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NCT02289820

A Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults

Completed Phase 1 Results posted Last updated 15 March 2018
What this trial tests

Phase 1 trial testing MEDI7510 in Respiratory Syncytial Virus (RSV) in 363 participants. Completed in 24 February 2016.

Timeline
5 January 2015
Primary endpoint
24 February 2016
24 February 2016

Quick facts

Lead sponsorMedImmune LLC
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment363
Start date5 January 2015
Primary completion24 February 2016
Estimated completion24 February 2016
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

MedImmune LLC — full company profile →

Who can join

Adults 60 to 99, any sex, with Respiratory Syncytial Virus (RSV). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Solicited Symptoms Primary · Day 1 to Day 7

Solicited symptoms are events that are considered likely to occur post dosing and included the local reaction (pain, tenderness or soreness, redness, and swelling at the site of injection) to investigational product (IP) injection and systemic symptoms (fever greater than or equal to \[\>=\] 100.4°F \[\>=38°C\] by any route, headache, generalized muscle aches, and fatigue or tiredness) that might be related to IP injection. Solicited symptoms were not coded using Medical Dictionary for Regulatory Activities (MedDRA) and summarized regardless of whether or not they are treatment emergent. The p

GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 135.9
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 273.7
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 260.0
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 460.0
Inactivated Influenza Vaccine (IIV)63.6
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 375.0
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 368.4
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Primary · From Day 1 to Day 29

An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent were the events between administration of study drug and including the follow-up period through Day 29. The AEs were summarized using the Medical Dictionary for Regulatory Activities version 18.1.

GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 15.1
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 215.4
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 222.5
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 430.0
Inactivated Influenza Vaccine (IIV)18.2
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 327.5
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 320.5
Percentage of Participants With Treatment-emergent Serious Adverse Events Primary · From Day 1 to Day 361

A serious adverse event (SAE) was an AE resulting in any of following reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk), persistent or significant disability/incapacity, congenital anomaly, and a medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.

GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 12.6
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 25.1
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 20
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 40
Inactivated Influenza Vaccine (IIV)2.3
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 30
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 32.6
Percentage of Participants With New Onset Chronic Diseases (NOCDs) Primary · From Day 1 to Day 361

A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. All NOCDs were recorded from the time of dosing through the day of the last participant contact (Day 361 visit).

GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 12.6
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 20
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 25.0
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 45.0
Inactivated Influenza Vaccine (IIV)0
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 30
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 30
Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI) Primary · From Day 1 to Day 361

An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. Treatment emergent AESIs were collected from the time of dosing through the day of the last participant contact (Day 361 visit).

GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 10
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 20
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 20
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 40
Inactivated Influenza Vaccine (IIV)0
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 32.5
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 30
Geometric Mean Titers (GMTs) of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay Secondary · Baseline (Day 1), Day 29, 61, 91, 181, 271, and 361

GMTs of serum antibodies against RSV, as assessed by the RSV A microneutralization assay at Baseline and the results through Day 361 were presented. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A. Immunogenicity population is defined as all participants in ATP who had no protocol deviation judged to have the potential to interfere with generation or interpretation of an immune response.

Baseline (Day 1)
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1441.15344.99 – 564.11
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2397.52279.60 – 565.17
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2401.85313.66 – 514.82
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4504.78332.66 – 765.95
Inactivated Influenza Vaccine (IIV)513.53414.42 – 636.36
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3365.19275.62 – 483.87
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3510.88416.00 – 627.40
Day 29
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 11068.43820.93 – 1390.57
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 21233.621010.37 – 1506.21
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 21004.49839.19 – 1202.36
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 41217.75867.21 – 1709.98
Inactivated Influenza Vaccine (IIV)464.13372.16 – 578.82
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3958.74792.78 – 1159.45
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 31370.551115.61 – 1683.75
Day 61
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 11168.56915.50 – 1491.57
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 41081.64750.47 – 1558.93
Inactivated Influenza Vaccine (IIV)626.09509.37 – 769.57
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3816.33676.78 – 984.64
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 31151.62939.64 – 1411.41
Day 91
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 11078.35839.60 – 1385.00
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4967.42665.58 – 1406.14
Inactivated Influenza Vaccine (IIV)579.56463.07 – 725.34
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3765.63642.61 – 912.20
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 31072.70854.84 – 1346.08
Day 181
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1866.23673.55 – 1114.04
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4763.51514.29 – 1133.49
Inactivated Influenza Vaccine (IIV)548.46439.44 – 684.53
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3631.44511.84 – 778.99
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3900.59716.04 – 1132.70
Day 271
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1796.48607.83 – 1043.70
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4579.19329.21 – 1018.98
Inactivated Influenza Vaccine (IIV)546.80435.46 – 686.62
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3565.08460.42 – 693.53
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3690.36552.52 – 862.59
Day 361
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1746.01594.45 – 936.22
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4814.32515.32 – 1286.80
Inactivated Influenza Vaccine (IIV)573.22458.58 – 716.51
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3533.55426.01 – 668.23
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3692.93554.05 – 866.62
Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by RSV A Microneutralization Assay Secondary · Day 29, 61, 91, 181, 271, and 361

GMFRs of serum antibodies against RSV, as assessed by the RSV A microneutralization assay from Baseline line through Day 361 were presented. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A.

Day 29
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 12.421.96 – 2.99
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 23.262.29 – 4.63
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 22.502.11 – 2.97
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 42.411.82 – 3.20
Inactivated Influenza Vaccine (IIV)0.920.86 – 0.97
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 32.632.17 – 3.18
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 32.642.12 – 3.30
Day 61
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 12.652.21 – 3.17
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 42.141.60 – 2.87
Inactivated Influenza Vaccine (IIV)1.241.08 – 1.42
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 32.241.81 – 2.76
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 32.201.79 – 2.70
Day 91
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 12.442.05 – 2.92
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 41.921.43 – 2.56
Inactivated Influenza Vaccine (IIV)1.141.04 – 1.25
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 32.101.70 – 2.59
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 32.071.65 – 2.59
Day 181
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 11.991.72 – 2.30
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 41.511.20 – 1.91
Inactivated Influenza Vaccine (IIV)1.151.02 – 1.30
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 31.731.44 – 2.08
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 31.681.37 – 2.06
Day 271
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 11.831.57 – 2.14
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 41.080.64 – 1.81
Inactivated Influenza Vaccine (IIV)1.110.96 – 1.27
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 31.561.32 – 1.86
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 31.421.18 – 1.70
Day 361
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 11.711.50 – 1.96
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 41.471.12 – 1.93
Inactivated Influenza Vaccine (IIV)1.151.00 – 1.31
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 31.501.27 – 1.77
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 31.341.14 – 1.56
Percentage of Participants With Post-dose Seroresponse to RSV by RSV A Microneutralization Assay Secondary · Day 29

Seroresponse defined as a greater than or equal to (\>=) 3-fold rise in titer from baseline. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A.

GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 141.025.57 – 57.90
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 242.126.31 – 59.18
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 242.527.04 – 59.11
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 430.011.89 – 54.28
Inactivated Influenza Vaccine (IIV)00.00 – 8.22
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 335.020.63 – 51.68
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 340.524.75 – 57.90
Geometric Mean Concentrations of Serum Antibodies Against RSV by Anti F Immunoglobulin G (IgG) Assay Secondary · Baseline (Day 1), Day 29, 61, 91, 181, 271, and 361

Humoral immunogenicity samples were used to assess anti-F IgG antibodies measured using a 4-plex Meso Scale Discovery (MSD) platform assay. Results through Day 361 are presented.

Baseline (Day 1)
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 199.6374.22 – 133.73
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 295.2962.83 – 144.54
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2101.5175.45 – 136.58
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 467.9330.62 – 150.71
Inactivated Influenza Vaccine (IIV)92.3476.64 – 111.25
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 370.1855.27 – 89.11
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 382.1364.16 – 105.14
Day 29
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 11328.36958.76 – 1840.45
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 21433.981053.24 – 1952.34
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 21047.68810.79 – 1353.79
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 41003.07566.77 – 1775.23
Inactivated Influenza Vaccine (IIV)92.9476.81 – 112.46
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 31066.90836.10 – 1361.42
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 31474.471110.41 – 1957.90
Day 61
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 11050.29774.32 – 1424.61
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4852.27491.53 – 1477.76
Inactivated Influenza Vaccine (IIV)104.0080.54 – 134.30
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3850.91661.84 – 1093.99
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 31097.04816.40 – 1474.15
Day 91
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1817.05603.67 – 1105.86
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4662.15375.50 – 1167.62
Inactivated Influenza Vaccine (IIV)95.2977.73 – 116.82
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3705.96547.07 – 910.99
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3845.04636.42 – 1122.04
Day 181
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1501.47368.62 – 682.20
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4403.58226.56 – 718.92
Inactivated Influenza Vaccine (IIV)91.5474.62 – 112.29
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3466.81363.97 – 598.71
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3531.43398.10 – 709.41
Day 271
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1389.94286.92 – 529.96
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4341.99160.13 – 730.40
Inactivated Influenza Vaccine (IIV)92.7075.46 – 113.88
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3356.11276.99 – 457.84
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3423.30316.79 – 565.61
Day 361
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1343.64255.99 – 461.32
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4284.56140.69 – 575.55
Inactivated Influenza Vaccine (IIV)94.1074.03 – 119.61
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3305.10235.90 – 394.60
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3354.13268.29 – 467.43
GMFRs of Serum Antibodies Against RSV by Anti F IgG Assay Secondary · Day 29, 61, 91, 181, 271, and 361

The Anti F IgG antibodies were derived from the RSV-specific 4-plex MSD assay developed on the Meso Scale discovery platform. Humoral immunogenicity samples were used to assess anti-F IgG antibodies measured using a 4-plex Meso Scale Discovery (MSD) platform assay. Results through Day 361 are presented.

Day 29
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 113.339.39 – 18.93
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 215.1510.18 – 22.55
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 210.327.87 – 13.54
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 414.777.63 – 28.59
Inactivated Influenza Vaccine (IIV)0.990.96 – 1.02
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 315.2011.29 – 20.47
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 317.9514.06 – 22.91
Day 61
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 110.547.73 – 14.37
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 412.556.55 – 24.04
Inactivated Influenza Vaccine (IIV)1.090.91 – 1.32
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 312.139.20 – 15.98
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 313.3510.51 – 16.96
Day 91
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 18.206.09 – 11.05
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 49.755.37 – 17.70
Inactivated Influenza Vaccine (IIV)1.000.95 – 1.05
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 310.067.74 – 13.07
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 310.288.18 – 12.94
Day 181
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 15.033.89 – 6.50
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 45.943.58 – 9.85
Inactivated Influenza Vaccine (IIV)0.970.92 – 1.02
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 36.655.23 – 8.47
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 36.235.01 – 7.74
Day 271
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 13.913.05 – 5.02
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 44.923.11 – 7.77
Inactivated Influenza Vaccine (IIV)0.960.91 – 1.01
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 35.144.09 – 6.44
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 34.753.76 – 5.99
Day 361
GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 13.452.74 – 4.33
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 44.222.61 – 6.80
Inactivated Influenza Vaccine (IIV)0.960.91 – 1.02
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 34.473.55 – 5.65
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 34.073.29 – 5.03
Percentage of Participants With Post-dose Seroresponse to RSV by Anti-F IgG Assay Secondary · Day 29

Seroresponse defined as a greater than or equal to (\>=) 3-fold rise from baseline. Humoral immunity against RSV was assessed by an Anti-F IgG assay derived from the RSV-specific 4-plex MSD assay.

GroupValue95% CI
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 194.982.68 – 99.37
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 289.575.20 – 97.06
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 290.076.34 – 97.21
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 485.062.11 – 96.79
Inactivated Influenza Vaccine (IIV)00.00 – 8.22
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 397.586.84 – 99.94
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 397.385.84 – 99.93
Ratios of GMTs and GMFRs of Hemagglutination Inhibition (HAI) Antibodies Secondary · Day 29

The ratio of post-dose HAI antibody GMTs and GMFRs in the IIV group and the MEDI7510 plus IIV group was provided by strain and by cohort for Cohorts 2 and 3 to check the effect of MEDI7510 on IIV when administered together. Humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed on Day 29 by each strain (H1N1, H3N2, B/Yamagata).

GMT: H1N1
GroupValue95% CI
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2NANA – NA
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 21.190.71 – 1.99
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3NANA – NA
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 31.010.63 – 1.61
GMT: H3N2
GroupValue95% CI
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2NANA – NA
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 21.531.03 – 2.28
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3NANA – NA
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 30.780.53 – 1.15
GMT: B/Yamagata
GroupValue95% CI
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2NANA – NA
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 21.380.81 – 2.36
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3NANA – NA
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 31.490.91 – 2.46
GMFR: H1N1
GroupValue95% CI
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2NANA – NA
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 21.130.68 – 1.87
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3NANA – NA
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 30.970.54 – 1.75
GMFR: H3N2
GroupValue95% CI
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2NANA – NA
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 21.530.86 – 2.72
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3NANA – NA
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 31.280.69 – 2.38
GMFR: B/Yamagata
GroupValue95% CI
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2NANA – NA
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 21.090.76 – 1.55
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3NANA – NA
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 31.000.71 – 1.40

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Serious: 1/39 (3%)
Deaths: —
Inactivated Influenza Vaccine (IIV)
Serious: 1/44 (2%)
Deaths: —
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Serious: 2/39 (5%)
Deaths: —
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Serious: 0/40 (0%)
Deaths: —
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Serious: 0/40 (0%)
Deaths: —
MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3
Serious: 1/39 (3%)
Deaths: —
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Serious: 0/20 (0%)
Deaths: —

Serious adverse events (5 terms)

ReactionSystemMEDI7510 (120 mcg sF + 1 m…Inactivated Influenza Vacc…MEDI7510 (120 mcg sF + 2.5…MEDI7510 (120 mcg sF + 2.5…MEDI7510 (120 mcg sF + 5 m…MEDI7510 (120 mcg sF + 5 m…MEDI7510 (80 mcg sF + 2.5 …
Cardiac arrestCardiac disorders———————
ArthralgiaMusculoskeletal and connective tissue disorders———————
Breast cancer femaleNeoplasms benign, malignant and unspecified (incl cysts and polyps)———————
Invasive ductal breast carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)———————
Rectal adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)———————
Other adverse events (54 terms — click to expand)

ReactionSystemMEDI7510 (120 mcg sF + 1 m…Inactivated Influenza Vacc…MEDI7510 (120 mcg sF + 2.5…MEDI7510 (120 mcg sF + 2.5…MEDI7510 (120 mcg sF + 5 m…MEDI7510 (120 mcg sF + 5 m…MEDI7510 (80 mcg sF + 2.5 …
Upper respiratory tract infectionInfections and infestations———————
Urinary tract infectionInfections and infestations———————
EcchymosisSkin and subcutaneous tissue disorders———————
ThrombocytopeniaBlood and lymphatic system disorders———————
Angina pectorisCardiac disorders———————
Coronary artery diseaseCardiac disorders———————
BlepharospasmEye disorders———————
IridocyclitisEye disorders———————
Abdominal pain lowerGastrointestinal disorders———————
Dental cariesGastrointestinal disorders———————
DiarrhoeaGastrointestinal disorders———————
Gastrooesophageal reflux diseaseGastrointestinal disorders———————
NauseaGastrointestinal disorders———————
Axillary painGeneral disorders———————
FatigueGeneral disorders———————
Injection site reactionGeneral disorders———————
PyrexiaGeneral disorders———————
CellulitisInfections and infestations———————
Gastroenteritis viralInfections and infestations———————
Herpes zosterInfections and infestations———————
LaryngitisInfections and infestations———————
NasopharyngitisInfections and infestations———————
Pharyngitis streptococcalInfections and infestations———————
RhinitisInfections and infestations———————
Viral upper respiratory tract infectionInfections and infestations———————
Bone contusionInjury, poisoning and procedural complications———————
FallInjury, poisoning and procedural complications———————
Humerus fractureInjury, poisoning and procedural complications———————
Post-traumatic painInjury, poisoning and procedural complications———————
Wound haematomaInjury, poisoning and procedural complications———————
Wrist fractureInjury, poisoning and procedural complications———————
HyperlipidaemiaMetabolism and nutrition disorders———————
HypoglycaemiaMetabolism and nutrition disorders———————
Back painMusculoskeletal and connective tissue disorders———————
Muscle spasmsMusculoskeletal and connective tissue disorders———————
Musculoskeletal chest painMusculoskeletal and connective tissue disorders———————
Musculoskeletal painMusculoskeletal and connective tissue disorders———————
MyalgiaMusculoskeletal and connective tissue disorders———————
Neck painMusculoskeletal and connective tissue disorders———————
Balance disorderNervous system disorders———————

Most-reported serious reactions: Cardiac arrest, Arthralgia, Breast cancer female, Invasive ductal breast carcinoma, Rectal adenocarcinoma.

Data from ClinicalTrials.gov NCT02289820 adverse events section.

Sponsor's own description

The goal of this study is to evaluate the safety, tolerability and immunogenicity of ascending doses of adjuvant in combination with a single dosage level of RSV sF in adults 60 years or older who are healthy or who have stable, chronic underlying medical conditions. This study will also provide preliminary safety and immunogenicity data to support concurrent dosing of MEDI7510 with influenza vaccine (IIV), and to assess the safety of MEDI7510 at a dose previously assessed in the Phase 1a study.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. An Adjuvanted, Postfusion F Protein-Based Vaccine Did Not Prevent Respiratory Syncytial Virus Illness in Older Adults.
    Falloon J, Yu J, Esser MT, Villafana T, et al · · 2017 · cited 109× · PMID 29029260 · DOI 10.1093/infdis/jix503
  2. The immunogenicity and safety of respiratory syncytial virus vaccines in development: A systematic review.
    Shan J, Britton PN, King CL, Booy R. · · 2021 · cited 47× · PMID 33764693 · DOI 10.1111/irv.12850
  3. A prefusion-stabilized RSV F subunit vaccine elicits B cell responses with greater breadth and potency than a postfusion F vaccine.
    Chang LA, Phung E, Crank MC, Morabito KM, et al · · 2022 · cited 41× · PMID 36542692 · DOI 10.1126/scitranslmed.ade0424
  4. Dose Selection for an Adjuvanted Respiratory Syncytial Virus F Protein Vaccine for Older Adults Based on Humoral and Cellular Immune Responses.
    Falloon J, Talbot HK, Curtis C, Ervin J, et al · · 2017 · cited 31× · PMID 28679495 · DOI 10.1128/cvi.00157-17
  5. Generalized ROC methods for immunogenicity data analysis of vaccine phase I studies in a seropositive population.
    Yu L, Esser MT, Falloon J, Villafana T, et al · · 2018 · cited 3× · PMID 29913105 · DOI 10.1080/21645515.2018.1489191
  6. Respiratory Syncytial Virus (RSV): A Comprehensive Overview From Basic Biology to Clinical Prevention and Control.
    Shi J, Huang X, Ye C, Lu Y, et al · · 2026 · PMID 41261734 · DOI 10.1002/med.70025

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02289820.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing