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| Name | Class |
|---|---|
| Novartis Vaccines and Diagnostics (formerly Chiron Vaccines) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cTIV | Experimental | Received one dose of cell-culture derived trivalent influenza vaccine (cTIV). |
|
| TIV | Active Comparator | Received one dose of egg-derived trivalent vaccine (TIV). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Virus Vaccine | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 weeks postvaccination (Day 22) |
| 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. | 3 weeks postvaccination (Day 22) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
18 to <50 years of age;
able to comprehend and follow all required study procedures;
able and willing to provide written informed consent prior to study entry;
available for all the visits scheduled in the study;
in general good health as determined by:
Exclusion Criteria:
received influenza vaccine within the past 6 months;
laboratory-confirmed influenza disease in the past 6 months;
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;
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;
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;
surgery or hospitalization planned during the study period;
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);
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;
at high risk for developing an immunocompromising disease;
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;
pregnant or breastfeeding;
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;
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:
obese (e.g., with a body mass index [BMI] ≥35, where BMI reflects obesity and not high muscle mass);
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.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bardstown | Kentucky | 40004 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19673652 | Result | Reisinger KS, Block SL, Izu A, Groth N, Holmes SJ. Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity. J Infect Dis. 2009 Sep 15;200(6):849-57. doi: 10.1086/605506. |
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| ID | Title | Description |
|---|---|---|
| FG000 | cTIV | Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV). |
| FG001 | eTIV_f | Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | cTIV | Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV). |
| BG001 | eTIV_f | Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis was done on per protocol set | Posted | Geometric Mean | 95% Confidence Interval | Titer | 3 weeks postvaccination (Day 22) |
|
All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | cTIV | Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (9.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 3 weeks postvaccination (Day 22) |
| 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. | 3 weeks postvaccination (Day 22) |
| 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. | 3 weeks postvaccination (Day 22) |
| 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%. | 3 weeks postvaccination (Day 22) |
| 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%. | 3 weeks postvaccination (Day 22) |
| 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. | 7 days postvaccination |
| Pittsburgh |
| Pennsylvania |
| 15241 |
| United States |
| Salt Lake City | Utah | 84109 | United States |
| Salt Lake City | Utah | 84121 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
|
|
|
| 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. | Analysis was done on per protocol set | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 3 weeks postvaccination (Day 22) |
|
|
|
| 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. | Analysis was done on per protocol set | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 3 weeks postvaccination (Day 22) |
|
|
|
| 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. | Analysis was done on per protocol set | Posted | Geometric Mean | 95% Confidence Interval | Titer | 3 weeks postvaccination (Day 22) |
|
|
|
| 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%. | Analysis was done on per protocol set | Posted | Number | 95% Confidence Interval | Percentages | 3 weeks postvaccination (Day 22) |
|
|
|
| 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%. | Analysis was done on per protocol set | Posted | Number | 95% Confidence Interval | Percentages | 3 weeks postvaccination (Day 22) |
|
|
|
| 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. | Analysis was done on per protocol set | Posted | Geometric Mean | 95% Confidence Interval | Titer | 3 weeks postvaccination (Day 22) |
|
|
|
|
| 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. | Analysis was done on safety set | Posted | Number | Subjects | 7 days postvaccination |
|
|
|
| 3 |
| 309 |
| 236 |
| 309 |
| EG001 | eTIV_f | Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f). | 5 | 304 | 237 | 304 |
| Cellulitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
|
| Nasal septal operation | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (9.0) | Systematic Assessment |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| B (egg-derived assay) |
|
| A/H1N1 (cell-culture-derived assay) |
|
| A/H3N2 (cell-culture-derived assay) |
|
| B (cell-culture-derived assay) |
|
| B (egg-derived assay) |
|
| A/H1N1 (cell-culture-derived assay) |
|
| A/H3N2 (cell-culture-derived assay) |
|
| B (cell-culture-derived assay) |
|
| A/H1N1 (Day 1) (cell-culture-derived assay) |
|
| A/H1N1 (Day 22) (cell-culture-derived assay) |
|
| A/H3N2 (Day 1) (egg derived assay) |
|
| A/H3N2 (Day 22) (egg-derived assay) |
|
| A/H3N2 (Day 1) (cell-culture-derived assay) |
|
| A/H3N2 (Day 22) (cell-culture-derived assay) |
|
| B (Day 1) (egg-derived assay) |
|
| B (Day 22) (egg-derived assay) |
|
| B (Day 1) (cell-culture-derived assay) |
|
| B (Day 22) (cell-culture-derived assay) |
|
| B (egg-derived assay) |
|
| A/H1N1 (cell-culture-derived assay) |
|
| A/H3N2 (cell-culture-derived assay) |
|
| B(cell-culture-derived assay) |
|
| B (egg-derived assay) |
|
| A/H1N1 (cell-culture-derived assay) |
|
| A/H3N2 (cell-culture-derived assay) |
|
| B(cell-culture-derived assay) |
|
| B (egg-derived assay) |
|
| A/H1N1 (cell-culture-derived assay) |
|
| A/H3N2 (cell-culture-derived assay) |
|
| B (cell-culture-derived assay) |
|
| 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. | ANCOVA | Ratio of GMT | 0.63 | 2-Sided | 95 | 0.52 | 0.76 | Non-Inferiority or Equivalence | To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5. |
| 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. | ANCOVA | Ratio of GMT | 1.16 | 2-Sided | 95 | 0.98 | 1.38 | Non-Inferiority or Equivalence | To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5. |
| 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. | ANCOVA | To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5. | Ratio of GMT | 0.92 | 2-Sided | 95 | 0.76 | 1.12 | Non-Inferiority or Equivalence | To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5. |
| 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. | ANCOVA | Ratio of GMT | 0.69 | 2-Sided | 95 | 0.57 | 0.83 | Non-Inferiority or Equivalence | To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5. |
| 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. | ANCOVA | Ratio of GMT | 1.33 | 2-Sided | 95 | 1.13 | 1.58 | Non-Inferiority or Equivalence | To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5. |
| Injection site induration |
|
| Injection site swelling |
|
| Injection site pain |
|
| Chills |
|
| Malaise |
|
| Myalgia |
|
| Arthralgia |
|
| Headache |
|
| Sweating |
|
| Fatigue |
|
| Nausea |
|
| Cough |
|
| Wheezing |
|
| Chest tightness |
|
| Difficulty breathing |
|
| Sore Throat |
|
| Facial Edema |
|
| Red Eye |
|
| Fever (>=38°C)) |
|
| Stayed at home due to reaction |
|
| Analgesic medicine used |
|