Trial Outcomes & Findings for A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults (NCT NCT02115815)
NCT ID: NCT02115815
Last Updated: 2016-10-21
Results Overview
Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever greater than or equal to (\>=) 100.4 degrees F by any route from Day 1 to Day 7.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
246 participants
Primary outcome timeframe
Day 1 to Day 7
Results posted on
2016-10-21
Participant Flow
A total of 246 subjects were screened. Of these, 146 subjects were enrolled.
A total of 146 participants were enrolled in the study. Of the 146 randomized participants, 2 participants did not receive investigational product. 144 participants were included in the As-treated Population.
Participant milestones
| Measure |
Placebo
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
20
|
20
|
20
|
20
|
22
|
20
|
|
Overall Study
COMPLETED
|
22
|
20
|
20
|
20
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Not enough drug to dose participant
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Missed appointment, randomized in error
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=24 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=20 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.6 Years
STANDARD_DEVIATION 7.6 • n=113 Participants
|
66.5 Years
STANDARD_DEVIATION 6.0 • n=163 Participants
|
66.6 Years
STANDARD_DEVIATION 4.1 • n=160 Participants
|
69.3 Years
STANDARD_DEVIATION 5.6 • n=483 Participants
|
70.5 Years
STANDARD_DEVIATION 6.1 • n=36 Participants
|
70.0 Years
STANDARD_DEVIATION 7.0 • n=10 Participants
|
69.4 Years
STANDARD_DEVIATION 7.0 • n=115 Participants
|
68.7 Years
STANDARD_DEVIATION 6.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=113 Participants
|
9 Participants
n=163 Participants
|
9 Participants
n=160 Participants
|
10 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
68 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=113 Participants
|
11 Participants
n=163 Participants
|
11 Participants
n=160 Participants
|
10 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
76 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: As-treated Population (ATP) included participants who received any study investigational product.
Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever greater than or equal to (\>=) 100.4 degrees F by any route from Day 1 to Day 7.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=20 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Symptoms
|
6 participants
|
4 participants
|
15 participants
|
7 participants
|
14 participants
|
9 participants
|
17 participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 28Population: As-treated Population (ATP) included participants who received any study investigational product.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=20 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
5 participants
|
3 participants
|
5 participants
|
8 participants
|
2 participants
|
4 participants
|
5 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 361Population: As-treated Population (ATP) included participants who received any study investigational product.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state. 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. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving investigational product and was assessed by investigator as medically significant.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=20 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)
TEAESIs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)
TESAEs
|
2 participants
|
0 participants
|
0 participants
|
5 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)
NOCDs
|
2 participants
|
0 participants
|
0 participants
|
4 participants
|
1 participants
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361Population: Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, "n" is number of participants analysed for this outcome measure at give time points.
RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=20 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Baseline (n= 24, 20, 20, 20, 20, 20, 20)
|
441.37 titer
Interval 293.36 to 664.05
|
362.67 titer
Interval 252.96 to 519.95
|
367.73 titer
Interval 220.44 to 613.44
|
448.36 titer
Interval 282.62 to 711.28
|
442.03 titer
Interval 294.25 to 664.02
|
491.31 titer
Interval 327.84 to 736.3
|
428.16 titer
Interval 334.37 to 548.25
|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 29 (n= 24, 20, 20, 20, 19, 19, 20)
|
430.04 titer
Interval 285.59 to 647.56
|
619.09 titer
Interval 419.12 to 914.45
|
809.84 titer
Interval 611.36 to 1072.77
|
981.61 titer
Interval 695.95 to 1384.51
|
1182.72 titer
Interval 813.02 to 1720.53
|
1116.48 titer
Interval 813.79 to 1531.74
|
1405.14 titer
Interval 1079.32 to 1829.32
|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 61 (n= 24, 20, 20, 20, 20, 20, 20)
|
513.18 titer
Interval 339.82 to 775.0
|
716.09 titer
Interval 455.53 to 1125.7
|
764.04 titer
Interval 563.35 to 1036.21
|
959.74 titer
Interval 693.89 to 1327.44
|
1092.18 titer
Interval 769.39 to 1550.4
|
945.22 titer
Interval 732.16 to 1220.28
|
1046.60 titer
Interval 802.46 to 1365.04
|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 181 (n= 23, 19, 20, 19, 20, 18, 20)
|
373.79 titer
Interval 238.19 to 586.6
|
419.68 titer
Interval 281.38 to 625.97
|
421.09 titer
Interval 276.97 to 640.22
|
548.95 titer
Interval 372.94 to 808.01
|
487.07 titer
Interval 328.42 to 722.38
|
761.54 titer
Interval 558.06 to 1039.21
|
614.39 titer
Interval 435.55 to 866.66
|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 271 (n= 20, 20, 20, 19, 20, 17, 19)
|
485.89 titer
Interval 325.78 to 724.69
|
600.28 titer
Interval 441.76 to 815.7
|
589.97 titer
Interval 418.92 to 830.86
|
829.32 titer
Interval 592.46 to 1160.89
|
710.41 titer
Interval 498.88 to 1011.61
|
705.14 titer
Interval 522.45 to 951.71
|
560.89 titer
Interval 360.47 to 872.76
|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 361 (n= 18, 0, 0, 0, 0, 17, 19)
|
491.90 titer
Interval 313.9 to 770.85
|
NA titer
No participants were evaluated.
|
NA titer
No participants were evaluated.
|
NA titer
No participants were evaluated.
|
NA titer
No participants were evaluated.
|
675.04 titer
Interval 503.39 to 905.21
|
483.15 titer
Interval 360.07 to 648.3
|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 91 (n= 23, 20, 20, 19, 20, 19, 20)
|
535.19 titer
Interval 350.79 to 816.54
|
635.83 titer
Interval 417.05 to 969.37
|
641.14 titer
Interval 464.88 to 884.24
|
849.22 titer
Interval 582.14 to 1238.85
|
1013.06 titer
Interval 700.41 to 1465.27
|
834.48 titer
Interval 626.96 to 1110.69
|
992.21 titer
Interval 799.35 to 1231.6
|
SECONDARY outcome
Timeframe: Day 29, 61, 91, 181, 271 and 361Population: Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, "n" is number of participants analysed for this outcome measure at give time points.
RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=20 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 29 (n= 24, 20, 20, 20, 19, 19, 20)
|
0.97 fold rise
Interval 0.89 to 1.07
|
1.71 fold rise
Interval 1.34 to 2.17
|
2.20 fold rise
Interval 1.43 to 3.39
|
2.19 fold rise
Interval 1.52 to 3.15
|
2.53 fold rise
Interval 1.85 to 3.46
|
2.51 fold rise
Interval 1.74 to 3.62
|
3.28 fold rise
Interval 2.51 to 4.29
|
|
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 91 (n= 23, 20, 20, 19, 20, 19, 20)
|
1.18 fold rise
Interval 0.99 to 1.39
|
1.75 fold rise
Interval 1.4 to 2.2
|
1.74 fold rise
Interval 1.14 to 2.67
|
2.01 fold rise
Interval 1.38 to 2.92
|
2.29 fold rise
Interval 1.65 to 3.18
|
1.72 fold rise
Interval 1.18 to 2.51
|
2.32 fold rise
Interval 1.82 to 2.95
|
|
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 271 (n= 20, 20, 20, 19, 20, 17, 19)
|
0.87 fold rise
Interval 0.76 to 0.99
|
1.66 fold rise
Interval 1.38 to 1.98
|
1.60 fold rise
Interval 1.02 to 2.53
|
1.96 fold rise
Interval 1.5 to 2.56
|
1.61 fold rise
Interval 1.29 to 2.0
|
1.38 fold rise
Interval 0.9 to 2.09
|
1.32 fold rise
Interval 0.89 to 1.95
|
|
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 61 (n= 24, 20, 20, 20, 20, 20, 20)
|
1.16 fold rise
Interval 0.95 to 1.42
|
1.97 fold rise
Interval 1.5 to 2.6
|
2.08 fold rise
Interval 1.33 to 3.25
|
2.14 fold rise
Interval 1.46 to 3.14
|
2.47 fold rise
Interval 1.74 to 3.51
|
1.92 fold rise
Interval 1.32 to 2.8
|
2.44 fold rise
Interval 1.88 to 3.18
|
|
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 181 (n= 23, 19, 20, 19, 20, 18, 20)
|
0.82 fold rise
Interval 0.72 to 0.94
|
1.13 fold rise
Interval 0.93 to 1.38
|
1.15 fold rise
Interval 0.69 to 1.9
|
1.30 fold rise
Interval 0.96 to 1.75
|
1.10 fold rise
Interval 0.89 to 1.37
|
1.50 fold rise
Interval 0.96 to 2.33
|
1.43 fold rise
Interval 1.1 to 1.87
|
|
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 361 (n= 7, 0, 0, 0, 0, 17, 19)
|
0.73 fold rise
Interval 0.58 to 0.91
|
NA fold rise
No participant was evaluated.
|
NA fold rise
No participant was evaluated.
|
NA fold rise
No participant was evaluated.
|
NA fold rise
No participant was evaluated.
|
1.32 fold rise
Interval 0.87 to 2.01
|
1.14 fold rise
Interval 0.91 to 1.42
|
SECONDARY outcome
Timeframe: Day 29Population: Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.
Seroresponse defined as a greater than or equal to (\>=) 4-fold rise from baseline.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=19 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=19 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
|
0 percentage of participants
Interval 0.0 to 14.25
|
10.0 percentage of participants
Interval 1.23 to 31.7
|
5.0 percentage of participants
Interval 0.13 to 24.87
|
5.0 percentage of participants
Interval 0.13 to 24.87
|
10.5 percentage of participants
Interval 1.3 to 33.14
|
26.3 percentage of participants
Interval 9.15 to 51.2
|
25.0 percentage of participants
Interval 8.66 to 49.1
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361Population: Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, "n" is number of participants analysed for this outcome measure at give time points.
Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=20 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Baseline (n= 24, 20, 20, 20, 20, 20, 20)
|
64.89 titer
Interval 46.32 to 90.9
|
45.24 titer
Interval 30.89 to 66.26
|
64.94 titer
Interval 44.56 to 94.63
|
82.73 titer
Interval 44.45 to 153.97
|
93.51 titer
Interval 61.85 to 141.38
|
76.61 titer
Interval 45.39 to 129.29
|
73.84 titer
Interval 48.14 to 113.25
|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 91 (n= 22, 20, 20, 19, 20, 19, 20)
|
71.57 titer
Interval 51.15 to 100.14
|
305.06 titer
Interval 184.64 to 504.02
|
365.38 titer
Interval 256.55 to 520.39
|
587.79 titer
Interval 376.03 to 918.81
|
704.64 titer
Interval 478.1 to 1038.52
|
596.80 titer
Interval 385.76 to 923.3
|
928.58 titer
Interval 675.84 to 1275.84
|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 181 (n= 23, 19, 20, 19, 20, 18, 20)
|
68.41 titer
Interval 49.68 to 94.19
|
211.75 titer
Interval 134.85 to 332.5
|
235.81 titer
Interval 163.36 to 340.38
|
405.25 titer
Interval 252.75 to 649.78
|
456.76 titer
Interval 311.64 to 669.46
|
463.64 titer
Interval 311.06 to 691.06
|
604.90 titer
Interval 429.19 to 852.54
|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 271 (n= 20, 20, 20, 19, 20, 17, 19)
|
78.65 titer
Interval 59.58 to 103.82
|
170.78 titer
Interval 116.92 to 249.46
|
196.53 titer
Interval 136.9 to 282.13
|
332.98 titer
Interval 209.95 to 528.11
|
358.67 titer
Interval 245.43 to 524.16
|
376.48 titer
Interval 256.43 to 552.75
|
364.40 titer
Interval 212.16 to 625.87
|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 29 (n= 24, 20, 20, 20, 20, 19, 20)
|
66.16 titer
Interval 47.46 to 92.24
|
364.83 titer
Interval 214.31 to 621.05
|
658.97 titer
Interval 460.21 to 943.58
|
998.28 titer
Interval 636.44 to 1565.84
|
1159.03 titer
Interval 773.42 to 1736.89
|
924.44 titer
Interval 598.78 to 1427.22
|
1552.03 titer
Interval 1162.56 to 2071.99
|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 61 (n= 24, 20, 20, 20, 20, 20, 20)
|
71.76 titer
Interval 53.17 to 96.85
|
351.98 titer
Interval 208.53 to 594.11
|
454.40 titer
Interval 316.95 to 651.45
|
738.48 titer
Interval 481.62 to 1132.34
|
875.86 titer
Interval 609.86 to 1257.88
|
731.83 titer
Interval 478.07 to 1120.28
|
1136.41 titer
Interval 834.01 to 1548.47
|
|
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 361 (n= 18, 19, 20, 19, 20, 17, 19)
|
73.17 titer
Interval 53.72 to 99.68
|
159.37 titer
Interval 110.5 to 229.87
|
186.26 titer
Interval 129.59 to 267.7
|
309.01 titer
Interval 196.87 to 485.03
|
298.08 titer
Interval 203.83 to 435.91
|
351.12 titer
Interval 245.76 to 501.67
|
374.98 titer
Interval 272.66 to 515.69
|
SECONDARY outcome
Timeframe: Day 29, 61, 91, 181, 271 and 361Population: Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, "n" is number of participants analysed for this outcome measure at give time points.
Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=20 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 29 (n= 24, 20, 20, 20, 20, 19, 20)
|
1.02 fold rise
Interval 0.98 to 1.06
|
8.06 fold rise
Interval 4.51 to 14.41
|
10.15 fold rise
Interval 6.91 to 14.91
|
12.07 fold rise
Interval 6.29 to 23.14
|
12.39 fold rise
Interval 8.2 to 18.74
|
13.21 fold rise
Interval 7.59 to 22.99
|
21.02 fold rise
Interval 14.42 to 30.64
|
|
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 271 (n= 20, 20, 20, 19, 20, 17, 19)
|
1.04 fold rise
Interval 0.94 to 1.15
|
3.77 fold rise
Interval 2.54 to 5.6
|
3.03 fold rise
Interval 2.19 to 4.19
|
4.46 fold rise
Interval 2.48 to 8.02
|
3.84 fold rise
Interval 2.92 to 5.03
|
4.14 fold rise
Interval 2.4 to 7.12
|
5.12 fold rise
Interval 3.31 to 7.93
|
|
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 61 (n= 24, 20, 20, 20, 20, 20, 20)
|
1.11 fold rise
Interval 1.02 to 1.2
|
7.78 fold rise
Interval 4.4 to 13.75
|
7.00 fold rise
Interval 4.79 to 10.22
|
8.93 fold rise
Interval 4.63 to 17.22
|
9.37 fold rise
Interval 6.53 to 13.43
|
9.55 fold rise
Interval 5.48 to 16.67
|
15.39 fold rise
Interval 10.7 to 22.14
|
|
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 91 (n= 22, 20, 20, 19, 20, 19, 20)
|
1.11 fold rise
Interval 1.01 to 1.22
|
6.74 fold rise
Interval 3.96 to 11.47
|
5.63 fold rise
Interval 3.92 to 8.08
|
7.87 fold rise
Interval 4.16 to 14.89
|
7.54 fold rise
Interval 5.28 to 10.75
|
7.84 fold rise
Interval 4.43 to 13.86
|
12.58 fold rise
Interval 8.88 to 17.8
|
|
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 181 (n= 23, 19, 20, 19, 20, 18, 20)
|
1.08 fold rise
Interval 0.99 to 1.18
|
4.84 fold rise
Interval 3.11 to 7.55
|
3.63 fold rise
Interval 2.59 to 5.09
|
5.42 fold rise
Interval 2.86 to 10.29
|
4.88 fold rise
Interval 3.56 to 6.71
|
5.43 fold rise
Interval 3.12 to 9.43
|
8.19 fold rise
Interval 5.78 to 11.61
|
|
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 361 (n= 18, 19, 20, 19, 20, 17, 19)
|
1.05 fold rise
Interval 0.93 to 1.2
|
3.56 fold rise
Interval 2.42 to 5.23
|
2.87 fold rise
Interval 2.11 to 3.9
|
4.14 fold rise
Interval 2.4 to 7.14
|
3.19 fold rise
Interval 2.46 to 4.13
|
3.86 fold rise
Interval 2.27 to 6.57
|
5.27 fold rise
Interval 3.8 to 7.31
|
SECONDARY outcome
Timeframe: Day 29Population: Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.
Seroresponse defined as a greater than or equal to (\>=) 4-fold rise from baseline.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=19 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
|
0 percentage of participants
Interval 0.0 to 14.25
|
65.0 percentage of participants
Interval 40.78 to 84.61
|
90.0 percentage of participants
Interval 68.3 to 98.77
|
80.0 percentage of participants
Interval 56.34 to 94.27
|
90.0 percentage of participants
Interval 68.3 to 98.77
|
84.2 percentage of participants
Interval 60.42 to 96.62
|
100.0 percentage of participants
Interval 83.16 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 8 and 29Population: Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, "N" and 'n' is number of participants analysed for this outcome measure and at given time points, respectively.
The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=19 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)
Baseline (n= 22, 16, 18, 19, 18, 20, 20)
|
47.17 spot forming counts per 10^6 PBMCs
Interval 38.28 to 58.14
|
41.59 spot forming counts per 10^6 PBMCs
Interval 33.25 to 52.02
|
35.95 spot forming counts per 10^6 PBMCs
Interval 31.13 to 41.52
|
39.81 spot forming counts per 10^6 PBMCs
Interval 33.39 to 47.46
|
48.44 spot forming counts per 10^6 PBMCs
Interval 38.9 to 60.31
|
37.78 spot forming counts per 10^6 PBMCs
Interval 34.0 to 41.98
|
38.43 spot forming counts per 10^6 PBMCs
Interval 33.51 to 44.07
|
|
Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)
Day 8 (n= 20, 20, 18, 17, 18, 15, 19)
|
41.01 spot forming counts per 10^6 PBMCs
Interval 34.29 to 49.05
|
62.63 spot forming counts per 10^6 PBMCs
Interval 45.02 to 87.15
|
88.72 spot forming counts per 10^6 PBMCs
Interval 53.16 to 148.06
|
80.25 spot forming counts per 10^6 PBMCs
Interval 54.7 to 117.74
|
115.88 spot forming counts per 10^6 PBMCs
Interval 66.23 to 202.76
|
88.59 spot forming counts per 10^6 PBMCs
Interval 51.63 to 152.01
|
310.22 spot forming counts per 10^6 PBMCs
Interval 179.1 to 537.34
|
|
Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)
Day 29 (n= 23, 16, 20, 19, 20, 19, 14)
|
40.91 spot forming counts per 10^6 PBMCs
Interval 32.9 to 50.88
|
39.93 spot forming counts per 10^6 PBMCs
Interval 33.04 to 48.25
|
60.30 spot forming counts per 10^6 PBMCs
Interval 42.19 to 86.19
|
69.36 spot forming counts per 10^6 PBMCs
Interval 48.95 to 98.29
|
91.15 spot forming counts per 10^6 PBMCs
Interval 60.37 to 137.62
|
77.13 spot forming counts per 10^6 PBMCs
Interval 52.38 to 113.56
|
54.74 spot forming counts per 10^6 PBMCs
Interval 33.43 to 89.64
|
SECONDARY outcome
Timeframe: Day 8 and 29Population: Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, "N" and 'n' is number of participants analysed for this outcome measure and at given time points, respectively.
The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=16 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=18 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=19 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=18 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=20 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)
Day 8 (n= 20, 20, 18, 17, 18, 15, 19)
|
0.90 fold rise
Interval 0.78 to 1.04
|
1.57 fold rise
Interval 1.1 to 2.24
|
2.18 fold rise
Interval 1.37 to 3.49
|
2.01 fold rise
Interval 1.29 to 3.12
|
2.21 fold rise
Interval 1.28 to 3.8
|
2.45 fold rise
Interval 1.46 to 4.1
|
8.01 fold rise
Interval 4.74 to 13.53
|
|
Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)
Day 29 (n= 23, 16, 20, 19, 20, 19, 14)
|
0.88 fold rise
Interval 0.72 to 1.06
|
0.91 fold rise
Interval 0.77 to 1.07
|
1.54 fold rise
Interval 1.11 to 2.13
|
1.80 fold rise
Interval 1.25 to 2.58
|
1.99 fold rise
Interval 1.26 to 3.15
|
2.10 fold rise
Interval 1.47 to 2.99
|
1.36 fold rise
Interval 0.84 to 2.19
|
SECONDARY outcome
Timeframe: Day 8Population: Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.
Seroresponse defined as a greater than or equal to (\>=) 3-fold rise from baseline
Outcome measures
| Measure |
Placebo
n=20 Participants
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 Participants
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=18 Participants
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=17 Participants
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=18 Participants
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=15 Participants
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=19 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8
|
0 percentage of participants
Interval 0.0 to 17.65
|
12.5 percentage of participants
Interval 1.55 to 38.35
|
18.8 percentage of participants
Interval 4.05 to 45.65
|
25.0 percentage of participants
Interval 7.27 to 52.38
|
35.3 percentage of participants
Interval 14.21 to 61.67
|
46.7 percentage of participants
Interval 21.27 to 73.41
|
73.7 percentage of participants
Interval 48.8 to 90.85
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
RSV sF 20 Microgram (mcg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI7510 20 Microgram (mcg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
RSV sF 50 Microgram (mcg)
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
MEDI7510 50 Microgram (mcg)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
RSV sF 80 Microgram (mcg)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
MEDI7510 80 Microgram (mcg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=24 participants at risk
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 participants at risk
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 participants at risk
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 participants at risk
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=20 participants at risk
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=20 participants at risk
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 participants at risk
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
General disorders
Chest pain
|
4.2%
1/24 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Infections and infestations
Postoperative wound infection
|
4.2%
1/24 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Infections and infestations
Sepsis
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
4.2%
1/24 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
Other adverse events
| Measure |
Placebo
n=24 participants at risk
Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
|
RSV sF 20 Microgram (mcg)
n=20 participants at risk
Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 20 Microgram (mcg)
n=20 participants at risk
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 50 Microgram (mcg)
n=20 participants at risk
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 50 Microgram (mcg)
n=20 participants at risk
Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
RSV sF 80 Microgram (mcg)
n=20 participants at risk
Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
|
MEDI7510 80 Microgram (mcg)
n=20 participants at risk
Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Ear and labyrinth disorders
Ear discomfort
|
4.2%
1/24 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
General disorders
Fatigue
|
4.2%
1/24 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
General disorders
Injection site pain
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 2 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
10.0%
2/20 • Number of events 2 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.2%
1/24 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
1/24 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
4.2%
1/24 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Renal and urinary disorders
Haematuria
|
4.2%
1/24 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
4.2%
1/24 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
4.2%
1/24 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
5.0%
1/20 • Number of events 1 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
0.00%
0/20 • AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER