Influenza
Conditions
Keywords
Trivalent inactivated subunit influenza vaccines, 50 years and above, healthy subjects
Brief summary
Demonstrate non-inferiority of the post-vaccination (Day 22) Hemagglutination inhibition (HI) Geometric Mean Titers (GMTs) of trivalent, inactivated, subunit influenza vaccine (TIV) over the corresponding GMTs of the comparator vaccine for all three strains, in healthy adults aged 50 years and above. Demonstrate non-inferiority of the percentages of subjects achieving seroconversion in antibody titers at Day 22 in the TIV group over the corresponding percentages of subjects in the comparator group for all three strains, in healthy adults aged 50 years and above.
Interventions
BIOLOGICALFluvirin(TIVf)
BIOLOGICALAgriflu (TIV)
Sponsors
Novartis Vaccines
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males and females aged 50 years and above, mentally competent, willing and able to give written informed consent prior to study entry and after the nature of the study has been explained according to local regulatory requirements. * Individuals able to comply with all the study requirements. * Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Exclusion criteria
* Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study. * Individuals with any progressive or severe neurologic disorder, seizure disorder or Guillain-Barré syndrome. * Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study. * Individuals who have received any seasonal or pandemic influenza vaccine or have had a laboratory confirmed seasonal or pandemic influenza disease within the past 6 months. * Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study. * Individuals with positive HIV test result, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy within 6 months or use of any parenteral or oral corticosteroids within the previous 30 days. * Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. * Individuals with any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). * Individuals who have any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder. * Individuals with history of any anaphylactic adverse event and/or serious allergic adverse event following a vaccination, a proven hypersensitivity to any component of the study vaccine (eg, to eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate) or latex allergy. * Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. * Receipt of nonstudy vaccines (with the exception of post-exposure vaccination in a medical emergency, eg, hepatitis, rabies, tetanus) within 3 weeks prior to Visit 1. * Individuals who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks. * Individuals who have received antibiotics within 6 days before vaccination. * Individuals with body temperature (axillary temperature) ≥38 degrees Celsius (≥ 100.4° F) within the last 3 days of intended study vaccination. * BMI \> 35 kg/m2. * Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures, for the whole duration of the study. Adequate contraception is defined as hormonal (eg, oral, injection, transdermal patch, implant, cervical ring), barrier (eg, condom with spermicide or diaphragm with spermicide), intrauterine device (IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry; Abstinence. * Individuals who are part of study personnel or close family members conducting this study. * Individuals with history of substance or alcohol abuse within the past 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years | Day 22 | Non-inferiority of Postvaccination Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV (Trivalent Subunit Inactivated Influenza Vaccine) Group Over the Corresponding TIVf Group for All Three Strains, three weeks after vaccination (day 22). The upper limit of the two-sided 95% confidence interval (CI) on the ratio of GMTs (GMT TIVf/GMT TIV) should not exceed the non-inferiority margin of 1.5. |
| Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years | Day 22 | Non-Inferiority was measured as the percentages of subjects who achieved seroconversion in HI titers three weeks (day 22) after vaccination of TIV compared with TIVf, against each of three vaccine strains. Seroconversion is defined as a prevaccination titer \<10 and postvaccination HI ≥40 or as a prevaccination titer ≥10 and at minimum four-fold rise in postvaccination antibody titer. The upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - SeroconversionTIV) should not exceed 10%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | Day 22 | Percentage of subjects achieving HI seroconversion against each of three vaccine strains was measured three weeks after vaccination of TIV and TIVf vaccine (day 22). Percentage of subjects who achieved HI titer ≥1:40 against each of three vaccine strains was measured three weeks after one vaccination of TIV and TIVf vaccine. According to Center for Biologics Evaluation and Research recommendations (CBER 2007), the criterion for seroconversion is considered met if the lower limit of the two-sided 95% CI for the percentage of subjects with HI seroconversion is ≥40% (\<65 years) or ≥30% (≥65 years). As per the CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects who achieved HI titer ≥ 1:40 should be ≥70% (\<65 years) or ≥60% (≥65 years). |
| Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | Day 22 | Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs against each of three vaccine strains, three weeks after vaccination of TIV and TIVf vaccine (day 22). |
| Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Day 1 to 7 postvaccination | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIV and control. |
Countries
Czechia, Philippines, South Africa, Thailand
Participant flow
Recruitment details
A total of 24 sites with 3 sites in Thailand, 4 sites in Philippines, 15 sites in South Africa and 2 sites in Czech Republic.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Agriflu Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV | 1,452 |
| Fluvirin Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf | 1,450 |
| Total | 2,902 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Not Eligible | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 6 |
Baseline characteristics
| Characteristic | Agriflu | Fluvirin | Total |
|---|---|---|---|
| Age, Continuous | 64.2 year STANDARD_DEVIATION 8.9 | 64.2 year STANDARD_DEVIATION 8.9 | 64.2 year STANDARD_DEVIATION 8.9 |
| Sex: Female, Male Female | 943 Participants | 893 Participants | 1836 Participants |
| Sex: Female, Male Male | 509 Participants | 557 Participants | 1066 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 471 / 1,452 | 467 / 1,445 | 938 / 2,897 |
| serious Total, serious adverse events | 3 / 1,452 | 5 / 1,445 | 8 / 2,897 |
Outcome results
Primary
Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years
Non-inferiority of Postvaccination Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV (Trivalent Subunit Inactivated Influenza Vaccine) Group Over the Corresponding TIVf Group for All Three Strains, three weeks after vaccination (day 22). The upper limit of the two-sided 95% confidence interval (CI) on the ratio of GMTs (GMT TIVf/GMT TIV) should not exceed the non-inferiority margin of 1.5.
Time frame: Day 22
Population: Analysis was done on the per-protocol set 1 (PPS1) , ie, the subjects who received the vaccine correctly; provided evaluable serum samples at visit 2; and had no major protocol violations as defined prior to analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Agriflu | Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years | A/H1N1(1401, 1397) | 315 Titers |
| Agriflu | Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years | A/H3N2(1401, 1397) | 697 Titers |
| Agriflu | Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years | B | 36 Titers |
| Fluvirin | Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years | A/H1N1(1401, 1397) | 581 Titers |
| Fluvirin | Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years | A/H3N2(1401, 1397) | 1048 Titers |
| Fluvirin | Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years | B | 36 Titers |
Comparison: Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H1N1 at day 2295% CI: [1.66, 2.06]ANCOVA
Comparison: Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H3N2 at day 2295% CI: [1.38, 1.64]ANCOVA
Comparison: Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain B at day 2295% CI: [0.93, 1.08]ANCOVA
Primary
Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years
Non-Inferiority was measured as the percentages of subjects who achieved seroconversion in HI titers three weeks (day 22) after vaccination of TIV compared with TIVf, against each of three vaccine strains. Seroconversion is defined as a prevaccination titer \<10 and postvaccination HI ≥40 or as a prevaccination titer ≥10 and at minimum four-fold rise in postvaccination antibody titer. The upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - SeroconversionTIV) should not exceed 10%.
Time frame: Day 22
Population: Analysis was done on the PPS2, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at visit 1 and visit 2; and had no major protocol violations as defined prior to analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Agriflu | Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years | A/H1N1(1397,1391) | 75 percentages of subjects |
| Agriflu | Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years | A/H3N2(1398,1390) | 72 percentages of subjects |
| Agriflu | Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years | B(1399,1390) | 41 percentages of subjects |
| Fluvirin | Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years | A/H1N1(1397,1391) | 84 percentages of subjects |
| Fluvirin | Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years | A/H3N2(1398,1390) | 85 percentages of subjects |
| Fluvirin | Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years | B(1399,1390) | 40 percentages of subjects |
Comparison: Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H1N1 at day 2295% CI: [5.6, 11.5]Miettinen and Nurminen
Comparison: Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H3N2 at day 2295% CI: [10.1, 16.1]Miettinen and Nurminen
Comparison: Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain B at day 2295% CI: [-5, 2.3]Miettinen and Nurminen
Secondary
Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine
Percentage of subjects achieving HI seroconversion against each of three vaccine strains was measured three weeks after vaccination of TIV and TIVf vaccine (day 22). Percentage of subjects who achieved HI titer ≥1:40 against each of three vaccine strains was measured three weeks after one vaccination of TIV and TIVf vaccine. According to Center for Biologics Evaluation and Research recommendations (CBER 2007), the criterion for seroconversion is considered met if the lower limit of the two-sided 95% CI for the percentage of subjects with HI seroconversion is ≥40% (\<65 years) or ≥30% (≥65 years). As per the CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects who achieved HI titer ≥ 1:40 should be ≥70% (\<65 years) or ≥60% (≥65 years).
Time frame: Day 22
Population: Analysis was done on the PPS1 for HI Titer ≥1:40 at day 22 and PPS2 for Seroconversion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Agriflu | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H1N1 - Seroconversion(687, 686, 710, 705) | 78 Percentages of subjects |
| Agriflu | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H3N2 - Seroconversion(688, 686, 710, 704) | 78 Percentages of subjects |
| Agriflu | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | B - Seroconversion(688, 686, 711, 704) | 44 Percentages of subjects |
| Agriflu | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H1N1 - HI ≥1:40 (Day 22)[691, 691, 710, 706] | 94 Percentages of subjects |
| Agriflu | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H3N2 - HI ≥1:40 (Day 22)[691, 691, 710, 706] | 99 Percentages of subjects |
| Agriflu | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | B - HI ≥1:40 (Day 22)[691, 691, 711, 706] | 58 Percentages of subjects |
| Fluvirin | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | B - HI ≥1:40 (Day 22)[691, 691, 711, 706] | 59 Percentages of subjects |
| Fluvirin | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H1N1 - HI ≥1:40 (Day 22)[691, 691, 710, 706] | 96 Percentages of subjects |
| Fluvirin | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H1N1 - Seroconversion(687, 686, 710, 705) | 87 Percentages of subjects |
| Fluvirin | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | B - Seroconversion(688, 686, 711, 704) | 45 Percentages of subjects |
| Fluvirin | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H3N2 - Seroconversion(688, 686, 710, 704) | 88 Percentages of subjects |
| Fluvirin | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H3N2 - HI ≥1:40 (Day 22)[691, 691, 710, 706] | 99 Percentages of subjects |
| ≥65 years_Agriflu | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H3N2 - Seroconversion(688, 686, 710, 704) | 66 Percentages of subjects |
| ≥65 years_Agriflu | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | B - Seroconversion(688, 686, 711, 704) | 39 Percentages of subjects |
| ≥65 years_Agriflu | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H1N1 - HI ≥1:40 (Day 22)[691, 691, 710, 706] | 91 Percentages of subjects |
| ≥65 years_Agriflu | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | B - HI ≥1:40 (Day 22)[691, 691, 711, 706] | 59 Percentages of subjects |
| ≥65 years_Agriflu | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H3N2 - HI ≥1:40 (Day 22)[691, 691, 710, 706] | 99 Percentages of subjects |
| ≥65 years_Agriflu | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H1N1 - Seroconversion(687, 686, 710, 705) | 73 Percentages of subjects |
| ≥65 years_Fluvirin | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H3N2 - HI ≥1:40 (Day 22)[691, 691, 710, 706] | 98 Percentages of subjects |
| ≥65 years_Fluvirin | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | B - HI ≥1:40 (Day 22)[691, 691, 711, 706] | 56 Percentages of subjects |
| ≥65 years_Fluvirin | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H3N2 - Seroconversion(688, 686, 710, 704) | 82 Percentages of subjects |
| ≥65 years_Fluvirin | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H1N1 - HI ≥1:40 (Day 22)[691, 691, 710, 706] | 92 Percentages of subjects |
| ≥65 years_Fluvirin | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H1N1 - Seroconversion(687, 686, 710, 705) | 81 Percentages of subjects |
| ≥65 years_Fluvirin | Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | B - Seroconversion(688, 686, 711, 704) | 35 Percentages of subjects |
Secondary
Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs against each of three vaccine strains, three weeks after vaccination of TIV and TIVf vaccine (day 22).
Time frame: Day 22
Population: Analysis was done on the PPS1
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Agriflu | Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H1N1(687, 686, 710, 705) | 18 Ratios |
| Agriflu | Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | B(688, 686, 711, 704) | 3.85 Ratios |
| Agriflu | Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H3N2(688, 686, 710, 704) | 13 Ratios |
| Fluvirin | Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H1N1(687, 686, 710, 705) | 35 Ratios |
| Fluvirin | Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | B(688, 686, 711, 704) | 3.91 Ratios |
| Fluvirin | Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H3N2(688, 686, 710, 704) | 18 Ratios |
| ≥65 years_Agriflu | Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H3N2(688, 686, 710, 704) | 9.65 Ratios |
| ≥65 years_Agriflu | Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H1N1(687, 686, 710, 705) | 15 Ratios |
| ≥65 years_Agriflu | Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | B(688, 686, 711, 704) | 3.1 Ratios |
| ≥65 years_Fluvirin | Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H1N1(687, 686, 710, 705) | 27 Ratios |
| ≥65 years_Fluvirin | Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | B(688, 686, 711, 704) | 3 Ratios |
| ≥65 years_Fluvirin | Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine | A/H3N2(688, 686, 710, 704) | 16 Ratios |
Secondary
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIV and control.
Time frame: Day 1 to 7 postvaccination
Population: Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Fever(>=38°C)[1422,1428] | 20 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Pain(1412, 1424) | 264 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Ecchymosis Type I(1419, 1425) | 26 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Ecchymosis Type II(1419, 1425) | 7 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Erythema Type I(1410, 1427) | 91 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Erythema Type II(1410, 1427) | 16 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Induration Type I(1423, 1429) | 78 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Induration Type II(1423, 1429) | 25 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Swelling Type I(1419, 1427) | 50 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Swelling Type II(1419, 1427) | 21 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Chills(1403,1407) | 64 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Malaise(1402,1405) | 88 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Nausea(1401,1405) | 48 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Myalgia(1400,1403) | 128 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Arthralgia(1396,1403) | 83 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Headache(1397,1403) | 153 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Sweating(1403,1405) | 99 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Fatigue(1404,1407) | 143 Subjects |
| Agriflu | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Loss of Appetite(1404,1403) | 43 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Fatigue(1404,1407) | 145 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Chills(1403,1407) | 68 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Pain(1412, 1424) | 254 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Headache(1397,1403) | 161 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Ecchymosis Type I(1419, 1425) | 33 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Malaise(1402,1405) | 95 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Ecchymosis Type II(1419, 1425) | 11 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Fever(>=38°C)[1422,1428] | 21 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Erythema Type I(1410, 1427) | 93 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Nausea(1401,1405) | 44 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Erythema Type II(1410, 1427) | 10 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Sweating(1403,1405) | 102 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Induration Type I(1423, 1429) | 65 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Myalgia(1400,1403) | 140 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Induration Type II(1423, 1429) | 19 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Loss of Appetite(1404,1403) | 59 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Swelling Type I(1419, 1427) | 44 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Arthralgia(1396,1403) | 87 Subjects |
| Fluvirin | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf | Swelling Type II(1419, 1427) | 15 Subjects |