Influenza
Conditions
Keywords
Swine Flu, Flu, Vaccine, Children, Adjuvant, A/H1N1 2009 Influenza
Brief summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
Interventions
BIOLOGICALMF59-eH1N1_f
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
Sponsors
Novartis
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
* Children 6 to 35 months 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 After the First and Second Vaccinations | 21 days after each vaccination | CBER guidance (\<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. |
| Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Day 1 to 7 | Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination. |
| Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Day 22 to 28 | Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response Based on Baseline Seropositivity | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) | Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10 |
| Immunogenicity Measurement by Geometric Mean Titers (GMT) | 21 days after each vaccination | Immunogenicity was measured in terms of the GMT at 21 days after each vaccination. |
| Antibody Persistence by Geometric Mean Titers (GMT) | 6 months (Day 202) and 12 months (Day 387) after second vaccination | Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination. |
| Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) | Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10 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). |
| Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) | Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines. |
| Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) | Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines. |
Countries
Mexico, United States
Participant flow
Recruitment details
Participants were enrolled at 29 sites in USA and Mexico. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Pre-assignment details
All subjects enrolled were included in the trial. The data entered is for the overall study.
Participants by arm
| Arm | Count |
|---|---|
| 3.75_(50)MF59 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 164 |
| 7.5_(0)MF59 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 165 |
| 7.5_(50)MF59 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 160 |
| 15_(0)MF59 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 165 |
| Total | 654 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative reason | 0 | 1 | 0 | 0 |
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 13 | 13 | 7 | 15 |
| Overall Study | Unable to classify | 4 | 0 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 5 | 5 |
Baseline characteristics
| Characteristic | 3.75_(50)MF59 | 7.5_(0)MF59 | 7.5_(50)MF59 | 15_(0)MF59 | Total |
|---|---|---|---|---|---|
| Age, Continuous 6 to <36 Months age | 21.2 Months STANDARD_DEVIATION 7.9 | 21.6 Months STANDARD_DEVIATION 8.8 | 21.1 Months STANDARD_DEVIATION 8.4 | 21.3 Months STANDARD_DEVIATION 8.9 | 21.3 Months STANDARD_DEVIATION 8.5 |
| Sex: Female, Male Female | 75 Participants | 79 Participants | 80 Participants | 78 Participants | 312 Participants |
| Sex: Female, Male Male | 89 Participants | 86 Participants | 80 Participants | 87 Participants | 342 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 144 / 162 | 152 / 164 | 141 / 162 | 142 / 166 |
| serious Total, serious adverse events | 5 / 162 | 6 / 164 | 1 / 162 | 10 / 166 |
Outcome results
Primary
Antibody Responses After the First and Second Vaccinations
CBER guidance (\<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
Time frame: 21 days after each vaccination
Population: The analysis was done on the per-protocol set (PPS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 43 | 98 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 202;N=45,38,46,38) | 96 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 202;N=45,38,46,38) | 89 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Baseline) | 19 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 387;N=45,38,46,38) | 76 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 22 | 74 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 43) | 100 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 22) | 79 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 387;N=46,37,38,36) | 85 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 43) | 70 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 202;N=45,38,46,38) | 50 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 22 | 32 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 202;N=45,38,46,38) | 50 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 387;N=45,38,46,38) | 22 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Baseline) | 9 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 22) | 37 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 387;N=46,37,38,36) | 27 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 43 | 68 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 43 | 98 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Baseline) | 15 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 22) | 86 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 22 | 80 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 43) | 100 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 202;N=45,38,46,38) | 100 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 202;N=45,38,46,38) | 91 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 387;N=46,37,38,36) | 84 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 387;N=45,38,46,38) | 76 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 202;N=45,38,46,38) | 39 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 43) | 81 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 22 | 44 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 387;N=45,38,46,38) | 25 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 387;N=46,37,38,36) | 36 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 22) | 50 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Day 202;N=45,38,46,38) | 55 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses After the First and Second Vaccinations | Seroconversion Day 43 | 76 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses After the First and Second Vaccinations | HI titer ≥1:40 (Baseline) | 19 Percentages of Subjects |
Primary
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
Time frame: Day 1 to 7
Population: The analysis was done on the safety set which included the five subjects who received wrong vaccination according to the randomization. These five subjects were excluded from PPS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Change in eating habits | 21 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Fever≥38.5°C | 5 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Vomiting | 13 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Ecchymosis | 0 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Irritability | 40 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Swelling | 6 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Induration | 8 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Erythema | 1 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Persist crying | 34 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Tenderness | 49 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Sleepiness | 36 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Diarrhea | 32 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Erythema | 0 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Diarrhea | 28 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Induration | 8 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Irritability | 39 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Change in eating habits | 16 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Vomiting | 10 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Ecchymosis | 0 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Sleepiness | 28 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Tenderness | 42 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Swelling | 9 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Fever≥38.5°C | 5 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Persist crying | 35 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Vomiting | 12 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Ecchymosis | 0 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Erythema | 2 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Swelling | 4 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Induration | 13 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Tenderness | 53 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Sleepiness | 38 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Diarrhea | 37 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Irritability | 45 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Change in eating habits | 19 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Persist crying | 35 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Fever≥38.5°C | 9 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Sleepiness | 30 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Tenderness | 42 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Ecchymosis | 0 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Change in eating habits | 18 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Induration | 8 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Swelling | 6 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Fever≥38.5°C | 7 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Persist crying | 35 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Vomiting | 10 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Diarrhea | 25 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Erythema | 1 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Irritability | 41 Participants |
Primary
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.
Time frame: Day 22 to 28
Population: The analysis was done on the safety set. Almost all the subjects across the vaccine groups received their first and second vaccinations within the protocol-specified window. While all the enrolled subjects received their first vaccination, 3% to 7% of subjects across the vaccine groups did not receive their second vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Change in eating habits | 20 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Fever≥38.5°C | 8 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Vomiting | 11 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Ecchymosis | 0 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Irritability | 36 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Swelling | 2 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Induration | 4 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Erythema | 1 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Persist crying | 21 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Tenderness | 35 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Sleepiness | 28 Participants |
| 3.75_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Diarrhea | 20 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Erythema | 1 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Diarrhea | 19 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Induration | 3 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Irritability | 39 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Change in eating habits | 18 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Vomiting | 9 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Ecchymosis | 0 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Sleepiness | 21 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Tenderness | 27 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Swelling | 1 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Fever≥38.5°C | 5 Participants |
| 7.5_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Persist crying | 22 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Vomiting | 14 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Ecchymosis | 1 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Erythema | 4 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Swelling | 8 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Induration | 12 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Tenderness | 37 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Sleepiness | 20 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Diarrhea | 20 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Irritability | 32 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Change in eating habits | 14 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Persist crying | 24 Participants |
| 7.5_(50)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Fever≥38.5°C | 4 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Sleepiness | 17 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Tenderness | 32 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Ecchymosis | 0 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Change in eating habits | 11 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Induration | 9 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Swelling | 6 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Fever≥38.5°C | 7 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Persist crying | 18 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Vomiting | 5 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Diarrhea | 15 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Erythema | 1 Participants |
| 15_(0)MF59 | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Irritability | 24 Participants |
Secondary
Antibody Persistence by Geometric Mean Titers (GMT)
Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.
Time frame: 6 months (Day 202) and 12 months (Day 387) after second vaccination
Population: The analysis was done on the subgroup of the per-protocol set (PPS).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 3.75_(50)MF59 | Antibody Persistence by Geometric Mean Titers (GMT) | GMT (Day 1) | 10 Titer |
| 3.75_(50)MF59 | Antibody Persistence by Geometric Mean Titers (GMT) | GMT (Day 387, N= 46, 37, 38, 36) | 92 Titer |
| 3.75_(50)MF59 | Antibody Persistence by Geometric Mean Titers (GMT) | GMT (Day 202, N=45, 38, 46, 38) | 176 Titer |
| 7.5_(0)MF59 | Antibody Persistence by Geometric Mean Titers (GMT) | GMT (Day 1) | 7.27 Titer |
| 7.5_(0)MF59 | Antibody Persistence by Geometric Mean Titers (GMT) | GMT (Day 387, N= 46, 37, 38, 36) | 15 Titer |
| 7.5_(0)MF59 | Antibody Persistence by Geometric Mean Titers (GMT) | GMT (Day 202, N=45, 38, 46, 38) | 33 Titer |
| 7.5_(50)MF59 | Antibody Persistence by Geometric Mean Titers (GMT) | GMT (Day 202, N=45, 38, 46, 38) | 205 Titer |
| 7.5_(50)MF59 | Antibody Persistence by Geometric Mean Titers (GMT) | GMT (Day 1) | 9.29 Titer |
| 7.5_(50)MF59 | Antibody Persistence by Geometric Mean Titers (GMT) | GMT (Day 387, N= 46, 37, 38, 36) | 85 Titer |
| 15_(0)MF59 | Antibody Persistence by Geometric Mean Titers (GMT) | GMT (Day 1) | 11 Titer |
| 15_(0)MF59 | Antibody Persistence by Geometric Mean Titers (GMT) | GMT (Day 387, N= 46, 37, 38, 36) | 25 Titer |
| 15_(0)MF59 | Antibody Persistence by Geometric Mean Titers (GMT) | GMT (Day 202, N=45, 38, 46, 38) | 42 Titer |
Secondary
Antibody Response Based on Baseline Seropositivity
Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10
Time frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Population: The analysis was done on the subgroup of the per-protocol set (PPS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1) | 72 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22) | 72 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43) | 100 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1) | 0 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1) | 100 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22) | 31 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1) | 67 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1) | 31 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43) | 67 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1) | 0 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43) | 100 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22) | 82 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1) | 82 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1) | 0 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1) | 100 Percentages of Subjects |
| 15_(0)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1) | 39 Percentages of Subjects |
| 15_(0)MF59 | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1) | 77 Percentages of Subjects |
| 15_(0)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22) | 39 Percentages of Subjects |
| 15_(0)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1) | 0 Percentages of Subjects |
| 15_(0)MF59 | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43) | 77 Percentages of Subjects |
| 3.75_(50)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1) | 62 Percentages of Subjects |
| 3.75_(50)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1) | 77 Percentages of Subjects |
| 3.75_(50)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43) | 100 Percentages of Subjects |
| 3.75_(50)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22) | 95 Percentages of Subjects |
| 3.75_(50)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1) | 92 Percentages of Subjects |
| 7.5_(0)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1) | 39 Percentages of Subjects |
| 7.5_(0)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1) | 36 Percentages of Subjects |
| 7.5_(0)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1) | 71 Percentages of Subjects |
| 7.5_(0)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22) | 57 Percentages of Subjects |
| 7.5_(0)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43) | 82 Percentages of Subjects |
| 7.5_(50) MF59-Previous Vaccinaiton | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22) | 94 Percentages of Subjects |
| 7.5_(50) MF59-Previous Vaccinaiton | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1) | 54 Percentages of Subjects |
| 7.5_(50) MF59-Previous Vaccinaiton | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1) | 94 Percentages of Subjects |
| 7.5_(50) MF59-Previous Vaccinaiton | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1) | 74 Percentages of Subjects |
| 7.5_(50) MF59-Previous Vaccinaiton | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43) | 100 Percentages of Subjects |
| 15_(0)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 22/Day 1) | 56 Percentages of Subjects |
| 15_(0)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 22) | 74 Percentages of Subjects |
| 15_(0)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 1) | 64 Percentages of Subjects |
| 15_(0)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | Seroconversion (Day 43/Day 1) | 74 Percentages of Subjects |
| 15_(0)MF59-Previous Vaccination | Antibody Response Based on Baseline Seropositivity | HI titer ≥1:40 (Day 43) | 92 Percentages of Subjects |
Secondary
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
Time frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Population: The analysis was done on the subgroup of the per-protocol set(PPS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 22/Day 1) | 73 Percentages 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) | 100 Percentages 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) | 78 Percentages 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) | 25 Percentages of Subjects |
| 3.75_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 43/Day 1) | 99 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 43/Day 1) | 66 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 22) | 42 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 43) | 67 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 1) | 12 Percentages of Subjects |
| 7.5_(0)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 22/Day 1) | 37 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 43/Day 1) | 98 Percentages 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) | 100 Percentages of Subjects |
| 7.5_(50)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 22/Day 1) | 78 Percentages 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) | 84 Percentages 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) | 16 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 1) | 21 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 43) | 83 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 22/Day 1) | 44 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 43/Day 1) | 78 Percentages of Subjects |
| 15_(0)MF59 | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 22) | 49 Percentages of Subjects |
| 3.75_(50)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 1) | 8 Percentages of Subjects |
| 3.75_(50)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 22/Day 1) | 75 Percentages of Subjects |
| 3.75_(50)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 43/Day 1) | 96 Percentages of Subjects |
| 3.75_(50)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 22) | 81 Percentages of Subjects |
| 3.75_(50)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 43) | 100 Percentages of Subjects |
| 7.5_(0)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 1) | 2 Percentages of Subjects |
| 7.5_(0)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 22) | 27 Percentages of Subjects |
| 7.5_(0)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 43/Day 1) | 71 Percentages of Subjects |
| 7.5_(0)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 22/Day 1) | 22 Percentages of Subjects |
| 7.5_(0)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 43) | 76 Percentages of Subjects |
| 7.5_(50) MF59-Previous Vaccinaiton | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 1) | 12 Percentages of Subjects |
| 7.5_(50) MF59-Previous Vaccinaiton | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 22/Day 1) | 85 Percentages of Subjects |
| 7.5_(50) MF59-Previous Vaccinaiton | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 43/Day 1) | 100 Percentages of Subjects |
| 7.5_(50) MF59-Previous Vaccinaiton | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 43) | 100 Percentages of Subjects |
| 7.5_(50) MF59-Previous Vaccinaiton | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 22) | 91 Percentages of Subjects |
| 15_(0)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 43) | 78 Percentages of Subjects |
| 15_(0)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 22) | 50 Percentages of Subjects |
| 15_(0)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 22/Day 1) | 45 Percentages of Subjects |
| 15_(0)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | HI titer ≥1:40 (Day 1) | 15 Percentages of Subjects |
| 15_(0)MF59-Previous Vaccination | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Seroconversion (Day 43/Day 1) | 73 Percentages of Subjects |
Secondary
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10 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 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Population: The analysis was done on the subgroup of the per-protocol set (PPS).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 1 | 5.06 Titres |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 43 | 566 Titres |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 22 | 42 Titres |
| 7.5_(0)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 43 | 65 Titres |
| 7.5_(0)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 22 | 15 Titres |
| 7.5_(0)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 1 | 5.07 Titres |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 43 | 577 Titres |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 1 | 5.01 Titres |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 22 | 60 Titres |
| 15_(0)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 1 | 5.06 Titres |
| 15_(0)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 22 | 17 Titres |
| 15_(0)MF59 | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 43 | 96 Titres |
| 3.75_(50)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 22 | 266 Titres |
| 3.75_(50)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 1 | 53 Titres |
| 3.75_(50)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 43 | 660 Titres |
| 7.5_(0)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 22 | 67 Titres |
| 7.5_(0)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 1 | 35 Titres |
| 7.5_(0)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 43 | 167 Titres |
| 7.5_(50) MF59-Previous Vaccinaiton | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 22 | 313 Titres |
| 7.5_(50) MF59-Previous Vaccinaiton | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 1 | 47 Titres |
| 7.5_(50) MF59-Previous Vaccinaiton | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 43 | 811 Titres |
| 15_(0)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 1 | 69 Titres |
| 15_(0)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 22 | 248 Titres |
| 15_(0)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Day 43 | 420 Titres |
Secondary
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
Time frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Population: The analysis was done on the subgroup on the per-protocol set (PPS).
| 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 1 | 11 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43 | 975 Titers |
| 3.75_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22 | 101 Titers |
| 7.5_(0)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43 | 103 Titers |
| 7.5_(0)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22 | 25 Titers |
| 7.5_(0)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1 | 7.95 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43 | 788 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1 | 9.94 Titers |
| 7.5_(50)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22 | 105 Titers |
| 15_(0)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1 | 12 Titers |
| 15_(0)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22 | 42 Titers |
| 15_(0)MF59 | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43 | 186 Titers |
| 3.75_(50)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22 | 80 Titers |
| 3.75_(50)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1 | 10 Titers |
| 3.75_(50)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43 | 389 Titers |
| 7.5_(0)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22 | 17 Titers |
| 7.5_(0)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1 | 6.52 Titers |
| 7.5_(0)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43 | 57 Titers |
| 7.5_(50) MF59-Previous Vaccinaiton | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22 | 100 Titers |
| 7.5_(50) MF59-Previous Vaccinaiton | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1 | 8.30 Titers |
| 7.5_(50) MF59-Previous Vaccinaiton | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43 | 483 Titers |
| 15_(0)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 1 | 10 Titers |
| 15_(0)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 22 | 45 Titers |
| 15_(0)MF59-Previous Vaccination | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Day 43 | 124 Titers |
Secondary
Immunogenicity Measurement by Geometric Mean Titers (GMT)
Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.
Time frame: 21 days after each vaccination
Population: The analysis was done on the Full Analysis Set (FAS).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 3.75_(50)MF59 | Immunogenicity Measurement by Geometric Mean Titers (GMT) | GMT Baseline | 10 Titers |
| 3.75_(50)MF59 | Immunogenicity Measurement by Geometric Mean Titers (GMT) | GMT Day 43 | 642 Titers |
| 3.75_(50)MF59 | Immunogenicity Measurement by Geometric Mean Titers (GMT) | GMT Day 22 | 83 Titers |
| 7.5_(0)MF59 | Immunogenicity Measurement by Geometric Mean Titers (GMT) | GMT Baseline | 7.27 Titers |
| 7.5_(0)MF59 | Immunogenicity Measurement by Geometric Mean Titers (GMT) | GMT Day 43 | 80 Titers |
| 7.5_(0)MF59 | Immunogenicity Measurement by Geometric Mean Titers (GMT) | GMT Day 22 | 20 Titers |
| 7.5_(50)MF59 | Immunogenicity Measurement by Geometric Mean Titers (GMT) | GMT Day 22 | 92 Titers |
| 7.5_(50)MF59 | Immunogenicity Measurement by Geometric Mean Titers (GMT) | GMT Baseline | 9.29 Titers |
| 7.5_(50)MF59 | Immunogenicity Measurement by Geometric Mean Titers (GMT) | GMT Day 43 | 626 Titers |
| 15_(0)MF59 | Immunogenicity Measurement by Geometric Mean Titers (GMT) | GMT Baseline | 11 Titers |
| 15_(0)MF59 | Immunogenicity Measurement by Geometric Mean Titers (GMT) | GMT Day 43 | 151 Titers |
| 15_(0)MF59 | Immunogenicity Measurement by Geometric Mean Titers (GMT) | GMT Day 22 | 37 Titers |
95% CI: [2.55, 6.46]
95% CI: [1.42, 3.56]
95% CI: [2.8, 7.19]
95% CI: [1.56, 3.96]
95% CI: [5.52, 12]
95% CI: [2.94, 6.15]
95% CI: [5.36, 11]
95% CI: [2.86, 6.02]
Comparison: Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 2295% CI: [2.37, 5.65]
Comparison: Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.95% CI: [1.43, 3.4]
Comparison: Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.95% CI: [2.85, 6.86]
Comparison: Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.95% CI: [1.72, 4.13]
Comparison: Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.95% CI: [5.54, 11]
Comparison: Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines95% CI: [3.23, 6.42]
Comparison: Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.95% CI: [5.3, 11]
Comparison: Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.95% CI: [3.09, 6.19]