Human Influenza, Influenza, Influenza Due to Unspecified Influenza Virus, Seasonal Influenza
Conditions
Keywords
Cell mediated immunity, cell mediated immune response, Children, adjuvanted
Brief summary
This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated children aged 6 to \<36 months.
Interventions
BIOLOGICALMF59C.1-adjuvanted subunit influenza vaccine
2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
BIOLOGICALSub unit, Inactivated, Influenza vaccine
2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
Yes
Inclusion criteria
* Male and female previously unvaccinated healthy children aged 6 to \<36 months.
Exclusion criteria
* Any known or suspected impairment of the immune system, any serious disease. * Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study. * Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Day 1, Day 50 | The CMI responses were determined by intracellular staining/Fluorescence-Activated Cell Sorting(ICS/FACS) after in-vitro restimulation of PBMC with vaccine antigens on day 0 and day 50. |
| Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | Day 1 to Day 50 post vaccination | The number of subjects reporting unsolicited AEs between Day 1 and the study termination i.e., Day 50, after receiving two doses of aTIV and TIV. Data are reported based on the Safety Set. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer | Day 50 | To evaluate the immune responses by seroconversion of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to \< 36 months for all three strains. Criteron: The proportion of subjects achieving seroconversion or significant increase in HI titer should be \> 40%. |
| Geometric Mean Ratios (GMR) | Day 50/Day 1 | To evaluate the immune responses by mean geometric increase (GMR) of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to \< 36 months for all three strains. Criterion: Mean geometric increase (GMR) should be \> 2.5. |
| Percentage of Subjects With HI Titers >1:40 | Day 50 | To evaluate the immune responses by proportion of subjects with HI titers \>1:40 of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to \< 36 months for all three strains. Criterion: The proportion of subjects with HI titers \>1:40 should be \> 70% |
Countries
Belgium
Participant flow
Recruitment details
Subjects were recruited from two sites in Belgium.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| aTIV Group Subjects received two doses (0.25mL) of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart. | 43 |
| TIV Group Subjects received two doses (0.25mL) of inactivated, subunit influenza vaccine administered four weeks apart. | 41 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inappropriate enrollment | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | aTIV Group | TIV Group | Total |
|---|---|---|---|
| Age, Continuous | 20.2 years STANDARD_DEVIATION 8.5 | 21.4 years STANDARD_DEVIATION 9.7 | 20.8 years STANDARD_DEVIATION 9.1 |
| Sex: Female, Male Female | 20 Participants | 14 Participants | 34 Participants |
| Sex: Female, Male Male | 23 Participants | 27 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 37 / 43 | 29 / 41 |
| serious Total, serious adverse events | 0 / 43 | 2 / 41 |
Outcome results
Primary
Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination.
The CMI responses were determined by intracellular staining/Fluorescence-Activated Cell Sorting(ICS/FACS) after in-vitro restimulation of PBMC with vaccine antigens on day 0 and day 50.
Time frame: Day 1, Day 50
Population: Per Protocol Set
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - B/Florida, Day 1 | 112 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - B/Florida, Day 50 | 1094 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - A/H3N2, Day 50 | 1328 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - SEB, Day 1 | 67524 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - A/H3N2, Day 50 | 191 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - SEB, Day 50 | 67357 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - B/Brisbane, (N=19, 24), Day 1 | 648 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - Tetanus toxoid, Day 1 | 604 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α-Tetanus toxoid, Day 1 | 537 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - Tetanus toxoid, Day 50 | 659 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - B/Brisbane, Day 50 | 2369 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - A/H1N1, Day 50 | 257 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - Tetanus toxoid, Day 50 | 74 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - A/H3N2, Day 1 | 78 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ -B/Brisbane, Day 1 | 83 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any cytokine - B/Florida, Day 1 | 605 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ -B/Brisbane, Day 50 | 331 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - A/H3N2, Day 50 | 361 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - B/Florida, Day 50 | 193 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any cytokine - B/Florida, Day 50 | 1607 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - SEB, Day 1 | 3615 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 -SEB, Day 1 | 1017 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - SEB, Day 50 | 3858 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - SEB, Day 1 | 77048 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - Tetanus toxoid, Day 1 | 156 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α - A/H3N2, Day 1 | 81 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - A/H1N1, Day 1 | 92 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α - A/H3N2, Day 50 | 447 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any cytokine -Tetanus toxoid, Day 1 | 1246 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α - B/Brisbane, Day 1 | 116 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 -SEB, Day 50 | 772 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α - B/Brisbane, Day 50 | 921 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any cytokine -Tetanus toxoid, Day 50 | 1162 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α - B/Florida, Day 1 | 149 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α- A/H1N1, Day 1 | 128 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α - B/Florida, Day 50 | 614 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2- A/H1N1, Day 1 | 283 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α-SEB, Day 1 | 25467 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 -Tetanus toxoid, Day 1 | 166 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α-SEB, Day 50 | 32510 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2- A/H1N1, Day 50 | 1141 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α-Tetanus toxoid, Day 50 | 384 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - A/H1N1, Day 1 | 631 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - A/H1N1, Day 1 | 232 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - A/H3N2, Day 1 | 212 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - A/H1N1, Day 50 | 242 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - SEB, Day 50 | 80400 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - A/H3N2, Day 1 | 250 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - A/H3N2, Day 50 | 925 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - B/Brisbane, Day 1 | 184 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - A/H1N1, Day 50 | 1560 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - B/Brisbane, Day 50 | 346 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2- B/Brisbane, Day 1 | 301 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - B/Florida, Day 1 | 150 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α- A/H1N1, Day 50 | 495 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - B/Florida, Day 50 | 97 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2- B/Brisbane, Day 50 | 1704 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - A/H3N2, Day 1 | 503 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 -Tetanus toxoid, Day 50 | 247 Cells per Million Total Cells |
| aTIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - B/Florida, Day 1 | 375 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 -Tetanus toxoid, Day 50 | 293 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - Tetanus toxoid, Day 50 | 765 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - A/H3N2, Day 1 | 78 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - A/H3N2, Day 50 | 130 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ -B/Brisbane, Day 50 | 106 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - Tetanus toxoid, Day 1 | 148 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - Tetanus toxoid, Day 50 | 163 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α- A/H1N1, Day 1 | 133 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α- A/H1N1, Day 50 | 290 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α-SEB, Day 50 | 34805 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - A/H3N2, Day 1 | 174 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 -SEB, Day 1 | 950 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 -SEB, Day 50 | 993 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - A/H1N1, Day 1 | 655 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - A/H1N1, Day 50 | 1137 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - A/H3N2, Day 1 | 462 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - A/H3N2, Day 50 | 671 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - B/Brisbane, (N=19, 24), Day 1 | 753 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - B/Brisbane, Day 50 | 1062 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any cytokine - B/Florida, Day 1 | 749 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any cytokine - B/Florida, Day 50 | 996 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - SEB, Day 50 | 105013 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any cytokine -Tetanus toxoid, Day 1 | 1368 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any cytokine -Tetanus toxoid, Day 50 | 1229 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2- A/H1N1, Day 1 | 240 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2- A/H1N1, Day 50 | 642 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - A/H3N2, Day 1 | 184 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - A/H3N2, Day 50 | 387 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2- B/Brisbane, Day 1 | 330 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2- B/Brisbane, Day 50 | 610 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - B/Florida, Day 1 | 275 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - B/Florida, Day 50 | 541 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - SEB, Day 1 | 93312 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - SEB, Day 50 | 92489 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-2 - Tetanus toxoid, Day 1 | 672 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - A/H1N1, Day 1 | 116 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - A/H1N1, Day 50 | 248 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ -B/Brisbane, Day 1 | 122 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - B/Florida, Day 1 | 94 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - B/Florida, Day 50 | 145 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - SEB, Day 1 | 4780 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IFN-γ - SEB, Day 50 | 4519 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α - A/H3N2, Day 1 | 69 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α - A/H3N2, Day 50 | 202 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α - B/Brisbane, Day 1 | 152 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α - B/Brisbane, Day 50 | 251 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α - B/Florida, Day 1 | 171 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α - B/Florida, Day 50 | 244 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α-SEB, Day 1 | 37856 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α-Tetanus toxoid, Day 1 | 541 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | TNF-α-Tetanus toxoid, Day 50 | 644 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - A/H1N1, Day 1 | 170 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - A/H1N1, Day 50 | 347 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - A/H3N2, Day 50 | 231 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - B/Brisbane, Day 1 | 168 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - B/Brisbane, Day 50 | 221 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - B/Florida, Day 1 | 88 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 - B/Florida, Day 50 | 93 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | IL-13 -Tetanus toxoid, Day 1 | 222 Cells per Million Total Cells |
| TIV Group | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | Any Cytokine - SEB, Day 1 | 107200 Cells per Million Total Cells |
Primary
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV
The number of subjects reporting unsolicited AEs between Day 1 and the study termination i.e., Day 50, after receiving two doses of aTIV and TIV. Data are reported based on the Safety Set.
Time frame: Day 1 to Day 50 post vaccination
Population: All subjects in the Exposed Set (all enrolled subjects who actually received a study vaccine) who provided post-baseline safety data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| aTIV Group | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | AE leading to discontinuation | 0 Participants |
| aTIV Group | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | Any SAE | 0 Participants |
| aTIV Group | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | Death | 0 Participants |
| aTIV Group | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | Any Adverse Event (AE) | 20 Participants |
| aTIV Group | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | At least possibly related AE | 1 Participants |
| aTIV Group | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | At least possibly related SAE | 0 Participants |
| TIV Group | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | At least possibly related AE | 3 Participants |
| TIV Group | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | Any Adverse Event (AE) | 18 Participants |
| TIV Group | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | Any SAE | 2 Participants |
| TIV Group | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | AE leading to discontinuation | 0 Participants |
| TIV Group | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | At least possibly related SAE | 0 Participants |
| TIV Group | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | Death | 0 Participants |
Secondary
Geometric Mean Ratios (GMR)
To evaluate the immune responses by mean geometric increase (GMR) of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to \< 36 months for all three strains. Criterion: Mean geometric increase (GMR) should be \> 2.5.
Time frame: Day 50/Day 1
Population: Per Protocol Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aTIV Group | Geometric Mean Ratios (GMR) | A/H1N1/California | 41 titer ratio |
| aTIV Group | Geometric Mean Ratios (GMR) | A/H3N2/Victoria | 199 titer ratio |
| aTIV Group | Geometric Mean Ratios (GMR) | B/Brisbane | 34 titer ratio |
| TIV Group | Geometric Mean Ratios (GMR) | A/H1N1/California | 9.99 titer ratio |
| TIV Group | Geometric Mean Ratios (GMR) | A/H3N2/Victoria | 35 titer ratio |
| TIV Group | Geometric Mean Ratios (GMR) | B/Brisbane | 5.63 titer ratio |
Secondary
Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer
To evaluate the immune responses by seroconversion of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to \< 36 months for all three strains. Criteron: The proportion of subjects achieving seroconversion or significant increase in HI titer should be \> 40%.
Time frame: Day 50
Population: Per Protocol Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aTIV Group | Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer | A/H1N1/California | 100 Percentage of participants |
| aTIV Group | Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer | A/H3N2/Victoria | 100 Percentage of participants |
| aTIV Group | Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer | B/Brisbane | 100 Percentage of participants |
| TIV Group | Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer | A/H1N1/California | 73 Percentage of participants |
| TIV Group | Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer | A/H3N2/Victoria | 93 Percentage of participants |
| TIV Group | Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer | B/Brisbane | 53 Percentage of participants |
Secondary
Percentage of Subjects With HI Titers >1:40
To evaluate the immune responses by proportion of subjects with HI titers \>1:40 of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to \< 36 months for all three strains. Criterion: The proportion of subjects with HI titers \>1:40 should be \> 70%
Time frame: Day 50
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aTIV Group | Percentage of Subjects With HI Titers >1:40 | B/Brisbane | 100 Percentage of participants |
| aTIV Group | Percentage of Subjects With HI Titers >1:40 | A/H1N1/California | 100 Percentage of participants |
| aTIV Group | Percentage of Subjects With HI Titers >1:40 | A/H3N2/Victoria | 100 Percentage of participants |
| TIV Group | Percentage of Subjects With HI Titers >1:40 | A/H3N2/Victoria | 97 Percentage of participants |
| TIV Group | Percentage of Subjects With HI Titers >1:40 | A/H1N1/California | 93 Percentage of participants |
| TIV Group | Percentage of Subjects With HI Titers >1:40 | B/Brisbane | 57 Percentage of participants |