Influenza
Conditions
Keywords
Swine Flu, Flu, Vaccine, Adults, Elderly, Non-Elderly, Adjuvant
Brief summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
Interventions
BIOLOGICALMF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Sponsors
Novartis Vaccines
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion criteria
* History of serious disease. * History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. * Known or suspected impairment/alteration of immune function. * Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination. * Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study. * For additional entry criteria, please refer to protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | 21 days after each vaccination | Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40. |
| Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | 21 days after each vaccination | Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | 21 days after each vaccination | Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40. |
| Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | 21 days after vaccination | Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers. |
| Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | 7 days after vaccination | Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity. |
| Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | 21 days after each vaccination | Geometric mean hemagglutinin inhibition (HI) titer = GMT |
| Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | 7 days after vaccination | Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity. |
| Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | 7 days after vaccination | Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity. |
| Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | 7 days after vaccination | Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity. |
| Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | 21 days after each vaccination | Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40. |
Countries
Mexico, United States
Participant flow
Recruitment details
Participants were enrolled at 21 sites in the US.
Participants by arm
| Arm | Count |
|---|---|
| 3.75_(50)MF59 (18 to 64) 50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects 18 to 64 years of age | 155 |
| 7.5 w/o MF59 (18 to 64) 1 dose of 7.5 µg A/H1N1 in subjects 18 to 64 years of age | 153 |
| 7.5_(50)MF59 (18 to 64) 50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age | 157 |
| 7.5_(100)MF59 (18 to 64) 100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age | 153 |
| 15 w/o MF59 (18 to 64) 1 dose of 15 µg A/H1N1 in subjects 18 to 64 years of age | 155 |
| 15_(50)MF59 (18 to 64) 50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects 18 to 64 years of age | 154 |
| 15_(100)MF59 (18 to 64) 100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen | 159 |
| 30 w/o MF59 (18 to 64) 1 dose of 30 µg A/H1N1 in subjects 18 to 64 years of age | 154 |
| 3.75_(50)MF59 (≥ 65 ) 50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects ≥ 65 years of age | 170 |
| 7.5 w/o MF59 (≥ 65) 1 dose of 7.5 µg A/H1N1 in subjects ≥ 65 years of age | 168 |
| 7.5_(50)MF59 (≥ 65) 50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age | 172 |
| 7.5_(100)MF59 (≥ 65) 100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age | 168 |
| 15 w/o MF59 (≥ 65) 1 dose of 15 µg A/H1N1 in subjects ≥ 65 years of age | 168 |
| 15_(50)MF59 (≥ 65) 50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age | 171 |
| 15_(100)MF59 (≥ 65) 100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age | 169 |
| 30 w/o MF59 (≥ 65) 1 dose of 30 µg A/H1N1 in subjects ≥ 65 years of age | 166 |
| Total | 2,592 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Inappropriate enrolment | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 1 | 2 | 2 | 1 | 3 | 0 | 1 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Unable to classify | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 2 | 3 | 2 | 0 | 2 | 2 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 3.75_(50)MF59 (18 to 64) | 7.5 w/o MF59 (18 to 64) | 7.5_(50)MF59 (18 to 64) | 7.5_(100)MF59 (18 to 64) | 15 w/o MF59 (18 to 64) | 15_(50)MF59 (18 to 64) | 15_(100)MF59 (18 to 64) | 30 w/o MF59 (18 to 64) | 3.75_(50)MF59 (≥ 65 ) | 7.5 w/o MF59 (≥ 65) | 7.5_(50)MF59 (≥ 65) | 7.5_(100)MF59 (≥ 65) | 15 w/o MF59 (≥ 65) | 15_(50)MF59 (≥ 65) | 15_(100)MF59 (≥ 65) | 30 w/o MF59 (≥ 65) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 40.3 years STANDARD_DEVIATION 12.8 | 39.8 years STANDARD_DEVIATION 12.9 | 39.1 years STANDARD_DEVIATION 13.5 | 40.6 years STANDARD_DEVIATION 12.2 | 41.8 years STANDARD_DEVIATION 12.9 | 39.7 years STANDARD_DEVIATION 13.1 | 38.8 years STANDARD_DEVIATION 11.9 | 40.8 years STANDARD_DEVIATION 13 | 70.8 years STANDARD_DEVIATION 5.1 | 71.8 years STANDARD_DEVIATION 5.6 | 71.4 years STANDARD_DEVIATION 5.6 | 70.7 years STANDARD_DEVIATION 5.1 | 71.0 years STANDARD_DEVIATION 5 | 70.4 years STANDARD_DEVIATION 4.9 | 71.3 years STANDARD_DEVIATION 5.2 | 70.8 years STANDARD_DEVIATION 5.3 | 39.6 years STANDARD_DEVIATION 12.8 |
| Sex/Gender, Customized Female(18 to 64 or ≥65 yrs) | 94 participants | 91 participants | 100 participants | 94 participants | 98 participants | 85 participants | 88 participants | 91 participants | 116 participants | 80 participants | 101 participants | 98 participants | 100 participants | 97 participants | 90 participants | 90 participants | 1513 participants |
| Sex/Gender, Customized Male(18 to 64 or ≥65 years) | 61 participants | 62 participants | 57 participants | 59 participants | 57 participants | 69 participants | 71 participants | 63 participants | 54 participants | 88 participants | 71 participants | 70 participants | 68 participants | 74 participants | 79 participants | 76 participants | 1079 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 125 / 170 | 108 / 168 | 121 / 171 | 128 / 165 | 113 / 170 | 122 / 169 | 130 / 174 | 110 / 168 | 102 / 170 | 88 / 166 | 101 / 173 | 118 / 169 | 104 / 169 | 109 / 171 | 97 / 169 | 99 / 167 |
| serious Total, serious adverse events | 5 / 170 | 5 / 168 | 5 / 171 | 5 / 165 | 6 / 170 | 6 / 169 | 5 / 174 | 7 / 168 | 9 / 170 | 16 / 166 | 18 / 173 | 11 / 169 | 12 / 169 | 20 / 171 | 14 / 169 | 10 / 167 |
Outcome results
Primary
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
Time frame: 21 days after each vaccination
Population: The analysis was based on the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 43 | 138 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 22 | 113 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 22 | 129 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 43 | 118 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 202 (N=79,65,78,80,73,74,74,76) | 68 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 202 (N=79,65,78,80,73,74,74,76) | 50 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 387(N=105,95,88,84,91,91,106,84 | 76 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day387(N=105,95,88,84,91,91,106,84) | 52 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 202 (N=79,65,78,80,73,74,74,76) | 51 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 43 | 133 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 202 (N=79,65,78,80,73,74,74,76) | 32 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 387(N=105,95,88,84,91,91,106,84 | 78 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 22 | 126 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 43 | 104 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 22 | 100 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day387(N=105,95,88,84,91,91,106,84) | 48 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 387(N=105,95,88,84,91,91,106,84 | 66 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 202 (N=79,65,78,80,73,74,74,76) | 67 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day387(N=105,95,88,84,91,91,106,84) | 50 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 43 | 136 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 202 (N=79,65,78,80,73,74,74,76) | 48 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 43 | 123 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 22 | 135 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 22 | 123 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day387(N=105,95,88,84,91,91,106,84) | 53 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 22 | 126 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 22 | 134 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 43 | 129 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 43 | 137 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 202 (N=79,65,78,80,73,74,74,76) | 70 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 202 (N=79,65,78,80,73,74,74,76) | 53 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 387(N=105,95,88,84,91,91,106,84 | 67 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 43 | 126 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 387(N=105,95,88,84,91,91,106,84 | 66 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 43 | 135 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 22 | 133 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day387(N=105,95,88,84,91,91,106,84) | 58 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 202 (N=79,65,78,80,73,74,74,76) | 56 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 202 (N=79,65,78,80,73,74,74,76) | 49 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 22 | 127 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day387(N=105,95,88,84,91,91,106,84) | 62 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 22 | 124 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 43 | 137 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 22 | 135 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 387(N=105,95,88,84,91,91,106,84 | 74 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 202 (N=79,65,78,80,73,74,74,76) | 49 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 202 (N=79,65,78,80,73,74,74,76) | 59 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 43 | 125 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 43 | 145 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 22 | 135 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 43 | 139 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 202 (N=79,65,78,80,73,74,74,76) | 65 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 202 (N=79,65,78,80,73,74,74,76) | 51 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day387(N=105,95,88,84,91,91,106,84) | 71 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 387(N=105,95,88,84,91,91,106,84 | 89 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 22 | 147 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day387(N=105,95,88,84,91,91,106,84) | 54 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 202 (N=79,65,78,80,73,74,74,76) | 55 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 202 (N=79,65,78,80,73,74,74,76) | 69 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 43 | 132 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 43 | 142 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion Day 22 | 130 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 22 | 141 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroprotection Day 387(N=105,95,88,84,91,91,106,84 | 69 Participants |
Primary
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
Time frame: 21 days after each vaccination
Population: The analysis was on the per protocol set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 43 | 131 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 22 | 89 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 22 | 122 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 43 | 90 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 202 (N=80,71,85,79,84,82,87,82) | 54 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 202 (N=80,71,85,79,84,82,87,82) | 31 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 387(N=84,87,98,86,106,93,89,99) | 50 Participants |
| 3.75_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 387(N=84,87,98,86,106,93,89,99) | 30 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 202 (N=80,71,85,79,84,82,87,82) | 41 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 43 | 116 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 202 (N=80,71,85,79,84,82,87,82) | 16 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 387(N=84,87,98,86,106,93,89,99) | 56 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 22 | 119 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 43 | 75 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 22 | 76 Participants |
| 7.5 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 387(N=84,87,98,86,106,93,89,99) | 25 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 387(N=84,87,98,86,106,93,89,99) | 55 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 202 (N=80,71,85,79,84,82,87,82) | 45 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 387(N=84,87,98,86,106,93,89,99) | 26 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 43 | 132 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 202 (N=80,71,85,79,84,82,87,82) | 30 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 43 | 103 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 22 | 126 Participants |
| 7.5_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 22 | 102 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 387(N=84,87,98,86,106,93,89,99) | 33 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 22 | 92 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 22 | 122 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 43 | 95 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 43 | 131 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 202 (N=80,71,85,79,84,82,87,82) | 52 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 202 (N=80,71,85,79,84,82,87,82) | 31 Participants |
| 7.5_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 387(N=84,87,98,86,106,93,89,99) | 57 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 43 | 94 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 387(N=84,87,98,86,106,93,89,99) | 67 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 43 | 126 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 22 | 136 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 387(N=84,87,98,86,106,93,89,99) | 37 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 202 (N=80,71,85,79,84,82,87,82) | 55 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 202 (N=80,71,85,79,84,82,87,82) | 35 Participants |
| 15 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 22 | 104 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 387(N=84,87,98,86,106,93,89,99) | 30 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 22 | 110 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 43 | 136 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 22 | 141 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 387(N=84,87,98,86,106,93,89,99) | 55 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 202 (N=80,71,85,79,84,82,87,82) | 27 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 202 (N=80,71,85,79,84,82,87,82) | 45 Participants |
| 15_(50)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 43 | 106 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 43 | 143 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 22 | 111 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 43 | 113 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 202 (N=80,71,85,79,84,82,87,82) | 63 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 202 (N=80,71,85,79,84,82,87,82) | 38 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 387(N=84,87,98,86,106,93,89,99) | 47 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 387(N=84,87,98,86,106,93,89,99) | 65 Participants |
| 15_(100)MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 22 | 142 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 387(N=84,87,98,86,106,93,89,99) | 32 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 202 (N=80,71,85,79,84,82,87,82) | 36 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 202 (N=80,71,85,79,84,82,87,82) | 57 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 43 | 103 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 43 | 136 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion Day 22 | 108 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 22 | 135 Participants |
| 30 w/o MF59 | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroprotection Day 387(N=84,87,98,86,106,93,89,99) | 69 Participants |
Secondary
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Geometric mean hemagglutinin inhibition (HI) titer = GMT
Time frame: 21 days after each vaccination
Population: The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CBER criteria, 18 to 64 years and over 64 years of age.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 3.75_(50)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22(18-64yrs;N=146,142,142,141,141,138,149,144) | 299 Geometric Mean Titer |
| 3.75_(50)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43(18-64yrs;N=146,142,142,141,141,138,149,144) | 327 Geometric Mean Titer |
| 3.75_(50)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 138 Geometric Mean Titer |
| 3.75_(50)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 135 Geometric Mean Titer |
| 7.5 w/o MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 118 Geometric Mean Titer |
| 7.5 w/o MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43(18-64yrs;N=146,142,142,141,141,138,149,144) | 239 Geometric Mean Titer |
| 7.5 w/o MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22(18-64yrs;N=146,142,142,141,141,138,149,144) | 238 Geometric Mean Titer |
| 7.5 w/o MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 133 Geometric Mean Titer |
| 7.5_(50)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22(18-64yrs;N=146,142,142,141,141,138,149,144) | 379 Geometric Mean Titer |
| 7.5_(50)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 131 Geometric Mean Titer |
| 7.5_(50)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43(18-64yrs;N=146,142,142,141,141,138,149,144) | 359 Geometric Mean Titer |
| 7.5_(50)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 146 Geometric Mean Titer |
| 7.5_(100)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22(18-64yrs;N=146,142,142,141,141,138,149,144) | 551 Geometric Mean Titer |
| 7.5_(100)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43(18-64yrs;N=146,142,142,141,141,138,149,144) | 538 Geometric Mean Titer |
| 7.5_(100)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 184 Geometric Mean Titer |
| 7.5_(100)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 167 Geometric Mean Titer |
| 15 w/o MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 151 Geometric Mean Titer |
| 15 w/o MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 187 Geometric Mean Titer |
| 15 w/o MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43(18-64yrs;N=146,142,142,141,141,138,149,144) | 412 Geometric Mean Titer |
| 15 w/o MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22(18-64yrs;N=146,142,142,141,141,138,149,144) | 536 Geometric Mean Titer |
| 15_(50)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 164 Geometric Mean Titer |
| 15_(50)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 203 Geometric Mean Titer |
| 15_(50)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43(18-64yrs;N=146,142,142,141,141,138,149,144) | 494 Geometric Mean Titer |
| 15_(50)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22(18-64yrs;N=146,142,142,141,141,138,149,144) | 538 Geometric Mean Titer |
| 15_(100)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 240 Geometric Mean Titer |
| 15_(100)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22(18-64yrs;N=146,142,142,141,141,138,149,144) | 677 Geometric Mean Titer |
| 15_(100)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 252 Geometric Mean Titer |
| 15_(100)MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43(18-64yrs;N=146,142,142,141,141,138,149,144) | 618 Geometric Mean Titer |
| 30 w/o MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43(18-64yrs;N=146,142,142,141,141,138,149,144) | 497 Geometric Mean Titer |
| 30 w/o MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 237 Geometric Mean Titer |
| 30 w/o MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 43 (≥65 yrs;N=150,147,164,148,159,155,154,150) | 211 Geometric Mean Titer |
| 30 w/o MF59 | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Day 22(18-64yrs;N=146,142,142,141,141,138,149,144) | 637 Geometric Mean Titer |
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.998, 1.603]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.791, 1.262]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.558, 0.897]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint95% CI: [0.681, 1.089]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint95% CI: [0.596, 0.956]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.434, 0.693]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.51, 0.817]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.625, 1]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.441, 0.71]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.538, 0.862]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.47, 0.757]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.342, 0.549]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.403, 0.647]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.56, 0.896]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.683, 1.088]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint95% CI: [0.597, 0.954]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint95% CI: [0.435, 0.692]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint95% CI: [0.511, 0.817]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint95% CI: [0.961, 1.541]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint95% CI: [0.841, 1.352]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint95% CI: [0.612, 0.981]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.719, 1.157]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint95% CI: [0.692, 1.109]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.504, 0.804]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.593, 0.949]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint95% CI: [0.574, 0.919]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint95% CI: [0.675, 1.084]
Comparison: Two-sided 95% CI around the point estimates were to be presented for each endpoint.95% CI: [0.931, 1.489]
Secondary
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.
Time frame: 21 days after vaccination
Population: The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CHMP criteria, 18 to 60 years and over 60 years of age.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 3.75_(50)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (18-60y; N=135,130,132,132,122,124,141,127) | 19 Geometric Mean Ratio |
| 3.75_(50)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (18-60y; N=135,130,132,132,122,124,141,127) | 20 Geometric Mean Ratio |
| 3.75_(50)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (≥61yrs; N=161,159,174,157,178,169,162,167) | 6.11 Geometric Mean Ratio |
| 3.75_(50)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (≥61 yrs;N=161,159,174,157,178,169,162,167) | 6.2 Geometric Mean Ratio |
| 7.5 w/o MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (≥61 yrs;N=161,159,174,157,178,169,162,167) | 4.18 Geometric Mean Ratio |
| 7.5 w/o MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (18-60y; N=135,130,132,132,122,124,141,127) | 15 Geometric Mean Ratio |
| 7.5 w/o MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (18-60y; N=135,130,132,132,122,124,141,127) | 15 Geometric Mean Ratio |
| 7.5 w/o MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (≥61yrs; N=161,159,174,157,178,169,162,167) | 4.65 Geometric Mean Ratio |
| 7.5_(50)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (18-60y; N=135,130,132,132,122,124,141,127) | 23 Geometric Mean Ratio |
| 7.5_(50)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (≥61 yrs;N=161,159,174,157,178,169,162,167) | 6.77 Geometric Mean Ratio |
| 7.5_(50)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (18-60y; N=135,130,132,132,122,124,141,127) | 22 Geometric Mean Ratio |
| 7.5_(50)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (≥61yrs; N=161,159,174,157,178,169,162,167) | 7.46 Geometric Mean Ratio |
| 7.5_(100)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (18-60y; N=135,130,132,132,122,124,141,127) | 33 Geometric Mean Ratio |
| 7.5_(100)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (18-60y; N=135,130,132,132,122,124,141,127) | 33 Geometric Mean Ratio |
| 7.5_(100)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (≥61yrs; N=161,159,174,157,178,169,162,167) | 8.63 Geometric Mean Ratio |
| 7.5_(100)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (≥61 yrs;N=161,159,174,157,178,169,162,167) | 7.78 Geometric Mean Ratio |
| 15 w/o MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (≥61 yrs;N=161,159,174,157,178,169,162,167) | 6.72 Geometric Mean Ratio |
| 15 w/o MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (≥61yrs; N=161,159,174,157,178,169,162,167) | 8.37 Geometric Mean Ratio |
| 15 w/o MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (18-60y; N=135,130,132,132,122,124,141,127) | 31 Geometric Mean Ratio |
| 15 w/o MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (18-60y; N=135,130,132,132,122,124,141,127) | 40 Geometric Mean Ratio |
| 15_(50)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (≥61 yrs;N=161,159,174,157,178,169,162,167) | 7.78 Geometric Mean Ratio |
| 15_(50)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (≥61yrs; N=161,159,174,157,178,169,162,167) | 9.6 Geometric Mean Ratio |
| 15_(50)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (18-60y; N=135,130,132,132,122,124,141,127) | 33 Geometric Mean Ratio |
| 15_(50)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (18-60y; N=135,130,132,132,122,124,141,127) | 36 Geometric Mean Ratio |
| 15_(100)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (≥61 yrs;N=161,159,174,157,178,169,162,167) | 11 Geometric Mean Ratio |
| 15_(100)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (18-60y; N=135,130,132,132,122,124,141,127) | 44 Geometric Mean Ratio |
| 15_(100)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (≥61yrs; N=161,159,174,157,178,169,162,167) | 11 Geometric Mean Ratio |
| 15_(100)MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (18-60y; N=135,130,132,132,122,124,141,127) | 40 Geometric Mean Ratio |
| 30 w/o MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (18-60y; N=135,130,132,132,122,124,141,127) | 37 Geometric Mean Ratio |
| 30 w/o MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (≥61yrs; N=161,159,174,157,178,169,162,167) | 10 Geometric Mean Ratio |
| 30 w/o MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 43 (≥61 yrs;N=161,159,174,157,178,169,162,167) | 8.8 Geometric Mean Ratio |
| 30 w/o MF59 | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Day 22 (18-60y; N=135,130,132,132,122,124,141,127) | 47 Geometric Mean Ratio |
Secondary
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Time frame: 7 days after vaccination
Population: The population used in analysis was the safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Fatigue | 25 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Swelling | 9 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea | 11 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Induration | 11 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Headache | 37 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Erythema | 2 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Myalgia | 29 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Oral Temp. (≥40°C) | 0 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Chills | 6 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=169, 168, 169, 165, 170, 168, 173,168) | 3 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Stay Home | 6 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Arthralgia | 14 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Pain | 67 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Tenderness | 63 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Nausea | 14 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Swelling | 6 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Nausea | 15 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Myalgia | 22 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Stay Home | 6 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=169, 168, 169, 165, 170, 168, 173,168) | 3 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Arthralgia | 13 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Headache | 39 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Oral Temp. (≥40°C) | 0 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Induration | 5 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Pain | 38 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Fatigue | 28 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Tenderness | 44 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Erythema | 2 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea | 7 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Chills | 9 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=169, 168, 169, 165, 170, 168, 173,168) | 2 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Oral Temp. (≥40°C) | 0 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Arthralgia | 17 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Stay Home | 4 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Tenderness | 59 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Pain | 51 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Chills | 11 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Myalgia | 28 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Headache | 42 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Swelling | 4 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea | 19 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Induration | 9 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Nausea | 19 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Erythema | 2 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Fatigue | 27 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea | 5 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Headache | 32 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Erythema | 4 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Oral Temp. (≥40°C) | 0 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Swelling | 6 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Pain | 78 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Fatigue | 17 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Induration | 9 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Tenderness | 79 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Stay Home | 3 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Chills | 8 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=169, 168, 169, 165, 170, 168, 173,168) | 1 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Myalgia | 29 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Nausea | 8 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Arthralgia | 10 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Arthralgia | 11 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Pain | 27 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Erythema | 3 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Swelling | 4 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Induration | 8 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Tenderness | 42 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Chills | 9 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Myalgia | 21 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Headache | 43 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Nausea | 12 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=169, 168, 169, 165, 170, 168, 173,168) | 3 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea | 11 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Fatigue | 27 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Oral Temp. (≥40°C) | 0 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Stay Home | 8 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Myalgia | 30 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Tenderness | 64 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Swelling | 3 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea | 15 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Headache | 39 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Fatigue | 27 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Stay Home | 9 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Arthralgia | 10 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Induration | 8 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Pain | 57 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=169, 168, 169, 165, 170, 168, 173,168) | 2 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Nausea | 13 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Erythema | 2 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Chills | 8 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Oral Temp. (≥40°C) | 0 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Fatigue | 26 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Pain | 78 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Nausea | 16 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Myalgia | 37 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Chills | 14 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=169, 168, 169, 165, 170, 168, 173,168) | 1 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Tenderness | 89 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea | 6 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Induration | 15 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Swelling | 13 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Erythema | 4 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Stay Home | 9 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Oral Temp. (≥40°C) | 0 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Headache | 36 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Arthralgia | 6 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Stay Home | 6 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Erythema | 0 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Nausea | 13 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Headache | 36 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Tenderness | 51 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Arthralgia | 7 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Oral Temp. (≥40°C) | 0 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=169, 168, 169, 165, 170, 168, 173,168) | 2 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Pain | 44 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Swelling | 3 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Induration | 7 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea | 7 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Myalgia | 24 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Fatigue | 27 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Chills | 10 Participants |
Secondary
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Time frame: 7 days after vaccination
Population: The analysis was on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Myalgia | 20 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Swelling | 1 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Pain | 18 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Vomitting (N=170,166,173,169.169,170,169,167) | 0 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Arthralgia | 13 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Diarrhoea | 5 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Stay Home | 8 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Induration | 8 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=170,166,172,169.167,171,169,166) | 9 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Headache | 23 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Erythema | 1 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Nausea | 2 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Fatigue | 23 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Tenderness | 27 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Chills | 6 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Swelling | 6 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Myalgia | 14 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Arthralgia | 9 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=170,166,172,169.167,171,169,166) | 7 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Fatigue | 20 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Diarrhoea | 10 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Pain | 8 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Stay Home | 3 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Induration | 8 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Vomitting (N=170,166,173,169.169,170,169,167) | 2 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Erythema | 1 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Tenderness | 10 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Nausea | 4 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Chills | 8 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Headache | 21 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Oral Temp ≥40°C | 1 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Diarrhoea | 14 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Chills | 5 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Tenderness | 23 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Fatigue | 21 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Nausea | 2 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Headache | 22 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Stay Home | 8 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Pain | 22 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Vomitting (N=170,166,173,169.169,170,169,167) | 0 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=170,166,172,169.167,171,169,166) | 7 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Induration | 5 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Erythema | 1 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Arthralgia | 13 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Swelling | 2 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Myalgia | 19 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Induration | 10 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Stay Home | 3 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=170,166,172,169.167,171,169,166) | 11 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Swelling | 14 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Pain | 30 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Tenderness | 42 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Chills | 4 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Myalgia | 21 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Arthralgia | 12 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Headache | 25 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Nausea | 3 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Vomitting (N=170,166,173,169.169,170,169,167) | 0 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Diarrhoea | 9 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Erythema | 2 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Fatigue | 19 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Arthralgia | 11 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Induration | 2 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Diarrhoea | 9 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Stay Home | 2 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Vomitting (N=170,166,173,169.169,170,169,167) | 0 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Myalgia | 17 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Swelling | 1 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Pain | 15 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Fatigue | 20 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Chills | 6 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Tenderness | 24 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Erythema | 3 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Nausea | 6 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Headache | 16 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=170,166,172,169.167,171,169,166) | 7 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Stay Home | 4 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Chills | 1 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Headache | 22 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Tenderness | 28 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Pain | 27 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Nausea | 5 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Induration | 6 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Vomitting (N=170,166,173,169.169,170,169,167) | 1 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Swelling | 1 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Diarrhoea | 12 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=170,166,172,169.167,171,169,166) | 6 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Erythema | 2 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Fatigue | 15 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Myalgia | 15 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Arthralgia | 10 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Induration | 7 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Arthralgia | 11 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Nausea | 6 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Headache | 17 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Stay Home | 5 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Tenderness | 39 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Chills | 5 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Fatigue | 22 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Pain | 16 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Vomitting (N=170,166,173,169.169,170,169,167) | 0 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Erythema | 3 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=170,166,172,169.167,171,169,166) | 5 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Swelling | 1 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Myalgia | 21 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Diarrhoea | 9 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Nausea | 7 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Pain | 19 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Erythema | 5 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Swelling | 10 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Induration | 14 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Tenderness | 32 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Chills | 3 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Myalgia | 14 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Arthralgia | 10 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Headache | 14 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Vomitting (N=170,166,173,169.169,170,169,167) | 0 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Diarrhoea | 6 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Fatigue | 13 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Stay Home | 4 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=170,166,172,169.167,171,169,166) | 2 Participants |
Secondary
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Time frame: 7 days after vaccination
Population: The analysis was on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Tenderness (N=164,163,162,160,162,160,169,163) | 51 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Erythema (N=164,163,162,160,162,160,169,163) | 2 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Swelling (N=164,163,162,160,162,160,169,162) | 10 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Induration (N=164,163,162,160,162,160,169,163) | 7 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Pain | 46 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Chills (N=164,163,162,160,162,160,169,163) | 9 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Myalgia (N=164,163,162,160,162,160,169,163) | 22 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Arthralgia (N=164,163,162,160,162,160,169,163) | 7 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Headache(N=164,163,162,160,162,160,169,163) | 28 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Nausea(N=164,163,162,160,162,160,169,163) | 5 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=164,163,162,160,162,160,169,163) | 0 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea(N=164,163,162,160,162,160,169,163) | 5 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Fatigue(N=164,163,162,160,162,160,169,163) | 17 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Stay Home (N=164,163,161,160,162,159,169,163) | 4 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Analg/antipyr (N=164,163,162,160,162,160,169,163) | 11 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Headache(N=164,163,162,160,162,160,169,163) | 17 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Tenderness (N=164,163,162,160,162,160,169,163) | 33 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Induration (N=164,163,162,160,162,160,169,163) | 5 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Myalgia (N=164,163,162,160,162,160,169,163) | 18 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Fatigue(N=164,163,162,160,162,160,169,163) | 12 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Swelling (N=164,163,162,160,162,160,169,162) | 2 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea(N=164,163,162,160,162,160,169,163) | 11 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Pain | 32 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=164,163,162,160,162,160,169,163) | 1 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Chills (N=164,163,162,160,162,160,169,163) | 3 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Arthralgia (N=164,163,162,160,162,160,169,163) | 4 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Erythema (N=164,163,162,160,162,160,169,163) | 1 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Stay Home (N=164,163,161,160,162,159,169,163) | 3 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Nausea(N=164,163,162,160,162,160,169,163) | 7 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Analg/antipyr (N=164,163,162,160,162,160,169,163) | 6 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Fatigue(N=164,163,162,160,162,160,169,163) | 15 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Myalgia (N=164,163,162,160,162,160,169,163) | 14 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Arthralgia (N=164,163,162,160,162,160,169,163) | 7 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Pain | 39 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Swelling (N=164,163,162,160,162,160,169,162) | 5 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Induration (N=164,163,162,160,162,160,169,163) | 6 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Stay Home (N=164,163,161,160,162,159,169,163) | 5 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Headache(N=164,163,162,160,162,160,169,163) | 26 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Tenderness (N=164,163,162,160,162,160,169,163) | 52 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Erythema (N=164,163,162,160,162,160,169,163) | 3 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea(N=164,163,162,160,162,160,169,163) | 8 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=164,163,162,160,162,160,169,163) | 1 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Chills (N=164,163,162,160,162,160,169,163) | 4 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Analg/antipyr (N=164,163,162,160,162,160,169,163) | 7 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Nausea(N=164,163,162,160,162,160,169,163) | 9 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Fatigue(N=164,163,162,160,162,160,169,163) | 18 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Swelling (N=164,163,162,160,162,160,169,162) | 8 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Stay Home (N=164,163,161,160,162,159,169,163) | 0 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Induration (N=164,163,162,160,162,160,169,163) | 7 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Tenderness (N=164,163,162,160,162,160,169,163) | 56 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Chills (N=164,163,162,160,162,160,169,163) | 5 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Myalgia (N=164,163,162,160,162,160,169,163) | 20 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Arthralgia (N=164,163,162,160,162,160,169,163) | 7 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Headache(N=164,163,162,160,162,160,169,163) | 23 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Nausea(N=164,163,162,160,162,160,169,163) | 8 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=164,163,162,160,162,160,169,163) | 0 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Analg/antipyr (N=164,163,162,160,162,160,169,163) | 5 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea(N=164,163,162,160,162,160,169,163) | 5 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Pain | 42 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Erythema (N=164,163,162,160,162,160,169,163) | 1 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Myalgia (N=164,163,162,160,162,160,169,163) | 20 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Tenderness (N=164,163,162,160,162,160,169,163) | 44 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Stay Home (N=164,163,161,160,162,159,169,163) | 2 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Pain | 35 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Fatigue(N=164,163,162,160,162,160,169,163) | 12 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Arthralgia (N=164,163,162,160,162,160,169,163) | 6 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Chills (N=164,163,162,160,162,160,169,163) | 5 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Headache(N=164,163,162,160,162,160,169,163) | 25 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Swelling (N=164,163,162,160,162,160,169,162) | 6 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=164,163,162,160,162,160,169,163) | 1 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Nausea(N=164,163,162,160,162,160,169,163) | 4 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Induration (N=164,163,162,160,162,160,169,163) | 5 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Erythema (N=164,163,162,160,162,160,169,163) | 3 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea(N=164,163,162,160,162,160,169,163) | 6 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Analg/antipyr (N=164,163,162,160,162,160,169,163) | 9 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Headache(N=164,163,162,160,162,160,169,163) | 32 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Stay Home (N=164,163,161,160,162,159,169,163) | 3 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Nausea(N=164,163,162,160,162,160,169,163) | 9 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Myalgia (N=164,163,162,160,162,160,169,163) | 16 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Tenderness (N=164,163,162,160,162,160,169,163) | 58 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Fatigue(N=164,163,162,160,162,160,169,163) | 18 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=164,163,162,160,162,160,169,163) | 1 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Arthralgia (N=164,163,162,160,162,160,169,163) | 7 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Analg/antipyr (N=164,163,162,160,162,160,169,163) | 14 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Pain | 43 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Induration (N=164,163,162,160,162,160,169,163) | 11 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Erythema (N=164,163,162,160,162,160,169,163) | 1 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea(N=164,163,162,160,162,160,169,163) | 8 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Swelling (N=164,163,162,160,162,160,169,162) | 4 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Chills (N=164,163,162,160,162,160,169,163) | 7 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Induration (N=164,163,162,160,162,160,169,163) | 13 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Erythema (N=164,163,162,160,162,160,169,163) | 4 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Pain | 54 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Myalgia (N=164,163,162,160,162,160,169,163) | 24 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Nausea(N=164,163,162,160,162,160,169,163) | 13 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Arthralgia (N=164,163,162,160,162,160,169,163) | 14 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Swelling (N=164,163,162,160,162,160,169,162) | 9 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=164,163,162,160,162,160,169,163) | 2 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Headache(N=164,163,162,160,162,160,169,163) | 26 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Tenderness (N=164,163,162,160,162,160,169,163) | 66 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea(N=164,163,162,160,162,160,169,163) | 7 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Stay Home (N=164,163,161,160,162,159,169,163) | 6 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Fatigue(N=164,163,162,160,162,160,169,163) | 26 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Chills (N=164,163,162,160,162,160,169,163) | 5 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Analg/antipyr (N=164,163,162,160,162,160,169,163) | 10 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Arthralgia (N=164,163,162,160,162,160,169,163) | 3 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Headache(N=164,163,162,160,162,160,169,163) | 17 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Chills (N=164,163,162,160,162,160,169,163) | 2 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Nausea(N=164,163,162,160,162,160,169,163) | 6 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Tenderness (N=164,163,162,160,162,160,169,163) | 56 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Vomiting (N=164,163,162,160,162,160,169,163) | 0 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Erythema (N=164,163,162,160,162,160,169,163) | 1 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Diarrhoea(N=164,163,162,160,162,160,169,163) | 5 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Induration (N=164,163,162,160,162,160,169,163) | 11 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Fatigue(N=164,163,162,160,162,160,169,163) | 10 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Oral Temp ≥40°C | 0 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Swelling (N=164,163,162,160,162,160,169,162) | 2 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Myalgia (N=164,163,162,160,162,160,169,163) | 10 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Stay Home (N=164,163,161,160,162,159,169,163) | 0 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Pain | 45 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Analg/antipyr (N=164,163,162,160,162,160,169,163) | 9 Participants |
Secondary
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Time frame: 7 days after vaccination
Population: The analysis was on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Tenderness (N=164,156,171,160,166,168,165,164) | 22 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Chills (N=163,156,171,160,166,168,165,164) | 2 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Myalgia (N=163,156,171,160,166,168,165,164) | 20 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Arthralgia (N=163,156,171,160,166,168,165,164) | 15 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Headache (N=163,156,171,160,166,168,165,164) | 14 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Nausea (N=163,156,171,160,166,168,165,164) | 4 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Vomiting (N=164,156,171,160,166,168,165,165) | 0 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Diarrhoea (N=163,156,171,160,166,168,165,164) | 4 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Fatigue (N=163,156,171,160,166,168,165,164) | 19 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Oral Temp≥40°C (N=164,156,171,160,166,168,165,165) | 0 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Stay Home(N=163,156,171,159,166,168,165,164) | 3 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=164,156,171,160,166,167,165,163) | 2 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Pain (N=164,156,171,160,166,168,165,165) | 12 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Erythema (N=163,156,171,160,166,168,165,164) | 1 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Swelling (N=163,156,171,160,166,168,165,164) | 1 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Induration (N=163,156,171,160,166,168,165,164) | 3 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Tenderness (N=164,156,171,160,166,168,165,164) | 12 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Headache (N=163,156,171,160,166,168,165,164) | 13 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Induration (N=163,156,171,160,166,168,165,164) | 3 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Nausea (N=163,156,171,160,166,168,165,164) | 5 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Myalgia (N=163,156,171,160,166,168,165,164) | 14 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Swelling (N=163,156,171,160,166,168,165,164) | 1 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Erythema (N=163,156,171,160,166,168,165,164) | 0 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Fatigue (N=163,156,171,160,166,168,165,164) | 9 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Stay Home(N=163,156,171,159,166,168,165,164) | 5 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Oral Temp≥40°C (N=164,156,171,160,166,168,165,165) | 0 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Arthralgia (N=163,156,171,160,166,168,165,164) | 8 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=164,156,171,160,166,167,165,163) | 7 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Vomiting (N=164,156,171,160,166,168,165,165) | 1 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Diarrhoea (N=163,156,171,160,166,168,165,164) | 5 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Pain (N=164,156,171,160,166,168,165,165) | 8 Participants |
| 7.5 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Chills (N=163,156,171,160,166,168,165,164) | 7 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Headache (N=163,156,171,160,166,168,165,164) | 17 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Fatigue (N=163,156,171,160,166,168,165,164) | 14 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Oral Temp≥40°C (N=164,156,171,160,166,168,165,165) | 1 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Induration (N=163,156,171,160,166,168,165,164) | 7 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Arthralgia (N=163,156,171,160,166,168,165,164) | 11 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Swelling (N=163,156,171,160,166,168,165,164) | 3 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Tenderness (N=164,156,171,160,166,168,165,164) | 26 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Erythema (N=163,156,171,160,166,168,165,164) | 1 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Nausea (N=163,156,171,160,166,168,165,164) | 5 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Pain (N=164,156,171,160,166,168,165,165) | 17 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Vomiting (N=164,156,171,160,166,168,165,165) | 2 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Chills (N=163,156,171,160,166,168,165,164) | 7 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=164,156,171,160,166,167,165,163) | 10 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Diarrhoea (N=163,156,171,160,166,168,165,164) | 10 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Myalgia (N=163,156,171,160,166,168,165,164) | 15 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Stay Home(N=163,156,171,159,166,168,165,164) | 5 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Tenderness (N=164,156,171,160,166,168,165,164) | 30 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Myalgia (N=163,156,171,160,166,168,165,164) | 9 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Stay Home(N=163,156,171,159,166,168,165,164) | 1 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Vomiting (N=164,156,171,160,166,168,165,165) | 1 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Diarrhoea (N=163,156,171,160,166,168,165,164) | 2 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=164,156,171,160,166,167,165,163) | 4 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Fatigue (N=163,156,171,160,166,168,165,164) | 7 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Arthralgia (N=163,156,171,160,166,168,165,164) | 5 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Erythema (N=163,156,171,160,166,168,165,164) | 5 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Headache (N=163,156,171,160,166,168,165,164) | 12 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Oral Temp≥40°C (N=164,156,171,160,166,168,165,165) | 0 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Nausea (N=163,156,171,160,166,168,165,164) | 3 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Chills (N=163,156,171,160,166,168,165,164) | 4 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Swelling (N=163,156,171,160,166,168,165,164) | 4 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Pain (N=164,156,171,160,166,168,165,165) | 16 Participants |
| 7.5_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Induration (N=163,156,171,160,166,168,165,164) | 4 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Pain (N=164,156,171,160,166,168,165,165) | 17 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Myalgia (N=163,156,171,160,166,168,165,164) | 16 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Swelling (N=163,156,171,160,166,168,165,164) | 1 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Arthralgia (N=163,156,171,160,166,168,165,164) | 9 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Headache (N=163,156,171,160,166,168,165,164) | 15 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Nausea (N=163,156,171,160,166,168,165,164) | 7 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Vomiting (N=164,156,171,160,166,168,165,165) | 1 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=164,156,171,160,166,167,165,163) | 1 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Diarrhoea (N=163,156,171,160,166,168,165,164) | 6 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Fatigue (N=163,156,171,160,166,168,165,164) | 14 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Oral Temp≥40°C (N=164,156,171,160,166,168,165,165) | 0 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Stay Home(N=163,156,171,159,166,168,165,164) | 2 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Induration (N=163,156,171,160,166,168,165,164) | 2 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Erythema (N=163,156,171,160,166,168,165,164) | 3 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Tenderness (N=164,156,171,160,166,168,165,164) | 25 Participants |
| 15 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Chills (N=163,156,171,160,166,168,165,164) | 5 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Erythema (N=163,156,171,160,166,168,165,164) | 1 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Chills (N=163,156,171,160,166,168,165,164) | 3 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Fatigue (N=163,156,171,160,166,168,165,164) | 8 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Nausea (N=163,156,171,160,166,168,165,164) | 4 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Pain (N=164,156,171,160,166,168,165,165) | 15 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Stay Home(N=163,156,171,159,166,168,165,164) | 0 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Oral Temp≥40°C (N=164,156,171,160,166,168,165,165) | 0 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Arthralgia (N=163,156,171,160,166,168,165,164) | 7 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Tenderness (N=164,156,171,160,166,168,165,164) | 26 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Swelling (N=163,156,171,160,166,168,165,164) | 3 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Diarrhoea (N=163,156,171,160,166,168,165,164) | 6 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Vomiting (N=164,156,171,160,166,168,165,165) | 1 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=164,156,171,160,166,167,165,163) | 1 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Myalgia (N=163,156,171,160,166,168,165,164) | 12 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Headache (N=163,156,171,160,166,168,165,164) | 10 Participants |
| 15_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Induration (N=163,156,171,160,166,168,165,164) | 6 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Nausea (N=163,156,171,160,166,168,165,164) | 4 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Diarrhoea (N=163,156,171,160,166,168,165,164) | 6 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Stay Home(N=163,156,171,159,166,168,165,164) | 0 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Vomiting (N=164,156,171,160,166,168,165,165) | 0 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=164,156,171,160,166,167,165,163) | 3 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Pain (N=164,156,171,160,166,168,165,165) | 17 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Induration (N=163,156,171,160,166,168,165,164) | 7 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Swelling (N=163,156,171,160,166,168,165,164) | 6 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Headache (N=163,156,171,160,166,168,165,164) | 11 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Erythema (N=163,156,171,160,166,168,165,164) | 5 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Arthralgia (N=163,156,171,160,166,168,165,164) | 7 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Chills (N=163,156,171,160,166,168,165,164) | 5 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Tenderness (N=164,156,171,160,166,168,165,164) | 31 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Fatigue (N=163,156,171,160,166,168,165,164) | 11 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Myalgia (N=163,156,171,160,166,168,165,164) | 11 Participants |
| 15_(100)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Oral Temp≥40°C (N=164,156,171,160,166,168,165,165) | 0 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Analg/antipyr (N=164,156,171,160,166,167,165,163) | 3 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Vomiting (N=164,156,171,160,166,168,165,165) | 0 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Arthralgia (N=163,156,171,160,166,168,165,164) | 3 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Fatigue (N=163,156,171,160,166,168,165,164) | 5 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Diarrhoea (N=163,156,171,160,166,168,165,164) | 2 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Chills (N=163,156,171,160,166,168,165,164) | 3 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Pain (N=164,156,171,160,166,168,165,165) | 14 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Oral Temp≥40°C (N=164,156,171,160,166,168,165,165) | 0 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Tenderness (N=164,156,171,160,166,168,165,164) | 18 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Headache (N=163,156,171,160,166,168,165,164) | 10 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Stay Home(N=163,156,171,159,166,168,165,164) | 2 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Nausea (N=163,156,171,160,166,168,165,164) | 2 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Swelling (N=163,156,171,160,166,168,165,164) | 3 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Myalgia (N=163,156,171,160,166,168,165,164) | 7 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Erythema (N=163,156,171,160,166,168,165,164) | 2 Participants |
| 30 w/o MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Induration (N=163,156,171,160,166,168,165,164) | 6 Participants |
Secondary
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
Time frame: 21 days after each vaccination
Population: The analysis was on the per protocol set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 22 | 121 Participants |
| 3.75_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 22 | 108 Participants |
| 3.75_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 43 | 128 Participants |
| 3.75_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 43 | 112 Participants |
| 7.5 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 43 | 98 Participants |
| 7.5 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 22 | 95 Participants |
| 7.5 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 22 | 118 Participants |
| 7.5 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 43 | 124 Participants |
| 7.5_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 22 | 126 Participants |
| 7.5_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 43 | 115 Participants |
| 7.5_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 22 | 116 Participants |
| 7.5_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 43 | 126 Participants |
| 7.5_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 22 | 125 Participants |
| 7.5_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 22 | 118 Participants |
| 7.5_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 43 | 128 Participants |
| 7.5_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 43 | 122 Participants |
| 15 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 43 | 110 Participants |
| 15 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 43 | 118 Participants |
| 15 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 22 | 111 Participants |
| 15 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 22 | 116 Participants |
| 15_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 43 | 114 Participants |
| 15_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 43 | 123 Participants |
| 15_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 22 | 113 Participants |
| 15_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 22 | 121 Participants |
| 15_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 43 | 132 Participants |
| 15_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 22 | 140 Participants |
| 15_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 43 | 138 Participants |
| 15_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 22 | 129 Participants |
| 30 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 22 | 116 Participants |
| 30 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 43 | 126 Participants |
| 30 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroconversion Day 43 | 119 Participants |
| 30 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Seroprotection Day 22 | 125 Participants |
Secondary
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
Time frame: 21 days after each vaccination
Population: The analysis was on the per protocol set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 22 | 130 Participants |
| 3.75_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 22 | 94 Participants |
| 3.75_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 43 | 140 Participants |
| 3.75_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 43 | 96 Participants |
| 7.5 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 43 | 81 Participants |
| 7.5 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 22 | 81 Participants |
| 7.5 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 22 | 127 Participants |
| 7.5 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 43 | 125 Participants |
| 7.5_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 22 | 135 Participants |
| 7.5_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 43 | 111 Participants |
| 7.5_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 22 | 109 Participants |
| 7.5_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 43 | 142 Participants |
| 7.5_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 22 | 131 Participants |
| 7.5_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 22 | 100 Participants |
| 7.5_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 43 | 140 Participants |
| 7.5_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 43 | 102 Participants |
| 15 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 43 | 110 Participants |
| 15 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 43 | 143 Participants |
| 15 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 22 | 120 Participants |
| 15 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 22 | 153 Participants |
| 15_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 43 | 117 Participants |
| 15_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 43 | 150 Participants |
| 15_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 22 | 121 Participants |
| 15_(50)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 22 | 155 Participants |
| 15_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 43 | 120 Participants |
| 15_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 22 | 149 Participants |
| 15_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 43 | 150 Participants |
| 15_(100)MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 22 | 117 Participants |
| 30 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 22 | 122 Participants |
| 30 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 43 | 152 Participants |
| 30 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroconversion Day 43 | 116 Participants |
| 30 w/o MF59 | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Seroprotection Day 22 | 151 Participants |