparison: The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group.95% CI: [0.5, 0.75]ANOVA
Comparison: The following hypotheses were tested for B strain as measured by cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group.95% CI: [1.09, 1.57]ANOVA
Secondary
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is \> 2.5.
Time frame: 3 weeks postvaccination (Day 22)
Population: Analysis was done on per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| cTIV | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H1N1 (egg-derived assay) | 7.76 Ratio |
| cTIV | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H3N2 (egg-derived assay) | 18 Ratio |
| cTIV | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | B (egg-derived assay) | 11 Ratio |
| cTIV | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H1N1 (cell-culture-derived assay) | 8.76 Ratio |
| cTIV | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H3N2 (cell-culture-derived assay) | 18 Ratio |
| cTIV | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | B (cell-culture-derived assay) | 10 Ratio |
| eTIV_f | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H3N2 (cell-culture-derived assay) | 22 Ratio |
| eTIV_f | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H1N1 (egg-derived assay) | 9.32 Ratio |
| eTIV_f | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H1N1 (cell-culture-derived assay) | 9.64 Ratio |
| eTIV_f | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | A/H3N2 (egg-derived assay) | 25 Ratio |
| eTIV_f | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | B (cell-culture-derived assay) | 7.46 Ratio |
| eTIV_f | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method. | B (egg-derived assay) | 8.86 Ratio |
Secondary
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is \> 2.5.
Time frame: 3 weeks postvaccination (Day 22)
Population: Analysis was done on per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| cTIV | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H1N1 (egg-derived assay) | 8.06 Ratio |
| cTIV | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H3N2 (egg-derived assay) | 18 Ratio |
| cTIV | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | B (egg-derived assay) | 11 Ratio |
| cTIV | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H1N1 (cell-culture-derived assay) | 9.21 Ratio |
| cTIV | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H3N2 (cell-culture-derived assay) | 18 Ratio |
| cTIV | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | B (cell-culture-derived assay) | 10 Ratio |
| eTIV_f | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H3N2 (cell-culture-derived assay) | 22 Ratio |
| eTIV_f | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H1N1 (egg-derived assay) | 9.65 Ratio |
| eTIV_f | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H1N1 (cell-culture-derived assay) | 10 Ratio |
| eTIV_f | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | A/H3N2 (egg-derived assay) | 25 Ratio |
| eTIV_f | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | B (cell-culture-derived assay) | 7.6 Ratio |
| eTIV_f | Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. | B (egg-derived assay) | 9.15 Ratio |
Secondary
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
Antibody titers as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
Time frame: 3 weeks postvaccination (Day 22)
Population: Analysis was done on per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| cTIV | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H1N1 (Day 1) (egg-derived assay) | 32 Titer |
| cTIV | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H1N1 (Day 22) (egg-derived assay) | 259 Titer |
| cTIV | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H1N1 (Day 1) (cell-culture-derived assay) | 51 Titer |
| cTIV | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H1N1 (Day 22) (cell-culture-derived assay) | 468 Titer |
| cTIV | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H3N2 (Day 1) (egg derived assay) | 10 Titer |
| cTIV | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H3N2 (Day 22) (egg-derived assay) | 181 Titer |
| cTIV | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H3N2 (Day 1) (cell-culture-derived assay) | 16 Titer |
| cTIV | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H3N2 (Day 22) (cell-culture-derived assay) | 287 Titer |
| cTIV | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | B (Day 1) (egg-derived assay) | 16 Titer |
| cTIV | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | B (Day 22) (egg-derived assay) | 179 Titer |
| cTIV | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | B (Day 1) (cell-culture-derived assay) | 17 Titer |
| cTIV | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | B (Day 22) (cell-culture-derived assay) | 176 Titer |
| eTIV_f | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | B (Day 1) (cell-culture-derived assay) | 18 Titer |
| eTIV_f | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H1N1 (Day 1) (egg-derived assay) | 32 Titer |
| eTIV_f | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H3N2 (Day 1) (cell-culture-derived assay) | 21 Titer |
| eTIV_f | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H1N1 (Day 22) (egg-derived assay) | 306 Titer |
| eTIV_f | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | B (Day 22) (egg-derived assay) | 157 Titer |
| eTIV_f | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H1N1 (Day 1) (cell-culture-derived assay) | 50 Titer |
| eTIV_f | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H3N2 (Day 22) (cell-culture-derived assay) | 468 Titer |
| eTIV_f | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H1N1 (Day 22) (cell-culture-derived assay) | 508 Titer |
| eTIV_f | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | B (Day 22) (cell-culture-derived assay) | 134 Titer |
| eTIV_f | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H3N2 (Day 1) (egg derived assay) | 13 Titer |
| eTIV_f | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | B (Day 1) (egg-derived assay) | 17 Titer |
| eTIV_f | Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method | A/H3N2 (Day 22) (egg-derived assay) | 320 Titer |
Secondary
Number of Subjects Reporting Local and Systemic Reactions
Safety and tolerability of cTIV and eTIV\_f postvaccination. Difference between demography and safety numbers was due to one misrandomization.
Time frame: 7 days postvaccination
Population: Analysis was done on safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Myalgia | 68 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Cough | 26 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Arthralgia | 26 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Injection site induration | 27 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Headache | 109 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Nausea | 31 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Sweating | 15 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Chest tightness | 14 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Injection site swelling | 13 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Difficulty breathing | 10 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Fatigue | 59 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Sore Throat | 53 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Injection site pain | 155 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Facial Edema | 1 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Ecchymosis | 12 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Red Eye | 3 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Chills | 14 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Fever (>=38°C)) | 3 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Wheezing | 7 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Stayed at home due to reaction | 7 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Malaise | 76 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Analgesic medicine used | 102 Subjects |
| cTIV | Number of Subjects Reporting Local and Systemic Reactions | Injection site erythema | 34 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Analgesic medicine used | 109 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Nausea | 35 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Cough | 35 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Wheezing | 9 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Sweating | 23 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Ecchymosis | 26 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Injection site erythema | 48 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Injection site induration | 19 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Injection site swelling | 16 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Injection site pain | 169 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Chills | 26 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Malaise | 72 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Myalgia | 73 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Arthralgia | 28 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Headache | 121 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Chest tightness | 11 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Difficulty breathing | 6 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Sore Throat | 45 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Facial Edema | 1 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Red Eye | 6 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Fever (>=38°C)) | 3 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Stayed at home due to reaction | 9 Subjects |
| eTIV_f | Number of Subjects Reporting Local and Systemic Reactions | Fatigue | 67 Subjects |
Secondary
Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.
Antibody titers as assessed by egg-derived antigen and cell-derived antigen HI assay. This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is \>70%. According to the US Center for Biologics Evaluation and Research (CBER) guideline, the criterion is also met if the lower limit of the 95% CI for percentages of subjects achieving seroprotection (HI antibody titer ≥1:40) is ≥70%.
Time frame: 3 weeks postvaccination (Day 22)
Population: Analysis was done on per protocol set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV | Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | A/H1N1 (egg-derived assay) | 96 Percentages |
| cTIV | Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | A/H3N2 (egg-derived assay) | 91 Percentages |
| cTIV | Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | B (egg-derived assay) | 94 Percentages |
| cTIV | Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | A/H1N1 (cell-culture-derived assay) | 99 Percentages |
| cTIV | Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | A/H3N2 (cell-culture-derived assay) | 98 Percentages |
| cTIV | Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | B(cell-culture-derived assay) | 97 Percentages |
| eTIV_f | Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | A/H3N2 (cell-culture-derived assay) | 99 Percentages |
| eTIV_f | Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | A/H1N1 (egg-derived assay) | 98 Percentages |
| eTIV_f | Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | A/H1N1 (cell-culture-derived assay) | 99 Percentages |
| eTIV_f | Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | A/H3N2 (egg-derived assay) | 96 Percentages |
| eTIV_f | Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | B(cell-culture-derived assay) | 91 Percentages |
| eTIV_f | Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40. | B (egg-derived assay) | 93 Percentages |
Secondary
Percentages of Subjects With Seroconversion.
As the definition for seroconversion/significant increase from CHMP guideline CPMP/BWP/214/96 corresponds to that of seroconversion from the May 2007 CBER guidance, the analysis of this immunogenicity endpoint is presented as seroconversion. Seroconversion is defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40, or prevaccination HI titer ≥10 and a ≥4-fold increase in postvaccination HI antibody titer, on day 22. CBER criterion is met if the lower limit of the 95% CI for percentages of subjects achieving seroconversion for HI antibody (at least a 4-fold rise in HI antibody titer) postvaccination is ≥40%. CHMP criterion is also met if the percentages of subjects achieving seroconversion is \>40%.
Time frame: 3 weeks postvaccination (Day 22)
Population: Analysis was done on per protocol set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV | Percentages of Subjects With Seroconversion. | A/H1N1 (egg-derived assay) | 62 Percentages |
| cTIV | Percentages of Subjects With Seroconversion. | A/H3N2 (egg-derived assay) | 85 Percentages |
| cTIV | Percentages of Subjects With Seroconversion. | B (egg-derived assay) | 77 Percentages |
| cTIV | Percentages of Subjects With Seroconversion. | A/H1N1 (cell-culture-derived assay) | 62 Percentages |
| cTIV | Percentages of Subjects With Seroconversion. | A/H3N2 (cell-culture-derived assay) | 89 Percentages |
| cTIV | Percentages of Subjects With Seroconversion. | B(cell-culture-derived assay) | 78 Percentages |
| eTIV_f | Percentages of Subjects With Seroconversion. | A/H3N2 (cell-culture-derived assay) | 90 Percentages |
| eTIV_f | Percentages of Subjects With Seroconversion. | A/H1N1 (egg-derived assay) | 65 Percentages |
| eTIV_f | Percentages of Subjects With Seroconversion. | A/H1N1 (cell-culture-derived assay) | 64 Percentages |
| eTIV_f | Percentages of Subjects With Seroconversion. | A/H3N2 (egg-derived assay) | 92 Percentages |
| eTIV_f | Percentages of Subjects With Seroconversion. | B(cell-culture-derived assay) | 72 Percentages |
| eTIV_f | Percentages of Subjects With Seroconversion. | B (egg-derived assay) | 76 Percentages |