Influenza
Conditions
Keywords
Swine Flu, Flu, Vaccine, Children, Adjuvant
Brief summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
Interventions
BIOLOGICALMF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Children 3 to \< 9 years of age 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. For additional entry criteria, please refer to protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Day 22, Day 29, Day 43, Day 202 and Day 387 | HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for \<65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity. PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively. PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Day 22, Day 29, Day 43 | HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is \> 40%.The percentage of subjects achieving an HI titer ≥ 40 is \> 70% and The GMR is \> 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1-22 and Day1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively. |
| Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1, Day 22, Day 29, Day 43 | Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines Subgroups without recent seasonal flu vaccine: PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively. Subgroups with recent seasonal flu vaccine:PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively. PPS Day 1-29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively |
| Antibody Response Based on Baseline Seropositivity | Day 22, Day 29 and Day 43 | Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline. Subgroups with baseline HI titer \< 1:10: PPS Day 1-29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively. Subgroups with baseline HI titer ≥ 1:10: PPS Day 1-29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively. |
| Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | Day 22, Day 29, Day 43, Day 202 and Day 387 | Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group. PPS Day1-29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively. |
| Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | 7 days after first vaccination | Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1). |
| Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | 7 days after second vaccination | Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1) |
| Number of Participants Reporting Unsolicited Adverse Events (AEs) | Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination | Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1) |
| Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 1, Day 22, Day 29, Day 43 | Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline. Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline \[Day 1 (pre-vaccination)\] as compared to those who are seronegative (HI titer \< 1:10). |
Countries
Mexico, United States
Participant flow
Recruitment details
36 centers in the U.S., of which 34 centers enrolled subjects.
Participants by arm
| Arm | Count |
|---|---|
| 3.75_(50)MF59 50% of MF59 with 3.75 µg A/H1N1 antigen | 173 |
| 7.5 Without MF59 1 dose of 7.5 µg A/H1N1 | 169 |
| 7.5_(50)MF59 50% of MF59 with 7.5 µg A/H1N1 antigen | 169 |
| 7.5_(100)MF59 100% of MF59 with 7.5 µg A/H1N1 antigen | 169 |
| 15 Without MF59 1 dose of 15 µg A/H1N1 | 169 |
| 15_(50)MF59 50% of MF59 with 15 µg A/H1N1 antigen | 169 |
| 15_(100)MF59 100% of MF59 with 15 µg A/H1N1 antigen | 169 |
| 30 Without MF59 1 dose of 30 µg A/H1N1 | 170 |
| Total | 1,357 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Inappropriate enrolment | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Lost to Follow-up | 11 | 9 | 7 | 5 | 11 | 10 | 7 | 7 |
| Overall Study | Unable to classify | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 1 | 3 | 0 | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | 3.75_(50)MF59 | 7.5 Without MF59 | 7.5_(50)MF59 | 7.5_(100)MF59 | 15 Without MF59 | 15_(50)MF59 | 15_(100)MF59 | 30 Without MF59 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 5.6 years STANDARD_DEVIATION 1.7 | 5.2 years STANDARD_DEVIATION 1.7 | 5.5 years STANDARD_DEVIATION 1.8 | 5.9 years STANDARD_DEVIATION 1.7 | 5.6 years STANDARD_DEVIATION 1.7 | 5.5 years STANDARD_DEVIATION 1.7 | 5.5 years STANDARD_DEVIATION 1.7 | 5.5 years STANDARD_DEVIATION 1.7 | 5.5 years STANDARD_DEVIATION 1.7 |
| Sex: Female, Male Female | 81 Participants | 88 Participants | 83 Participants | 83 Participants | 79 Participants | 80 Participants | 75 Participants | 83 Participants | 652 Participants |
| Sex: Female, Male Male | 92 Participants | 81 Participants | 86 Participants | 86 Participants | 90 Participants | 89 Participants | 94 Participants | 87 Participants | 705 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 |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 171 / 171 | 168 / 168 | 169 / 169 | 168 / 168 | 168 / 168 | 168 / 168 | 167 / 167 | 169 / 169 |
| serious Total, serious adverse events | 0 / 171 | 5 / 168 | 7 / 169 | 4 / 168 | 3 / 168 | 4 / 168 | 1 / 167 | 0 / 169 |
Outcome results
Primary
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for \<65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity. PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively. PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.
Time frame: Day 22, Day 29, Day 43, Day 202 and Day 387
Population: The analysis was performed on per protocol set (PPS) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 43 | 99 percentage of subjects |
| 3.75_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Baseline) | 11 percentage of subjects |
| 3.75_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 387 (N=55,63,61,58,61,65,59,63) | 65 percentage of subjects |
| 3.75_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Day 29) | 99 percentage of subjects |
| 3.75_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 202 (N=82,85,84,84,86,87,82,79) | 83 percentage of subjects |
| 3.75_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 22 | 82 percentage of subjects |
| 3.75_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 22 | 84 percentage of subjects |
| 3.75_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 43 | 98 percentage of subjects |
| 3.75_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 387 (N=55,63,61,58,61,65,59,63) | 80 percentage of subjects |
| 3.75_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion (Day 29) | 99 percentage of subjects |
| 3.75_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 202 (N=82,85,84,84,86,87,82,79) | 95 percentage of subjects |
| 7.5 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 43 | 78 percentage of subjects |
| 7.5 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Day 29) | 79 percentage of subjects |
| 7.5 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 202 (N=82,85,84,84,86,87,82,79) | 65 percentage of subjects |
| 7.5 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 202 (N=82,85,84,84,86,87,82,79) | 55 percentage of subjects |
| 7.5 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 387 (N=55,63,61,58,61,65,59,63) | 49 percentage of subjects |
| 7.5 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 22 | 48 percentage of subjects |
| 7.5 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Baseline) | 9 percentage of subjects |
| 7.5 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 43 | 79 percentage of subjects |
| 7.5 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 22 | 46 percentage of subjects |
| 7.5 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion (Day 29) | 78 percentage of subjects |
| 7.5 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 387 (N=55,63,61,58,61,65,59,63) | 56 percentage of subjects |
| 7.5_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 22 | 81 percentage of subjects |
| 7.5_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 43 | 97 percentage of subjects |
| 7.5_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 387 (N=55,63,61,58,61,65,59,63) | 69 percentage of subjects |
| 7.5_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Baseline) | 13 percentage of subjects |
| 7.5_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 22 | 78 percentage of subjects |
| 7.5_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 387 (N=55,63,61,58,61,65,59,63) | 75 percentage of subjects |
| 7.5_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Day 29) | 100 percentage of subjects |
| 7.5_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 202 (N=82,85,84,84,86,87,82,79) | 83 percentage of subjects |
| 7.5_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion (Day 29) | 99 percentage of subjects |
| 7.5_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 202 (N=82,85,84,84,86,87,82,79) | 93 percentage of subjects |
| 7.5_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 43 | 100 percentage of subjects |
| 7.5_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 22 | 88 percentage of subjects |
| 7.5_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 43 | 97 percentage of subjects |
| 7.5_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion (Day 29) | 99 percentage of subjects |
| 7.5_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 387 (N=55,63,61,58,61,65,59,63) | 78 percentage of subjects |
| 7.5_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 387 (N=55,63,61,58,61,65,59,63) | 88 percentage of subjects |
| 7.5_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 202 (N=82,85,84,84,86,87,82,79) | 95 percentage of subjects |
| 7.5_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 43 | 99 percentage of subjects |
| 7.5_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 202 (N=82,85,84,84,86,87,82,79) | 83 percentage of subjects |
| 7.5_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 22 | 91 percentage of subjects |
| 7.5_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Day 29) | 99 percentage of subjects |
| 7.5_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Baseline) | 11 percentage of subjects |
| 15 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 387 (N=55,63,61,58,61,65,59,63) | 49 percentage of subjects |
| 15 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Baseline) | 15 percentage of subjects |
| 15 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 22 | 61 percentage of subjects |
| 15 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 22 | 58 percentage of subjects |
| 15 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Day 29) | 88 percentage of subjects |
| 15 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion (Day 29) | 87 percentage of subjects |
| 15 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 43 | 87 percentage of subjects |
| 15 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 43 | 85 percentage of subjects |
| 15 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 202 (N=82,85,84,84,86,87,82,79) | 74 percentage of subjects |
| 15 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 202 (N=82,85,84,84,86,87,82,79) | 63 percentage of subjects |
| 15 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 387 (N=55,63,61,58,61,65,59,63) | 44 percentage of subjects |
| 15_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Baseline) | 9 percentage of subjects |
| 15_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Day 29) | 100 percentage of subjects |
| 15_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion (Day 29) | 100 percentage of subjects |
| 15_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 202 (N=82,85,84,84,86,87,82,79) | 90 percentage of subjects |
| 15_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 43 | 99 percentage of subjects |
| 15_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 43 | 99 percentage of subjects |
| 15_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 387 (N=55,63,61,58,61,65,59,63) | 75 percentage of subjects |
| 15_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 22 | 82 percentage of subjects |
| 15_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 22 | 82 percentage of subjects |
| 15_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 202 (N=82,85,84,84,86,87,82,79) | 95 percentage of subjects |
| 15_(50)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 387 (N=55,63,61,58,61,65,59,63) | 78 percentage of subjects |
| 15_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 22 | 94 percentage of subjects |
| 15_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 387 (N=55,63,61,58,61,65,59,63) | 81 percentage of subjects |
| 15_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 202 (N=82,85,84,84,86,87,82,79) | 95 percentage of subjects |
| 15_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Baseline) | 8 percentage of subjects |
| 15_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 43 | 100 percentage of subjects |
| 15_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 43 | 99 percentage of subjects |
| 15_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Day 29) | 100 percentage of subjects |
| 15_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 387 (N=55,63,61,58,61,65,59,63) | 71 percentage of subjects |
| 15_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 202 (N=82,85,84,84,86,87,82,79) | 90 percentage of subjects |
| 15_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion (Day 29) | 100 percentage of subjects |
| 15_(100)MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 22 | 92 percentage of subjects |
| 30 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 202 (N=82,85,84,84,86,87,82,79) | 66 percentage of subjects |
| 30 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion (Day 29) | 94 percentage of subjects |
| 30 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 202 (N=82,85,84,84,86,87,82,79) | 81 percentage of subjects |
| 30 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Day 29) | 97 percentage of subjects |
| 30 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 43 | 88 percentage of subjects |
| 30 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 22 | 60 percentage of subjects |
| 30 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 22 | 65 percentage of subjects |
| 30 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 387 (N=55,63,61,58,61,65,59,63) | 65 percentage of subjects |
| 30 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 (Baseline) | 12 percentage of subjects |
| 30 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | HI titer ≥1:40 day 43 | 92 percentage of subjects |
| 30 Without MF59 | Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations | Seroconversion day 387 (N=55,63,61,58,61,65,59,63) | 51 percentage of subjects |
Secondary
Antibody Response Based on Baseline Seropositivity
Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline. Subgroups with baseline HI titer \< 1:10: PPS Day 1-29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively. Subgroups with baseline HI titer ≥ 1:10: PPS Day 1-29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively.
Time frame: Day 22, Day 29 and Day 43
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI < 1:10 | 99 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI <1:10 | 99 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI ≥ 1:10 | 95 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI ≥1:10 | 90 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI ≥1:10 | 38 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI ≥ 1:10 | 97 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI < 1:10 | 81 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI < 1:10 | 99 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI ≥ 1:10 | 83 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI ≥1:10 | 100 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI <1:10 | 81 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI <1:10 | 0 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI ≥1:10 | 100 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI <1:10 | 99 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI ≥1:10 | 91 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI ≥ 1:10 | 69 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI <1:10 | 0 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI <1:10 | 39 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI ≥1:10 | 91 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI ≥1:10 | 40 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI <1:10 | 75 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI < 1:10 | 39 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI ≥1:10 | 80 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI ≥ 1:10 | 86 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI < 1:10 | 75 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI <1:10 | 75 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI ≥ 1:10 | 88 percentage of Subjects |
| 7.5 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI < 1:10 | 75 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI ≥1:10 | 100 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI < 1:10 | 100 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI < 1:10 | 100 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI <1:10 | 100 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI <1:10 | 79 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI ≥1:10 | 49 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI ≥ 1:10 | 95 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI <1:10 | 0 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI < 1:10 | 79 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI <1:10 | 100 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI ≥1:10 | 100 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI ≥ 1:10 | 88 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI ≥ 1:10 | 73 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI ≥1:10 | 85 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI <1:10 | 90 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI <1:10 | 98 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI ≥1:10 | 93 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI ≥1:10 | 41 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI ≥1:10 | 100 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI ≥ 1:10 | 95 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI < 1:10 | 90 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI < 1:10 | 98 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI ≥ 1:10 | 100 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI < 1:10 | 98 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI ≥ 1:10 | 83 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI <1:10 | 0 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI <1:10 | 98 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI ≥1:10 | 100 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI <1:10 | 54 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI ≥1:10 | 97 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI ≥1:10 | 98 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI < 1:10 | 54 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI < 1:10 | 85 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI < 1:10 | 83 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI <1:10 | 0 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI ≥1:10 | 80 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI <1:10 | 85 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI <1:10 | 83 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI ≥ 1:10 | 71 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI ≥ 1:10 | 92 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI ≥ 1:10 | 88 percentage of Subjects |
| 15 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI ≥1:10 | 59 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI <1:10 | 78 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI ≥ 1:10 | 97 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI ≥1:10 | 38 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI < 1:10 | 100 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI < 1:10 | 78 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI ≥ 1:10 | 100 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI <1:10 | 0 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI ≥1:10 | 97 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI <1:10 | 100 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI < 1:10 | 99 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI ≥1:10 | 100 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI ≥ 1:10 | 95 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI <1:10 | 99 percentage of Subjects |
| 15_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI ≥1:10 | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI <1:10 | 92 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI <1:10 | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI < 1:10 | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI ≥ 1:10 | 89 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI <1:10 | 0 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI < 1:10 | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI ≥ 1:10 | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI < 1:10 | 92 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI ≥1:10 | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI ≥ 1:10 | 96 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI ≥1:10 | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI ≥1:10 | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI ≥1:10 | 43 percentage of Subjects |
| 15_(100)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI <1:10 | 100 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI ≥1:10 | 45 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI ≥ 1:10 | 81 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1)_ baseline HI <1:10 | 0 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI ≥ 1:10 | 57 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI ≥1:10 | 95 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 29)_ baseline HI <1:10 | 97 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1)_baseline HI < 1:10 | 91 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI ≥ 1:10 | 85 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1)_baseline HI < 1:10 | 61 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI <1:10 | 91 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI ≥1:10 | 76 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43)_ baseline HI ≥1:10 | 93 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22)_ baseline HI <1:10 | 61 percentage of Subjects |
| 30 Without MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 29/Day 1)_baseline HI < 1:10 | 97 percentage of Subjects |
Secondary
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is \> 40%.The percentage of subjects achieving an HI titer ≥ 40 is \> 70% and The GMR is \> 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1-22 and Day1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.
Time frame: Day 22, Day 29, Day 43
Population: The analysis was done on PPS population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1) without flu vac | 10 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43) without flu vac | 99 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)with seasonal flu va | 91 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43)_ with seasonal flu vac | 100 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1)_ with seasonal flu vac | 18 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)without flu vac | 98 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)without flu vac | 84 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)with seasonal flu vac | 73 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)with seasonal flu vac | 100 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)without flu vac | 82 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)_ with seasonal flu vac | 73 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)without flu vac | 99 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29)_ with seasonal flu vac | 100 percentage of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29) without flu vac | 99 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29)_ with seasonal flu vac | 67 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)without flu vac | 47 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43)_ with seasonal flu vac | 78 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)with seasonal flu vac | 67 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29) without flu vac | 79 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)without flu vac | 49 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)with seasonal flu va | 78 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)with seasonal flu vac | 22 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1) without flu vac | 8 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1)_ with seasonal flu vac | 22 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)without flu vac | 78 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)_ with seasonal flu vac | 33 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43) without flu vac | 79 percentage of Subjects |
| 7.5 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)without flu vac | 79 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)without flu vac | 80 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)without flu vac | 98 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29) without flu vac | 100 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)with seasonal flu vac | 83 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)with seasonal flu vac | 83 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)without flu vac | 77 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)_ with seasonal flu vac | 100 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43)_ with seasonal flu vac | 100 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1) without flu vac | 11 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)without flu vac | 99 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)with seasonal flu va | 67 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29)_ with seasonal flu vac | 100 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1)_ with seasonal flu vac | 50 percentage of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43) without flu vac | 100 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1) without flu vac | 9 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)with seasonal flu vac | 100 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)with seasonal flu vac | 100 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)with seasonal flu va | 88 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1)_ with seasonal flu vac | 38 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)_ with seasonal flu vac | 100 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29)_ with seasonal flu vac | 100 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43)_ with seasonal flu vac | 100 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)without flu vac | 88 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)without flu vac | 99 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)without flu vac | 98 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)without flu vac | 91 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29) without flu vac | 99 percentage of Subjects |
| 7.5_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43) without flu vac | 99 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1) without flu vac | 16 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43)_ with seasonal flu vac | 78 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)with seasonal flu va | 78 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)without flu vac | 62 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)_ with seasonal flu vac | 44 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)without flu vac | 88 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)with seasonal flu vac | 44 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)without flu vac | 59 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43) without flu vac | 88 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)without flu vac | 85 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29) without flu vac | 90 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1)_ with seasonal flu vac | 0 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)with seasonal flu vac | 67 percentage of Subjects |
| 15 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29)_ with seasonal flu vac | 67 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)with seasonal flu va | 100 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1) without flu vac | 9 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29)_ with seasonal flu vac | 100 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)with seasonal flu vac | 100 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29) without flu vac | 100 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)without flu vac | 83 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43)_ with seasonal flu vac | 100 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43) without flu vac | 99 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)without flu vac | 99 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)_ with seasonal flu vac | 73 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1)_ with seasonal flu vac | 9 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)with seasonal flu vac | 73 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)without flu vac | 82 percentage of Subjects |
| 15_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)without flu vac | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)with seasonal flu vac | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)without flu vac | 91 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)_ with seasonal flu vac | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)without flu vac | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1)_ with seasonal flu vac | 17 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)without flu vac | 99 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)with seasonal flu va | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1) without flu vac | 7 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)with seasonal flu vac | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)without flu vac | 93 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43) without flu vac | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29) without flu vac | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29)_ with seasonal flu vac | 100 percentage of Subjects |
| 15_(100)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43)_ with seasonal flu vac | 100 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)with seasonal flu vac | 71 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 22/Day 1)without flu vac | 60 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)without flu vac | 88 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1)_ with seasonal flu vac | 0 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)_ with seasonal flu vac | 71 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29) without flu vac | 96 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)without flu vac | 94 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 29)_ with seasonal flu vac | 100 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43)_ with seasonal flu vac | 86 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 29/Day 1)with seasonal flu vac | 83 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 43) without flu vac | 92 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 22)without flu vac | 65 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | HI titer ≥1:40 (Day 1) without flu vac | 13 percentage of Subjects |
| 30 Without MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. | Seroconversion (Day 43/Day 1)with seasonal flu va | 86 percentage of Subjects |
Secondary
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group. PPS Day1-29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.
Time frame: Day 22, Day 29, Day 43, Day 202 and Day 387
Population: The analysis was performed on per protocol set (PPS) population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 3.75_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Baseline | 8.5 Titers |
| 3.75_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 387 (N=55,63,61,58,61,65,59,63) | 54 Titers |
| 3.75_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 43 | 560 Titers |
| 3.75_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Day 29 | 747 Titers |
| 3.75_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 22 | 107 Titers |
| 3.75_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 202 (N=143,149,149,146,147,147,144,144) | 117 Titers |
| 7.5 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Day 29 | 138 Titers |
| 7.5 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 202 (N=143,149,149,146,147,147,144,144) | 45 Titers |
| 7.5 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Baseline | 7.3 Titers |
| 7.5 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 22 | 27 Titers |
| 7.5 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 43 | 113 Titers |
| 7.5 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 387 (N=55,63,61,58,61,65,59,63) | 28 Titers |
| 7.5_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 202 (N=143,149,149,146,147,147,144,144) | 107 Titers |
| 7.5_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 43 | 480 Titers |
| 7.5_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Baseline | 8.7 Titers |
| 7.5_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 22 | 88 Titers |
| 7.5_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Day 29 | 685 Titers |
| 7.5_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 387 (N=55,63,61,58,61,65,59,63) | 57 Titers |
| 7.5_(100)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Baseline | 8.7 Titers |
| 7.5_(100)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 22 | 163 Titers |
| 7.5_(100)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 43 | 637 Titers |
| 7.5_(100)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Day 29 | 984 Titers |
| 7.5_(100)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 202 (N=143,149,149,146,147,147,144,144) | 132 Titers |
| 7.5_(100)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 387 (N=55,63,61,58,61,65,59,63) | 70 Titers |
| 15 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 387 (N=55,63,61,58,61,65,59,63) | 30 Titers |
| 15 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 22 | 49 Titers |
| 15 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 43 | 174 Titers |
| 15 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Day 29 | 214 Titers |
| 15 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Baseline | 9.1 Titers |
| 15 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 202 (N=143,149,149,146,147,147,144,144) | 55 Titers |
| 15_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 387 (N=55,63,61,58,61,65,59,63) | 59 Titers |
| 15_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 43 | 524 Titers |
| 15_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 202 (N=143,149,149,146,147,147,144,144) | 134 Titers |
| 15_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 22 | 106 Titers |
| 15_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Baseline | 7.5 Titers |
| 15_(50)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Day 29 | 761 Titers |
| 15_(100)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Baseline | 7 Titers |
| 15_(100)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 387 (N=55,63,61,58,61,65,59,63) | 63 Titers |
| 15_(100)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 43 | 778 Titers |
| 15_(100)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 202 (N=143,149,149,146,147,147,144,144) | 131 Titers |
| 15_(100)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Day 29 | 1070 Titers |
| 15_(100)MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 22 | 160 Titers |
| 30 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 22 | 62 Titers |
| 30 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 387 (N=55,63,61,58,61,65,59,63) | 45 Titers |
| 30 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Baseline | 9.1 Titers |
| 30 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 43 | 223 Titers |
| 30 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMTs day 202 (N=143,149,149,146,147,147,144,144) | 81 Titers |
| 30 Without MF59 | Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group | GMT Day 29 | 297 Titers |
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [2.659, 6.009]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.813, 1.838]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.44, 0.994]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.449, 3.276]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.676, 1.528]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.448, 1.012]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.156, 2.626]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.204, 0.458]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.11, 0.248]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.363, 0.818]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.17, 0.381]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.112, 0.252]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.29, 0.655]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.361, 0.811]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.188, 2.676]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.555, 1.246]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.367, 0.826]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.95, 2.14]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [2.196, 4.944]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.026, 2.303]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.679, 1.526]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.754, 3.959]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.311, 0.7]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.206, 0.463]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other95% CI: [0.532, 1.203]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.442, 0.992]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.142, 2.572]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.723, 3.889]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [3.757, 6.589]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.881, 1.547]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.665, 1.166]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [2.43, 4.264]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.808, 1.417]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.544, 0.954]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.891, 3.33]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.178, 0.31]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.134, 0.234]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.489, 0.856]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.163, 0.284]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.109, 0.191]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.381, 0.668]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.57, 0.997]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [2.083, 3.647]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.694, 1.211]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.466, 1.815]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.624, 2.843]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [2.764, 4.836]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.92, 1.606]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.619, 1.081]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [2.152, 3.773]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.251, 0.44]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.169, 0.296]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.588, 1.003]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.509, 0.889]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.772, 3.102]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [2.633, 4.614]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.817, 3.789]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.76, 1.58]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.615, 1.282]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.473, 3.052]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.61, 1.26]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.622, 1.298]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1, 2.105]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.289, 0.603]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.235, 0.487]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.561, 1.165]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.233, 0.479]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.237, 0.494]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.382, 0.801]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.562, 1.169]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.347, 2.78]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.558, 1.147]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.568, 1.184]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.915, 1.917]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.658, 3.438]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.688, 1.416]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.701, 1.46]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.128, 2.366]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.288, 0.592]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.294, 0.61]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.473, 0.99]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.714, 1.473]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.15, 2.385]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.115, 2.339]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.177, 3.087]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.583, 1.533]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.468, 1.245]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.119, 2.956]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.568, 1.481]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.524, 1.396]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.745, 1.943]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.31, 0.794]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.25, 0.641]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.596, 1.528]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.306, 0.758]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.279, 0.722]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.398, 1.002]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.5, 1.304]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.193, 3.102]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.611, 1.541]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.561, 1.46]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.798, 2.03]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.474, 3.851]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.754, 1.915]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.689, 1.821]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.987, 2.516]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.316, 0.805]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.293, 0.754]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.414, 1.056]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.583, 1.492]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.831, 2.071]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.88, 2.249]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [4, 7.365]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.804, 1.481]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.559, 1.031]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other95% CI: [2.577, 4.751]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.722, 1.334]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other95% CI: [0.513, 0.95]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.846, 3.421]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.149, 0.272]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.103, 0.189]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.476, 0.873]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other95% CI: [0.134, 0.245]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.095, 0.174]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other95% CI: [0.341, 0.628]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other95% CI: [0.514, 0.943]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [2.368, 4.343]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.665, 1.218]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.472, 0.868]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.7, 3.121]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [3.398, 6.249]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.954, 1.753]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.677, 1.249]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other95% CI: [2.436, 4.496]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.207, 0.38]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.147, 0.271]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.529, 0.975]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [0.524, 0.966]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.95% CI: [1.886, 3.474]
Comparison: A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other95% CI: [2.646, 4.89]
Secondary
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline. Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline \[Day 1 (pre-vaccination)\] as compared to those who are seronegative (HI titer \< 1:10).
Time frame: Day 1, Day 22, Day 29, Day 43
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 29HI <1:10(110,121,115,115,114,120,128,11 | 664 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 22 HI<1:10(110,121,115,115,114,120,128,11 | 80 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 1 HI <1:10(110,121,115,115,114,120,128,11 | 5 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 43HI <1:10(110,121,115,115,114,120,128,11 | 490 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 1 HI ≥ 1:10(42,35,41,41,41,37,28,42) | 40 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 22_HI ≥1:10(42,35,41,41,41,37,28,42) | 343 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 29_HI ≥1:10(42,35,41,41,41,37,28,42) | 1178 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 43_HI ≥1:10(42,35,41,41,41,37,28,42) | 876 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 1 HI ≥ 1:10(42,35,41,41,41,37,28,42) | 32 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 29HI <1:10(110,121,115,115,114,120,128,11 | 100 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 22_HI ≥1:10(42,35,41,41,41,37,28,42) | 132 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 29_HI ≥1:10(42,35,41,41,41,37,28,42) | 460 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 1 HI <1:10(110,121,115,115,114,120,128,11 | 5 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 43HI <1:10(110,121,115,115,114,120,128,11 | 85 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 22 HI<1:10(110,121,115,115,114,120,128,11 | 18 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 43_HI ≥1:10(42,35,41,41,41,37,28,42) | 320 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 29_HI ≥1:10(42,35,41,41,41,37,28,42) | 1063 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 1 HI ≥ 1:10(42,35,41,41,41,37,28,42) | 47 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 43_HI ≥1:10(42,35,41,41,41,37,28,42) | 657 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 29HI <1:10(110,121,115,115,114,120,128,11 | 638 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 22_HI ≥1:10(42,35,41,41,41,37,28,42) | 311 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 43HI <1:10(110,121,115,115,114,120,128,11 | 437 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 1 HI <1:10(110,121,115,115,114,120,128,11 | 5.1 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 22 HI<1:10(110,121,115,115,114,120,128,11 | 62 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 43_HI ≥1:10(42,35,41,41,41,37,28,42) | 881 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 22 HI<1:10(110,121,115,115,114,120,128,11 | 130 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 1 HI <1:10(110,121,115,115,114,120,128,11 | 5.1 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 43HI <1:10(110,121,115,115,114,120,128,11 | 568 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 29HI <1:10(110,121,115,115,114,120,128,11 | 885 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 1 HI ≥ 1:10(42,35,41,41,41,37,28,42) | 32 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 22_HI ≥1:10(42,35,41,41,41,37,28,42) | 320 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 29_HI ≥1:10(42,35,41,41,41,37,28,42) | 1281 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 43HI <1:10(110,121,115,115,114,120,128,11 | 121 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 29_HI ≥1:10(42,35,41,41,41,37,28,42) | 543 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 29HI <1:10(110,121,115,115,114,120,128,11 | 149 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 1 HI <1:10(110,121,115,115,114,120,128,11 | 5 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 43_HI ≥1:10(42,35,41,41,41,37,28,42) | 464 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 1 HI ≥ 1:10(42,35,41,41,41,37,28,42) | 52 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 22_HI ≥1:10(42,35,41,41,41,37,28,42) | 284 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 22 HI<1:10(110,121,115,115,114,120,128,11 | 26 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 43_HI ≥1:10(42,35,41,41,41,37,28,42) | 838 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 22 HI<1:10(110,121,115,115,114,120,128,11 | 72 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 29HI <1:10(110,121,115,115,114,120,128,11 | 685 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 1 HI <1:10(110,121,115,115,114,120,128,11 | 5 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 29_HI ≥1:10(42,35,41,41,41,37,28,42) | 1197 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 22_HI ≥1:10(42,35,41,41,41,37,28,42) | 417 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 1 HI ≥ 1:10(42,35,41,41,41,37,28,42) | 35 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 43HI <1:10(110,121,115,115,114,120,128,11 | 463 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 29HI <1:10(110,121,115,115,114,120,128,11 | 950 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 22 HI<1:10(110,121,115,115,114,120,128,11 | 130 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 43HI <1:10(110,121,115,115,114,120,128,11 | 717 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 1 HI ≥ 1:10(42,35,41,41,41,37,28,42) | 40 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 22_HI ≥1:10(42,35,41,41,41,37,28,42) | 460 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 43_HI ≥1:10(42,35,41,41,41,37,28,42) | 1184 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 29_HI ≥1:10(42,35,41,41,41,37,28,42) | 2088 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 1 HI <1:10(110,121,115,115,114,120,128,11 | 5.1 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 43_HI ≥1:10(42,35,41,41,41,37,28,42) | 428 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 22_HI ≥1:10(42,35,41,41,41,37,28,42) | 252 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 1 HI ≥ 1:10(42,35,41,41,41,37,28,42) | 48 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 43HI <1:10(110,121,115,115,114,120,128,11 | 177 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 29HI <1:10(110,121,115,115,114,120,128,11 | 234 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 22 HI<1:10(110,121,115,115,114,120,128,11 | 39 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMTDay 1 HI <1:10(110,121,115,115,114,120,128,11 | 5.1 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | GMT Day 29_HI ≥1:10(42,35,41,41,41,37,28,42) | 641 Titers |
Secondary
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines Subgroups without recent seasonal flu vaccine: PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively. Subgroups with recent seasonal flu vaccine:PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively. PPS Day 1-29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively
Time frame: Day 1, Day 22, Day 29, Day 43
Population: The analysis was done on PPS population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ with seasonal flu vaccination | 278 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ with seasonal flu vaccination | 36 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_with seasonal flu vaccination | 6.22 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ with seasonal flu vaccination | 260 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_without seasonal flu vaccination | 8.54 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ without seasonal flu vaccination | 115 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ without seasonal flu vaccination | 810 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ without seasonal flu vaccination | 600 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_without seasonal flu vaccination | 7.08 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ with seasonal flu vaccination | 171 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ without seasonal flu vaccination | 28 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ without seasonal flu vaccination | 144 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_with seasonal flu vaccination | 12 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ with seasonal flu vaccination | 182 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ with seasonal flu vaccination | 44 Titers |
| 7.5 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ without seasonal flu vaccination | 115 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ without seasonal flu vaccination | 669 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_without seasonal flu vaccination | 8.3 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ without seasonal flu vaccination | 477 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ with seasonal flu vaccination | 785 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ without seasonal flu vaccination | 85 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ with seasonal flu vaccination | 503 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_with seasonal flu vaccination | 22 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ with seasonal flu vaccination | 196 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ without seasonal flu vaccination | 643 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ with seasonal flu vaccination | 209 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_with seasonal flu vaccination | 15 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ with seasonal flu vaccination | 594 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ with seasonal flu vaccination | 1186 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_without seasonal flu vaccination | 7.76 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ without seasonal flu vaccination | 159 Titers |
| 7.5_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ without seasonal flu vaccination | 968 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ with seasonal flu vaccination | 81 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ without seasonal flu vaccination | 228 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ with seasonal flu vaccination | 137 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_with seasonal flu vaccination | 5.42 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ without seasonal flu vaccination | 182 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_without seasonal flu vaccination | 9.35 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ without seasonal flu vaccination | 52 Titers |
| 15 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ with seasonal flu vaccination | 48 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ without seasonal flu vaccination | 520 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ with seasonal flu vaccination | 44 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ with seasonal flu vaccination | 670 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_with seasonal flu vaccination | 5.99 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ without seasonal flu vaccination | 756 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ without seasonal flu vaccination | 109 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_without seasonal flu vaccination | 7.47 Titers |
| 15_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ with seasonal flu vaccination | 663 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ with seasonal flu vaccination | 771 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ with seasonal flu vaccination | 345 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ with seasonal flu vaccination | 1035 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_without seasonal flu vaccination | 6.8 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ without seasonal flu vaccination | 158 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ without seasonal flu vaccination | 770 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ without seasonal flu vaccination | 1080 Titers |
| 15_(100)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_with seasonal flu vaccination | 15 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ without seasonal flu vaccination | 224 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ without seasonal flu vaccination | 62 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_without seasonal flu vaccination | 9.1 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43_ with seasonal flu vaccination | 228 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ with seasonal flu vaccination | 184 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22_ with seasonal flu vaccination | 111 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1_with seasonal flu vaccination | 9.36 Titers |
| 30 Without MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 29_ without seasonal flu vaccination | 297 Titers |
Secondary
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)
Time frame: Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination
Population: The analysis was done on unsolicited safety set population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic dis. | 2 Subjects |
| 3.75_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 1-43) | 0 Subjects |
| 3.75_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visits(Days 1-43) | 31 Subjects |
| 3.75_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 1-43) | 98 Subjects |
| 3.75_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visit(Days44-387) | 95 Subjects |
| 3.75_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 44-387) | 0 Subjects |
| 3.75_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 44-387) | 0 Subjects |
| 3.75_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic disorder | 0 Subjects |
| 3.75_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 1-43) | 0 Subjects |
| 3.75_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 44-387) | 95 Subjects |
| 7.5 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 44-387) | 5 Subjects |
| 7.5 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 44-387) | 98 Subjects |
| 7.5 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 1-43) | 0 Subjects |
| 7.5 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 1-43) | 80 Subjects |
| 7.5 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visit(Days44-387) | 97 Subjects |
| 7.5 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 1-43) | 0 Subjects |
| 7.5 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic dis. | 7 Subjects |
| 7.5 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic disorder | 0 Subjects |
| 7.5 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 44-387) | 0 Subjects |
| 7.5 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visits(Days 1-43) | 34 Subjects |
| 7.5_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic dis. | 4 Subjects |
| 7.5_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 1-43) | 1 Subjects |
| 7.5_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visit(Days44-387) | 102 Subjects |
| 7.5_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic disorder | 0 Subjects |
| 7.5_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 1-43) | 80 Subjects |
| 7.5_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 44-387) | 1 Subjects |
| 7.5_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 44-387) | 6 Subjects |
| 7.5_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 44-387) | 102 Subjects |
| 7.5_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visits(Days 1-43) | 25 Subjects |
| 7.5_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 1-43) | 1 Subjects |
| 7.5_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 1-43) | 0 Subjects |
| 7.5_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 1-43) | 85 Subjects |
| 7.5_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visit(Days44-387) | 93 Subjects |
| 7.5_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 44-387) | 0 Subjects |
| 7.5_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 44-387) | 93 Subjects |
| 7.5_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 44-387) | 4 Subjects |
| 7.5_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visits(Days 1-43) | 40 Subjects |
| 7.5_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic disorder | 0 Subjects |
| 7.5_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 1-43) | 0 Subjects |
| 7.5_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic dis. | 3 Subjects |
| 15 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 1-43) | 0 Subjects |
| 15 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 1-43) | 86 Subjects |
| 15 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 1-43) | 0 Subjects |
| 15 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic disorder | 0 Subjects |
| 15 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visits(Days 1-43) | 34 Subjects |
| 15 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 44-387) | 90 Subjects |
| 15 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 44-387) | 3 Subjects |
| 15 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 44-387) | 0 Subjects |
| 15 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic dis. | 4 Subjects |
| 15 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visit(Days44-387) | 90 Subjects |
| 15_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visit(Days44-387) | 100 Subjects |
| 15_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 44-387) | 0 Subjects |
| 15_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 44-387) | 4 Subjects |
| 15_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 1-43) | 0 Subjects |
| 15_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visits(Days 1-43) | 35 Subjects |
| 15_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 1-43) | 93 Subjects |
| 15_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 1-43) | 0 Subjects |
| 15_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 44-387) | 101 Subjects |
| 15_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic disorder | 1 Subjects |
| 15_(50)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic dis. | 3 Subjects |
| 15_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visits(Days 1-43) | 28 Subjects |
| 15_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 44-387) | 1 Subjects |
| 15_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic disorder | 0 Subjects |
| 15_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 44-387) | 0 Subjects |
| 15_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 1-43) | 0 Subjects |
| 15_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 1-43) | 79 Subjects |
| 15_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visit(Days44-387) | 89 Subjects |
| 15_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic dis. | 6 Subjects |
| 15_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 1-43) | 0 Subjects |
| 15_(100)MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 44-387) | 90 Subjects |
| 30 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 44-387) | 95 Subjects |
| 30 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic dis. | 3 Subjects |
| 30 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visit(Days44-387) | 95 Subjects |
| 30 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to new onset of chronic disorder | 0 Subjects |
| 30 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs: all (Days 1-43) | 79 Subjects |
| 30 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 44-387) | 0 Subjects |
| 30 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 44-387) | 0 Subjects |
| 30 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | SAEs: all (Days 1-43) | 0 Subjects |
| 30 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AE leading to medically attended visits(Days 1-43) | 24 Subjects |
| 30 Without MF59 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | AEs leading to premature withdrawal (Days 1-43) | 0 Subjects |
Secondary
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).
Time frame: 7 days after first vaccination
Population: The analysis was performed on safety set population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Tenderness | 72 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Erythema | 3 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Swelling | 8 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Induration | 14 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Pain | 62 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Chills | 8 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Myalgia | 16 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Arthralgia | 7 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Headache | 24 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Nausea | 10 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Vomiting | 4 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Diarrhoea | 12 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fatigue | 27 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fever | 9 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Stayed home | 1 Participants |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Analgesic./anti pyretic used | 1 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Headache | 15 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Tenderness | 49 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Induration | 5 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Myalgia | 8 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fatigue | 17 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Swelling | 5 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Diarrhoea | 7 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Pain | 43 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Vomiting | 5 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Chills | 3 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Arthralgia | 3 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Erythema | 2 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fever | 10 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Stayed home | 0 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Nausea | 14 Participants |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Analgesic./anti pyretic used | 0 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fatigue | 23 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Myalgia | 13 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Arthralgia | 9 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Pain | 52 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Swelling | 5 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Induration | 10 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fever | 13 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Stayed home | 0 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Headache | 30 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Tenderness | 59 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Erythema | 4 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Diarrhoea | 6 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Vomiting | 10 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Chills | 9 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Analgesic./anti pyretic used | 0 Participants |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Nausea | 13 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fatigue | 29 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Swelling | 7 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Stayed home | 0 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Induration | 12 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Tenderness | 96 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Chills | 11 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Myalgia | 27 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Arthralgia | 7 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Headache | 37 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Nausea | 14 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Vomiting | 4 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Analgesic./anti pyretic used | 0 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Diarrhoea | 2 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fever | 14 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Pain | 86 Participants |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Erythema | 3 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Myalgia | 8 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Tenderness | 50 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Stayed home | 0 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Pain | 47 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fatigue | 17 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Arthralgia | 3 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fever | 9 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Chills | 5 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Headache | 16 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Swelling | 11 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Vomiting | 5 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Nausea | 7 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Induration | 10 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Erythema | 1 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Diarrhoea | 10 Participants |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Analgesic./anti pyretic used | 0 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Headache | 25 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Stayed home | 1 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Nausea | 11 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Myalgia | 15 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Tenderness | 78 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fatigue | 23 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Vomiting | 8 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Arthralgia | 8 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Analgesic./anti pyretic used | 0 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Pain | 65 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Induration | 11 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Erythema | 1 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Diarrhoea | 3 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fever | 17 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Swelling | 11 Participants |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Chills | 8 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Induration | 15 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Erythema | 6 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Pain | 72 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Myalgia | 17 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Nausea | 12 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Arthralgia | 7 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Swelling | 10 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Vomiting | 5 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Headache | 27 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Tenderness | 69 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Diarrhoea | 4 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Stayed home | 1 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fatigue | 29 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Chills | 8 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Analgesic./anti pyretic used | 0 Participants |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fever | 16 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Arthralgia | 3 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Headache | 17 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Chills | 8 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Nausea | 9 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Tenderness | 60 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Vomiting | 5 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Erythema | 5 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Diarrhoea | 6 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Induration | 12 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fatigue | 16 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Fever | 7 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Swelling | 6 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Myalgia | 12 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Stayed home | 0 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Pain | 51 Participants |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination | Analgesic./anti pyretic used | 0 Participants |
Secondary
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)
Time frame: 7 days after second vaccination
Population: The analysis was performed on safety set population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Tenderness | 55 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Pain | 53 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Erythema | 4 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Swelling | 8 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Induration | 10 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Chills | 7 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Myalgia | 12 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Arthralgia | 2 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Headache | 12 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Nausea | 11 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Vomiting | 6 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Diarrhoea | 6 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fatigue | 16 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fever | 10 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Stayed home | 1 Participant |
| 3.75_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Analgesic/anti pyretic used | 0 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Headache | 12 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Myalgia | 4 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Erythema | 1 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Arthralgia | 0 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Pain | 35 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Induration | 2 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Stayed home | 0 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fever | 6 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fatigue | 11 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Tenderness | 42 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Swelling | 5 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Diarrhoea | 6 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Vomiting | 3 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Chills | 5 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Nausea | 7 Participant |
| 7.5 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Analgesic/anti pyretic used | 0 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Analgesic/anti pyretic used | 0 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Headache | 12 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Myalgia | 9 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Tenderness | 50 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Arthralgia | 1 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Chills | 5 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Stayed home | 0 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Pain | 46 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Diarrhoea | 5 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Erythema | 4 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Induration | 9 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Swelling | 10 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Vomiting | 4 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fever | 5 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Nausea | 5 Participant |
| 7.5_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fatigue | 15 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fatigue | 14 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Swelling | 9 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Induration | 6 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Tenderness | 65 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Chills | 4 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Myalgia | 16 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Arthralgia | 4 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Headache | 19 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Nausea | 6 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Vomiting | 7 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Analgesic/anti pyretic used | 0 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Diarrhoea | 5 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Stayed home | 0 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fever | 5 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Pain | 59 Participant |
| 7.5_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Erythema | 5 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Analgesic/anti pyretic used | 0 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Induration | 9 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fatigue | 17 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Chills | 7 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fever | 10 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Myalgia | 6 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Erythema | 5 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Nausea | 8 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Headache | 14 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Pain | 42 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Vomiting | 3 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Arthralgia | 2 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Tenderness | 38 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Swelling | 11 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Diarrhoea | 7 Participant |
| 15 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Stayed home | 1 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Stayed home | 0 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Tenderness | 67 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fever | 8 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Chills | 4 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Headache | 11 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fatigue | 10 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Arthralgia | 2 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Pain | 57 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Analgesic/anti pyretic used | 0 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Vomiting | 3 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Induration | 15 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Diarrhoea | 7 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Erythema | 4 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Nausea | 16 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Swelling | 10 Participant |
| 15_(50)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Myalgia | 8 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Chills | 3 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Stayed home | 0 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Pain | 48 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Headache | 13 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Nausea | 4 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Tenderness | 57 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Swelling | 12 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Vomiting | 3 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Diarrhoea | 2 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Erythema | 5 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fatigue | 13 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Induration | 13 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fever | 7 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Analgesic/anti pyretic used | 0 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Myalgia | 9 Participant |
| 15_(100)MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Arthralgia | 0 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Chills | 3 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Erythema | 5 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Diarrhoea | 4 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Swelling | 10 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Vomiting | 3 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Tenderness | 54 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Arthralgia | 2 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Myalgia | 15 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Stayed home | 0 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Nausea | 5 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Pain | 50 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Analgesic/anti pyretic used | 1 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fatigue | 6 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Induration | 10 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Headache | 9 Participant |
| 30 Without MF59 | Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination | Fever | 4 Participant |