Human Influenza
Conditions
Keywords
Influenza,, Adults,, Elderly,, Immunology,, Safety
Brief summary
The present study is designed to confirm the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years and the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post immunization. The vaccine composition will be based on the World Health Organization (WHO) recommended influenza strains for the 2013/2014 Northern Hemisphere vaccine. The results of this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same, in compliance with the requirements of the current European Union (EU) recommendations for clinical trials related to yearly licensing of influenza vaccines.
Interventions
BIOLOGICALTIVf
Trivalent Influenza Virus Vaccine (purified surface antigen, inactivated, egg-derived)
Sponsors
Novartis Vaccines
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female volunteer aged 18 years or older, mentally competent, who gave written informed consent prior to study entry; * Able to comply with all the study requirements; and * In good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
Exclusion criteria
* Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may have interfered with the subject's ability to participate in the study; * any serious chronic or acute disease (in the judgment of the investigator) including, but not limited to * medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years, or localized prostate cancer that has been clinically stable for \>2 years without treatment) * medically significant advanced congestive heart failure (ie, New York Heart Association (NYHA) class III and IV) * chronic obstructive pulmonary disease (ie, Global initiative for chronic Obstructive Lung Disease (GOLD) stage III and IV) * autoimmune disease (including rheumatoid arthritis and excepting Hashimoto's thyroiditis that had been clinically stable for ≥5 years) * diabetes mellitus type I * poorly controlled diabetes mellitus type II * advanced arteriosclerotic disease * history of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (Down's syndrome), acute or progressive hepatic disease * acute or progressive renal disease * severe neurological (especially Guillain-Barré syndrome) or psychiatric disorder * severe asthma * history of any anaphylactic reaction and/or serious allergic reaction to any component of the study vaccine; * a known or suspected (or had a high risk of developing) impairment/alteration of immune function (excluding those normally associated with advanced age) resulting, for example, from: * receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study, * receipt of immunostimulants within the past 6 months, * receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within the past 3 months and for the full length of the study, or * suspected or known human immunodeficiency virus (HIV) infection or HIV-related disease * Had known or suspected drug or alcohol abuse within the past 2 years; * Had bleeding diathesis or conditions associated with prolonged bleeding time that, in the investigator's opinion, would interfere with the safety of the subject; * was not able to comprehend and to follow all required study procedures for the whole period of the study; * Had a history or any illness that, in the opinion of the investigator, would pose additional risk to the subjects because of participation in the study; * Had the following within the past 6 months: * had any laboratory-confirmed seasonal or pandemic influenza disease * received any seasonal or pandemic influenza vaccine * Had received any other vaccine within 4 weeks prior to enrollment in this study or who were planning to receive any vaccine during the study; * Had acute or chronic infections requiring antiviral therapy within the last 7 days; * Had experienced fever (ie, body temperature \[preferably oral\] ≥38.0°C) within the last 3 days of intended study vaccination; * Had been participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intends to participate in another clinical study at any time during the conduct of this study; * was part of study personnel or has close family members conducting this study; * Had a body mass index (BMI) \>35 kg/m2 (BMI is calculated by dividing the subject's weight in kilograms by the subject's height in meters multiplied by the subject's height in meters); * was pregnant (confirmed by positive urine pregnancy test) or nursing (breast feeding) or was a female of childbearing potential who refused to use an acceptable method of birth control for the whole duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (baseline) and Day 22 (postvaccination) | Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years. |
| Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (postvaccination) /Day 1 (Baseline) | Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVf. Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre vaccination SRH area \>4mm2 achieving at least 50% increase in post vaccination SRH area. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>40% for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years. |
| Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf | Day 22 (postvaccination)/ Day 1 (baseline) | The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 for subjects aged ≥61 years. |
| Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (baseline) and Day 22 (postvaccination) | Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years. |
| Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf | Day 22 (postvaccination)/ Day 1 (baseline) | Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVf. Seroconversion is defined as percentage of subjects with a pre vaccination HI titer \<10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers. The related European (CHMP) criterion for the assessment of immunogenicity is met if\>40 % for adults aged 18 to ≤60 years and\>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post vaccination HI titers. |
| Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22/ Day 1 | The antibody responses following one dose of TIVf were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 for subjects aged ≥61 years. |
| Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Day 1 through Day 4 postvaccination | The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIVf are reported. |
| Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | Day 1(baseline) through Day 22 postvaccination | The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVf is reported. |
Countries
Germany
Participant flow
Recruitment details
Subjects were enrolled from one center in Germany.
Participants by arm
| Arm | Count |
|---|---|
| TIVf (18 to ≤ 60 Years) Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere | 61 |
| TIVf (≥ 61 Years) Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere | 64 |
| Total | 125 |
Baseline characteristics
| Characteristic | TIVf (18 to ≤ 60 Years) | TIVf (≥ 61 Years) | Total |
|---|---|---|---|
| Age, Continuous | 39.2 years STANDARD_DEVIATION 11.2 | 68.2 years STANDARD_DEVIATION 4.7 | 54.1 years STANDARD_DEVIATION 16.9 |
| Sex: Female, Male Female | 29 Participants | 34 Participants | 63 Participants |
| Sex: Female, Male Male | 32 Participants | 30 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 41 / 61 | 24 / 64 |
| serious Total, serious adverse events | 0 / 61 | 0 / 64 |
Outcome results
Primary
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf
The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 for subjects aged ≥61 years.
Time frame: Day 22 (postvaccination)/ Day 1 (baseline)
Population: Analysis was done on the per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TIVf (18 to ≤ 60 Years) | Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf | H1N1 strain | 7.62 Ratio |
| TIVf (18 to ≤ 60 Years) | Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf | H3N2 strain | 3.66 Ratio |
| TIVf (18 to ≤ 60 Years) | Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf | B strain | 2.62 Ratio |
| TIVf (≥ 61 Years) | Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf | H1N1 strain | 3.42 Ratio |
| TIVf (≥ 61 Years) | Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf | H3N2 strain | 3.05 Ratio |
| TIVf (≥ 61 Years) | Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf | B strain | 2.33 Ratio |
Primary
Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
The antibody responses following one dose of TIVf were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 for subjects aged ≥61 years.
Time frame: Day 22/ Day 1
Population: Analysis was done on the per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TIVf (18 to ≤ 60 Years) | Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | H3N2 strain | 10 Ratio |
| TIVf (18 to ≤ 60 Years) | Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | B strain | 5.34 Ratio |
| TIVf (18 to ≤ 60 Years) | Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | H1N1 strain | 27 Ratio |
| TIVf (≥ 61 Years) | Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | H3N2 strain | 7.34 Ratio |
| TIVf (≥ 61 Years) | Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | H1N1 strain | 11 Ratio |
| TIVf (≥ 61 Years) | Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | B strain | 2.54 Ratio |
Primary
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf
The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIVf are reported.
Time frame: Day 1 through Day 4 postvaccination
Population: Analysis was done on the safety set population i.e all subjects who have post-vaccination AE or reactogenicity records
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Chills/shivering | 3 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Arthralgia | 5 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Injection site induration | 7 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Headache | 14 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Malaise | 8 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Fatigue | 14 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Injection site pain | 31 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Fever (≥38°C) | 0 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Injection site ecchymosis | 4 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Prophylactic use of analgesic/antipyretics N=61,62 | 0 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Myalgia | 2 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Therapeutic use of analgesics/antipyretics N=61,62 | 3 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Injection site erythema | 2 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Therapeutic use of analgesics/antipyretics N=61,62 | 0 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Injection site pain | 18 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Injection site ecchymosis | 1 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Injection site erythema | 10 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Injection site induration | 8 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Chills/shivering | 0 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Malaise | 1 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Myalgia | 2 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Arthralgia | 1 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Headache | 5 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Fatigue | 6 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Fever (≥38°C) | 0 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf | Prophylactic use of analgesic/antipyretics N=61,62 | 0 Subjects |
Primary
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf
The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVf is reported.
Time frame: Day 1(baseline) through Day 22 postvaccination
Population: Analysis was done on the safety set population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | Any SAE | 0 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | AE leading to premature withdrawal | 0 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | Possibly/Probably related SAE | 0 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | Possibly/Probably related AE | 1 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | Medically attended AE | 1 Subjects |
| TIVf (18 to ≤ 60 Years) | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | Any AE | 3 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | AE leading to premature withdrawal | 0 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | Any AE | 3 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | Possibly/Probably related AE | 3 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | Any SAE | 0 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | Possibly/Probably related SAE | 0 Subjects |
| TIVf (≥ 61 Years) | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf | Medically attended AE | 0 Subjects |
Primary
Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
Time frame: Day 1 (baseline) and Day 22 (postvaccination)
Population: Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) confirmed influenza during the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVf (18 to ≤ 60 Years) | Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (H1N1 strain) | 95 Percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (H3N2 strain) | 82 Percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (H1N1 strain) | 17 Percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (B strain) | 57 Percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (H3N2 strain) | 20 Percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (B strain) | 92 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (H3N2 strain) | 20 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (H1N1 strain) | 36 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (H1N1 strain) | 80 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (B strain) | 92 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (H3N2 strain) | 84 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (B strain) | 55 Percentages of subjects |
Primary
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
Time frame: Day 1 (baseline) and Day 22 (postvaccination)
Population: Analysis was done on the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVf (18 to ≤ 60 Years) | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (H1N1 strain) | 50 Percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (H1N1 strain) | 100 Percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (H3N2 strain) | 98 Percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (B strain) | 45 Percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (B strain) | 93 Percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (H3N2strain) | 62 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (H3N2 strain) | 100 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (H1N1 strain) | 56 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (B strain) | 80 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 22 (H1N1 strain) | 100 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (H3N2strain) | 73 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | Day 1 (B strain) | 45 Percentages of subjects |
Primary
Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVf. Seroconversion is defined as percentage of subjects with a pre vaccination HI titer \<10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers. The related European (CHMP) criterion for the assessment of immunogenicity is met if\>40 % for adults aged 18 to ≤60 years and\>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post vaccination HI titers.
Time frame: Day 22 (postvaccination)/ Day 1 (baseline)
Population: Analysis was done on the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVf (18 to ≤ 60 Years) | Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf | H1N1 strain | 78 percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf | H3N2 strain | 82 percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf | B strain | 53 percentages of subjects |
| TIVf (≥ 61 Years) | Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf | H1N1 strain | 70 percentages of subjects |
| TIVf (≥ 61 Years) | Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf | H3N2 strain | 56 percentages of subjects |
| TIVf (≥ 61 Years) | Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf | B strain | 27 percentages of subjects |
Primary
Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVf. Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre vaccination SRH area \>4mm2 achieving at least 50% increase in post vaccination SRH area. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>40% for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years.
Time frame: Day 22 (postvaccination) /Day 1 (Baseline)
Population: Analysis was done on the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVf (18 to ≤ 60 Years) | Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | H1N1 strain | 85 Percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | H3N2 strain | 88 Percentages of subjects |
| TIVf (18 to ≤ 60 Years) | Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | B strain | 68 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | H1N1 strain | 58 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | H3N2 strain | 73 Percentages of subjects |
| TIVf (≥ 61 Years) | Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf | B strain | 67 Percentages of subjects |