Trial Outcomes & Findings for Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects (NCT NCT01342796)

Last Updated: 2021-04-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

Day 1, Day 50

Results posted on

2021-04-19

Participant Flow

Subjects were recruited from two sites in Belgium.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	aTIV Group Subjects received two doses (0.25mL) of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart.	TIV Group Subjects received two doses (0.25mL) of inactivated, subunit influenza vaccine administered four weeks apart.
Overall Study STARTED	43	41
Overall Study COMPLETED	40	38
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	aTIV Group Subjects received two doses (0.25mL) of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart.	TIV Group Subjects received two doses (0.25mL) of inactivated, subunit influenza vaccine administered four weeks apart.
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	0	3
Overall Study Inappropriate enrollment	1	0

Baseline Characteristics

Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	aTIV Group n=43 Participants Subjects received two doses (0.25mL) of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart.	TIV Group n=41 Participants Subjects received two doses (0.25mL) of inactivated, subunit influenza vaccine administered four weeks apart.	Total n=84 Participants Total of all reporting groups
Age, Continuous	20.2 years STANDARD_DEVIATION 8.5 • n=5 Participants	21.4 years STANDARD_DEVIATION 9.7 • n=7 Participants	20.8 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, Day 50

Population: Per Protocol Set

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.

Outcome measures

Outcome measures
Measure	aTIV Group n=25 Participants Subjects received two doses of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart.	TIV Group n=31 Participants Subjects received two doses of inactivated, subunit influenza vaccine administered four weeks apart.
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 Interval 639.0 to 1852.0	1368 Cells per Million Total Cells Interval 914.0 to 1822.0
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 Interval 759.0 to 1565.0	1229 Cells per Million Total Cells Interval 928.0 to 1531.0
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 Interval 207.0 to 359.0	240 Cells per Million Total Cells Interval 165.0 to 315.0
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 Interval 477.0 to 784.0	655 Cells per Million Total Cells Interval 503.0 to 806.0
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 Interval 1244.0 to 1876.0	1137 Cells per Million Total Cells Interval 826.0 to 1449.0
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 Interval 346.0 to 660.0	462 Cells per Million Total Cells Interval 322.0 to 602.0
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 Interval 1105.0 to 1550.0	671 Cells per Million Total Cells Interval 474.0 to 869.0
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 Interval 452.0 to 844.0	753 Cells per Million Total Cells Interval 579.0 to 927.0
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 Interval 1940.0 to 2798.0	1062 Cells per Million Total Cells Interval 677.0 to 1446.0
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 Interval 215.0 to 996.0	749 Cells per Million Total Cells Interval 483.0 to 1015.0
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 Interval 1113.0 to 2100.0	996 Cells per Million Total Cells Interval 662.0 to 1330.0
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 Interval 55913.0 to 98182.0	107200 Cells per Million Total Cells Interval 91682.0 to 122719.0
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 Interval 56864.0 to 103935.0	105013 Cells per Million Total Cells Interval 88270.0 to 121755.0
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 Interval 858.0 to 1423.0	642 Cells per Million Total Cells Interval 366.0 to 918.0
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 Interval 140.0 to 283.0	184 Cells per Million Total Cells Interval 121.0 to 248.0
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 Interval 723.0 to 1126.0	387 Cells per Million Total Cells Interval 208.0 to 566.0
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 Interval 183.0 to 419.0	330 Cells per Million Total Cells Interval 225.0 to 435.0
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 Interval 1321.0 to 2087.0	610 Cells per Million Total Cells Interval 267.0 to 954.0
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 Interval 119.0 to 632.0	275 Cells per Million Total Cells Interval 100.0 to 449.0
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 Interval 691.0 to 1497.0	541 Cells per Million Total Cells Interval 268.0 to 813.0
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 Interval 47735.0 to 87313.0	93312 Cells per Million Total Cells Interval 78781.0 to 107843.0
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 Interval 46682.0 to 88033.0	92489 Cells per Million Total Cells Interval 77768.0 to 107210.0
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 Interval 309.0 to 899.0	672 Cells per Million Total Cells Interval 451.0 to 892.0
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 Interval 291.0 to 1027.0	765 Cells per Million Total Cells Interval 489.0 to 1041.0
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 Interval 49.0 to 135.0	116 Cells per Million Total Cells Interval 73.0 to 158.0
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 Interval 163.0 to 350.0	248 Cells per Million Total Cells Interval 156.0 to 340.0
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 Interval 44.0 to 112.0	78 Cells per Million Total Cells Interval 48.0 to 108.0
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 Interval 113.0 to 268.0	130 Cells per Million Total Cells Interval 61.0 to 199.0
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 Interval 37.0 to 130.0	122 Cells per Million Total Cells Interval 81.0 to 163.0
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 Interval 201.0 to 462.0	106 Cells per Million Total Cells Interval -12.1 to 224.0
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 Interval 46.0 to 179.0	94 Cells per Million Total Cells Interval 49.0 to 139.0
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 Interval 67.0 to 320.0	145 Cells per Million Total Cells Interval 59.0 to 230.0
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 Interval 2110.0 to 5120.0	4780 Cells per Million Total Cells Interval 3675.0 to 5885.0
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 Interval 2367.0 to 5349.0	4519 Cells per Million Total Cells Interval 3390.0 to 5649.0
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 Interval 64.0 to 248.0	148 Cells per Million Total Cells Interval 80.0 to 217.0
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 Interval 4.0 to 144.0	163 Cells per Million Total Cells Interval 10.0 to 215.0
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 Interval 87.0 to 170.0	133 Cells per Million Total Cells Interval 92.0 to 174.0
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 Interval 368.0 to 621.0	290 Cells per Million Total Cells Interval 165.0 to 415.0
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 Interval 56.0 to 106.0	69 Cells per Million Total Cells Interval 46.0 to 91.0
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 Interval 324.0 to 571.0	202 Cells per Million Total Cells Interval 93.0 to 311.0
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 Interval 62.0 to 170.0	152 Cells per Million Total Cells Interval 104.0 to 200.0
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 Interval 658.0 to 1184.0	251 Cells per Million Total Cells Interval 13.0 to 490.0
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 Interval 50.0 to 249.0	171 Cells per Million Total Cells Interval 103.0 to 238.0
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 Interval 372.0 to 857.0	244 Cells per Million Total Cells Interval 77.0 to 410.0
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 Interval 15528.0 to 35406.0	37856 Cells per Million Total Cells Interval 30559.0 to 45154.0
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 Interval 22453.0 to 42566.0	34805 Cells per Million Total Cells Interval 27557.0 to 42054.0
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 Interval 278.0 to 795.0	541 Cells per Million Total Cells Interval 348.0 to 735.0
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 Interval 156.0 to 612.0	644 Cells per Million Total Cells Interval 473.0 to 815.0
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 Interval 132.0 to 332.0	170 Cells per Million Total Cells Interval 71.0 to 268.0
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 Interval 105.0 to 378.0	347 Cells per Million Total Cells Interval 212.0 to 483.0
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 Interval 154.0 to 346.0	174 Cells per Million Total Cells Interval 89.0 to 259.0
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 Interval 229.0 to 494.0	231 Cells per Million Total Cells Interval 114.0 to 348.0
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 Interval 59.0 to 308.0	168 Cells per Million Total Cells Interval 57.0 to 278.0
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 Interval 228.0 to 463.0	221 Cells per Million Total Cells Interval 116.0 to 326.0
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 Interval -27.62 to 329.0	88 Cells per Million Total Cells Interval -33.78 to 209.0
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 Interval 18.0 to 175.0	93 Cells per Million Total Cells Interval 39.0 to 146.0
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 Interval 547.0 to 1487.0	950 Cells per Million Total Cells Interval 605.0 to 1295.0
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 Interval 391.0 to 1153.0	993 Cells per Million Total Cells Interval 714.0 to 1272.0
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 Interval -0.845 to 333.0	222 Cells per Million Total Cells Interval 98.0 to 347.0
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 Interval -21.88 to 516.0	293 Cells per Million Total Cells Interval 94.0 to 491.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	aTIV Group n=43 Participants Subjects received two doses of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart.	TIV Group n=41 Participants Subjects received two doses of inactivated, subunit influenza vaccine administered four weeks apart.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV AE leading to discontinuation	0 Participants	0 Participants
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV Death	0 Participants	0 Participants
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV Any Adverse Event (AE)	20 Participants	18 Participants
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV At least possibly related AE	1 Participants	3 Participants
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV Any SAE	0 Participants	2 Participants
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV At least possibly related SAE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 50

Population: Per Protocol Set

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%.

Outcome measures

Outcome measures
Measure	aTIV Group n=25 Participants Subjects received two doses of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart.	TIV Group n=30 Participants Subjects received two doses of inactivated, subunit influenza vaccine administered four weeks apart.
Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer A/H1N1/California	100 Percentage of participants Interval 86.0 to 100.0	73 Percentage of participants Interval 54.0 to 88.0
Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer A/H3N2/Victoria	100 Percentage of participants Interval 86.0 to 100.0	93 Percentage of participants Interval 78.0 to 99.0
Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer B/Brisbane	100 Percentage of participants Interval 86.0 to 100.0	53 Percentage of participants Interval 34.0 to 72.0

SECONDARY outcome

Timeframe: Day 50/Day 1

Population: Per Protocol Set

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.

Outcome measures

Outcome measures
Measure	aTIV Group n=25 Participants Subjects received two doses of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart.	TIV Group n=30 Participants Subjects received two doses of inactivated, subunit influenza vaccine administered four weeks apart.
Geometric Mean Ratios (GMR) A/H1N1/California	41 titer ratio Interval 23.0 to 74.0	9.99 titer ratio Interval 5.87 to 17.0
Geometric Mean Ratios (GMR) A/H3N2/Victoria	199 titer ratio Interval 130.0 to 303.0	35 titer ratio Interval 24.0 to 51.0
Geometric Mean Ratios (GMR) B/Brisbane	34 titer ratio Interval 22.0 to 52.0	5.63 titer ratio Interval 3.83 to 8.29

SECONDARY outcome

Timeframe: 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%

Outcome measures

Outcome measures
Measure	aTIV Group n=25 Participants Subjects received two doses of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart.	TIV Group n=30 Participants Subjects received two doses of inactivated, subunit influenza vaccine administered four weeks apart.
Percentage of Subjects With HI Titers >1:40 A/H3N2/Victoria	100 Percentage of participants Interval 86.0 to 100.0	97 Percentage of participants Interval 83.0 to 100.0
Percentage of Subjects With HI Titers >1:40 A/H1N1/California	100 Percentage of participants Interval 86.0 to 100.0	93 Percentage of participants Interval 78.0 to 99.0
Percentage of Subjects With HI Titers >1:40 B/Brisbane	100 Percentage of participants Interval 86.0 to 100.0	57 Percentage of participants Interval 37.0 to 75.0

Adverse Events

aTIV (6 to <36 Months)

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

TIV (6 to <36 Months)

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	aTIV (6 to <36 Months) n=43 participants at risk	TIV (6 to <36 Months) n=41 participants at risk
Infections and infestations Varicella	0.00% 0/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	2.4% 1/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
Infections and infestations Pneumonia	0.00% 0/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	2.4% 1/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.

Other adverse events

Other adverse events
Measure	aTIV (6 to <36 Months) n=43 participants at risk	TIV (6 to <36 Months) n=41 participants at risk
Nervous system disorders Somnolence	25.6% 11/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	29.3% 12/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
General disorders Crying	14.0% 6/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	17.1% 7/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
General disorders Injection site erythema	18.6% 8/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	4.9% 2/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
General disorders Injection site haemorrhage	9.3% 4/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	2.4% 1/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
General disorders Injection site induration	7.0% 3/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	7.3% 3/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
General disorders Injection site pain	25.6% 11/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	22.0% 9/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
General disorders Pyrexia	44.2% 19/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	36.6% 15/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
General disorders Nasopharyngitis	11.6% 5/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	9.8% 4/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
General disorders Bronchitis	7.0% 3/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	2.4% 1/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
Psychiatric disorders Eating Disorder	25.6% 11/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	26.8% 11/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
Psychiatric disorders Irratability	25.6% 11/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	17.1% 7/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
Gastrointestinal disorders Diarrhoea	25.6% 11/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	26.8% 11/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
Gastrointestinal disorders Vomiting	7.0% 3/43 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.	12.2% 5/41 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60