Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults (NCT NCT02289820)
NCT ID: NCT02289820
Last Updated: 2018-03-15
Results Overview
Solicited symptoms are events that are considered likely to occur post dosing and included the local reaction (pain, tenderness or soreness, redness, and swelling at the site of injection) to investigational product (IP) injection and systemic symptoms (fever greater than or equal to \[\>=\] 100.4°F \[\>=38°C\] by any route, headache, generalized muscle aches, and fatigue or tiredness) that might be related to IP injection. Solicited symptoms were not coded using Medical Dictionary for Regulatory Activities (MedDRA) and summarized regardless of whether or not they are treatment emergent. The percentage of participants with solicited symptoms were recorded during Days 1 (day of dosing) through 7.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
363 participants
Primary outcome timeframe
Day 1 to Day 7
Results posted on
2018-03-15
Participant Flow
A total of 363 participants were screened. Of these, 264 participants were enrolled.
A total of 264 participants were enrolled in the study. Of the 264 randomized participants, 3 participants did not receive the study drug. 261 participants were included in the As-treated Population.
Participant milestones
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
20
|
44
|
39
|
40
|
40
|
39
|
|
Overall Study
COMPLETED
|
37
|
18
|
38
|
37
|
40
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
6
|
2
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
2
|
1
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
1
|
0
|
1
|
1
|
|
Overall Study
withdrawal of consent
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults
Baseline characteristics by cohort
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Total
n=261 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.5 Years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
69.6 Years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
69.3 Years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
67.9 Years
STANDARD_DEVIATION 5.8 • n=4 Participants
|
70.1 Years
STANDARD_DEVIATION 5.9 • n=21 Participants
|
70.2 Years
STANDARD_DEVIATION 6.8 • n=10 Participants
|
68.9 Years
STANDARD_DEVIATION 6.5 • n=115 Participants
|
69.5 Years
STANDARD_DEVIATION 6.3 • n=6 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
142 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
119 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: As-treated Population (ATP) included all participants who received any amount of study drug.
Solicited symptoms are events that are considered likely to occur post dosing and included the local reaction (pain, tenderness or soreness, redness, and swelling at the site of injection) to investigational product (IP) injection and systemic symptoms (fever greater than or equal to \[\>=\] 100.4°F \[\>=38°C\] by any route, headache, generalized muscle aches, and fatigue or tiredness) that might be related to IP injection. Solicited symptoms were not coded using Medical Dictionary for Regulatory Activities (MedDRA) and summarized regardless of whether or not they are treatment emergent. The percentage of participants with solicited symptoms were recorded during Days 1 (day of dosing) through 7.
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=38 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=38 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Symptoms
|
35.9 Percentage of Participants
|
73.7 Percentage of Participants
|
60.0 Percentage of Participants
|
60.0 Percentage of Participants
|
63.6 Percentage of Participants
|
75.0 Percentage of Participants
|
68.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 29Population: ATP included all participants who received any amount of study drug.
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent were the events between administration of study drug and including the follow-up period through Day 29. The AEs were summarized using the Medical Dictionary for Regulatory Activities version 18.1.
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
5.1 Percentage of Participants
|
15.4 Percentage of Participants
|
22.5 Percentage of Participants
|
30.0 Percentage of Participants
|
18.2 Percentage of Participants
|
27.5 Percentage of Participants
|
20.5 Percentage of Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 361Population: ATP included all participants who received any amount of study drug.
A serious adverse event (SAE) was an AE resulting in any of following reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk), persistent or significant disability/incapacity, congenital anomaly, and a medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Serious Adverse Events
|
2.6 Percentage of Participants
|
5.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
2.3 Percentage of Participants
|
0 Percentage of Participants
|
2.6 Percentage of Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 361Population: ATP included all participants who received any amount of study drug.
A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. All NOCDs were recorded from the time of dosing through the day of the last participant contact (Day 361 visit).
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With New Onset Chronic Diseases (NOCDs)
|
2.6 Percentage of Participants
|
0 Percentage of Participants
|
5.0 Percentage of Participants
|
5.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 361Population: ATP included all participants who received any amount of study drug.
An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. Treatment emergent AESIs were collected from the time of dosing through the day of the last participant contact (Day 361 visit).
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
2.5 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 29, 61, 91, 181, 271, and 361Population: Immunogenicity population
GMTs of serum antibodies against RSV, as assessed by the RSV A microneutralization assay at Baseline and the results through Day 361 were presented. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A. Immunogenicity population is defined as all participants in ATP who had no protocol deviation judged to have the potential to interfere with generation or interpretation of an immune response.
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=38 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Baseline (Day 1)
|
441.15 Titers
Interval 344.99 to 564.11
|
397.52 Titers
Interval 279.6 to 565.17
|
401.85 Titers
Interval 313.66 to 514.82
|
504.78 Titers
Interval 332.66 to 765.95
|
513.53 Titers
Interval 414.42 to 636.36
|
365.19 Titers
Interval 275.62 to 483.87
|
510.88 Titers
Interval 416.0 to 627.4
|
|
Geometric Mean Titers (GMTs) of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 29
|
1068.43 Titers
Interval 820.93 to 1390.57
|
1233.62 Titers
Interval 1010.37 to 1506.21
|
1004.49 Titers
Interval 839.19 to 1202.36
|
1217.75 Titers
Interval 867.21 to 1709.98
|
464.13 Titers
Interval 372.16 to 578.82
|
958.74 Titers
Interval 792.78 to 1159.45
|
1370.55 Titers
Interval 1115.61 to 1683.75
|
|
Geometric Mean Titers (GMTs) of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 61
|
1168.56 Titers
Interval 915.5 to 1491.57
|
—
|
—
|
1081.64 Titers
Interval 750.47 to 1558.93
|
626.09 Titers
Interval 509.37 to 769.57
|
816.33 Titers
Interval 676.78 to 984.64
|
1151.62 Titers
Interval 939.64 to 1411.41
|
|
Geometric Mean Titers (GMTs) of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 91
|
1078.35 Titers
Interval 839.6 to 1385.0
|
—
|
—
|
967.42 Titers
Interval 665.58 to 1406.14
|
579.56 Titers
Interval 463.07 to 725.34
|
765.63 Titers
Interval 642.61 to 912.2
|
1072.70 Titers
Interval 854.84 to 1346.08
|
|
Geometric Mean Titers (GMTs) of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 181
|
866.23 Titers
Interval 673.55 to 1114.04
|
—
|
—
|
763.51 Titers
Interval 514.29 to 1133.49
|
548.46 Titers
Interval 439.44 to 684.53
|
631.44 Titers
Interval 511.84 to 778.99
|
900.59 Titers
Interval 716.04 to 1132.7
|
|
Geometric Mean Titers (GMTs) of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 271
|
796.48 Titers
Interval 607.83 to 1043.7
|
—
|
—
|
579.19 Titers
Interval 329.21 to 1018.98
|
546.80 Titers
Interval 435.46 to 686.62
|
565.08 Titers
Interval 460.42 to 693.53
|
690.36 Titers
Interval 552.52 to 862.59
|
|
Geometric Mean Titers (GMTs) of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 361
|
746.01 Titers
Interval 594.45 to 936.22
|
—
|
—
|
814.32 Titers
Interval 515.32 to 1286.8
|
573.22 Titers
Interval 458.58 to 716.51
|
533.55 Titers
Interval 426.01 to 668.23
|
692.93 Titers
Interval 554.05 to 866.62
|
SECONDARY outcome
Timeframe: Day 29, 61, 91, 181, 271, and 361Population: Immunogenicity Population. Here, 'n' is number of participants analyzed for this outcome measure at given time points.
GMFRs of serum antibodies against RSV, as assessed by the RSV A microneutralization assay from Baseline line through Day 361 were presented. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A.
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=38 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by RSV A Microneutralization Assay
Day 29
|
2.42 Fold rise
Interval 1.96 to 2.99
|
3.26 Fold rise
Interval 2.29 to 4.63
|
2.50 Fold rise
Interval 2.11 to 2.97
|
2.41 Fold rise
Interval 1.82 to 3.2
|
0.92 Fold rise
Interval 0.86 to 0.97
|
2.63 Fold rise
Interval 2.17 to 3.18
|
2.64 Fold rise
Interval 2.12 to 3.3
|
|
Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by RSV A Microneutralization Assay
Day 61
|
2.65 Fold rise
Interval 2.21 to 3.17
|
—
|
—
|
2.14 Fold rise
Interval 1.6 to 2.87
|
1.24 Fold rise
Interval 1.08 to 1.42
|
2.24 Fold rise
Interval 1.81 to 2.76
|
2.20 Fold rise
Interval 1.79 to 2.7
|
|
Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by RSV A Microneutralization Assay
Day 91
|
2.44 Fold rise
Interval 2.05 to 2.92
|
—
|
—
|
1.92 Fold rise
Interval 1.43 to 2.56
|
1.14 Fold rise
Interval 1.04 to 1.25
|
2.10 Fold rise
Interval 1.7 to 2.59
|
2.07 Fold rise
Interval 1.65 to 2.59
|
|
Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by RSV A Microneutralization Assay
Day 181
|
1.99 Fold rise
Interval 1.72 to 2.3
|
—
|
—
|
1.51 Fold rise
Interval 1.2 to 1.91
|
1.15 Fold rise
Interval 1.02 to 1.3
|
1.73 Fold rise
Interval 1.44 to 2.08
|
1.68 Fold rise
Interval 1.37 to 2.06
|
|
Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by RSV A Microneutralization Assay
Day 271
|
1.83 Fold rise
Interval 1.57 to 2.14
|
—
|
—
|
1.08 Fold rise
Interval 0.64 to 1.81
|
1.11 Fold rise
Interval 0.96 to 1.27
|
1.56 Fold rise
Interval 1.32 to 1.86
|
1.42 Fold rise
Interval 1.18 to 1.7
|
|
Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by RSV A Microneutralization Assay
Day 361
|
1.71 Fold rise
Interval 1.5 to 1.96
|
—
|
—
|
1.47 Fold rise
Interval 1.12 to 1.93
|
1.15 Fold rise
Interval 1.0 to 1.31
|
1.50 Fold rise
Interval 1.27 to 1.77
|
1.34 Fold rise
Interval 1.14 to 1.56
|
SECONDARY outcome
Timeframe: Day 29Population: Immunogenicity population.
Seroresponse defined as a greater than or equal to (\>=) 3-fold rise in titer from baseline. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A.
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=38 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Post-dose Seroresponse to RSV by RSV A Microneutralization Assay
|
41.0 Percentage of Participants
Interval 25.57 to 57.9
|
42.1 Percentage of Participants
Interval 26.31 to 59.18
|
42.5 Percentage of Participants
Interval 27.04 to 59.11
|
30.0 Percentage of Participants
Interval 11.89 to 54.28
|
0 Percentage of Participants
Interval 0.0 to 8.22
|
35.0 Percentage of Participants
Interval 20.63 to 51.68
|
40.5 Percentage of Participants
Interval 24.75 to 57.9
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 29, 61, 91, 181, 271, and 361Population: Immunogenicity Population. Here, 'n' is number of participants analyzed for this outcome measure at given time points.
Humoral immunogenicity samples were used to assess anti-F IgG antibodies measured using a 4-plex Meso Scale Discovery (MSD) platform assay. Results through Day 361 are presented.
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=38 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentrations of Serum Antibodies Against RSV by Anti F Immunoglobulin G (IgG) Assay
Baseline (Day 1)
|
99.63 F Ab Unit/mL
Interval 74.22 to 133.73
|
95.29 F Ab Unit/mL
Interval 62.83 to 144.54
|
101.51 F Ab Unit/mL
Interval 75.45 to 136.58
|
67.93 F Ab Unit/mL
Interval 30.62 to 150.71
|
92.34 F Ab Unit/mL
Interval 76.64 to 111.25
|
70.18 F Ab Unit/mL
Interval 55.27 to 89.11
|
82.13 F Ab Unit/mL
Interval 64.16 to 105.14
|
|
Geometric Mean Concentrations of Serum Antibodies Against RSV by Anti F Immunoglobulin G (IgG) Assay
Day 29
|
1328.36 F Ab Unit/mL
Interval 958.76 to 1840.45
|
1433.98 F Ab Unit/mL
Interval 1053.24 to 1952.34
|
1047.68 F Ab Unit/mL
Interval 810.79 to 1353.79
|
1003.07 F Ab Unit/mL
Interval 566.77 to 1775.23
|
92.94 F Ab Unit/mL
Interval 76.81 to 112.46
|
1066.90 F Ab Unit/mL
Interval 836.1 to 1361.42
|
1474.47 F Ab Unit/mL
Interval 1110.41 to 1957.9
|
|
Geometric Mean Concentrations of Serum Antibodies Against RSV by Anti F Immunoglobulin G (IgG) Assay
Day 61
|
1050.29 F Ab Unit/mL
Interval 774.32 to 1424.61
|
—
|
—
|
852.27 F Ab Unit/mL
Interval 491.53 to 1477.76
|
104.00 F Ab Unit/mL
Interval 80.54 to 134.3
|
850.91 F Ab Unit/mL
Interval 661.84 to 1093.99
|
1097.04 F Ab Unit/mL
Interval 816.4 to 1474.15
|
|
Geometric Mean Concentrations of Serum Antibodies Against RSV by Anti F Immunoglobulin G (IgG) Assay
Day 91
|
817.05 F Ab Unit/mL
Interval 603.67 to 1105.86
|
—
|
—
|
662.15 F Ab Unit/mL
Interval 375.5 to 1167.62
|
95.29 F Ab Unit/mL
Interval 77.73 to 116.82
|
705.96 F Ab Unit/mL
Interval 547.07 to 910.99
|
845.04 F Ab Unit/mL
Interval 636.42 to 1122.04
|
|
Geometric Mean Concentrations of Serum Antibodies Against RSV by Anti F Immunoglobulin G (IgG) Assay
Day 181
|
501.47 F Ab Unit/mL
Interval 368.62 to 682.2
|
—
|
—
|
403.58 F Ab Unit/mL
Interval 226.56 to 718.92
|
91.54 F Ab Unit/mL
Interval 74.62 to 112.29
|
466.81 F Ab Unit/mL
Interval 363.97 to 598.71
|
531.43 F Ab Unit/mL
Interval 398.1 to 709.41
|
|
Geometric Mean Concentrations of Serum Antibodies Against RSV by Anti F Immunoglobulin G (IgG) Assay
Day 271
|
389.94 F Ab Unit/mL
Interval 286.92 to 529.96
|
—
|
—
|
341.99 F Ab Unit/mL
Interval 160.13 to 730.4
|
92.70 F Ab Unit/mL
Interval 75.46 to 113.88
|
356.11 F Ab Unit/mL
Interval 276.99 to 457.84
|
423.30 F Ab Unit/mL
Interval 316.79 to 565.61
|
|
Geometric Mean Concentrations of Serum Antibodies Against RSV by Anti F Immunoglobulin G (IgG) Assay
Day 361
|
343.64 F Ab Unit/mL
Interval 255.99 to 461.32
|
—
|
—
|
284.56 F Ab Unit/mL
Interval 140.69 to 575.55
|
94.10 F Ab Unit/mL
Interval 74.03 to 119.61
|
305.10 F Ab Unit/mL
Interval 235.9 to 394.6
|
354.13 F Ab Unit/mL
Interval 268.29 to 467.43
|
SECONDARY outcome
Timeframe: Day 29, 61, 91, 181, 271, and 361Population: Immunogenicity Population. Here, 'n' is number of participants analyzed for this outcome measure at given time points.
The Anti F IgG antibodies were derived from the RSV-specific 4-plex MSD assay developed on the Meso Scale discovery platform. Humoral immunogenicity samples were used to assess anti-F IgG antibodies measured using a 4-plex Meso Scale Discovery (MSD) platform assay. Results through Day 361 are presented.
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=38 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
GMFRs of Serum Antibodies Against RSV by Anti F IgG Assay
Day 29
|
13.33 Fold rise
Interval 9.39 to 18.93
|
15.15 Fold rise
Interval 10.18 to 22.55
|
10.32 Fold rise
Interval 7.87 to 13.54
|
14.77 Fold rise
Interval 7.63 to 28.59
|
0.99 Fold rise
Interval 0.96 to 1.02
|
15.20 Fold rise
Interval 11.29 to 20.47
|
17.95 Fold rise
Interval 14.06 to 22.91
|
|
GMFRs of Serum Antibodies Against RSV by Anti F IgG Assay
Day 61
|
10.54 Fold rise
Interval 7.73 to 14.37
|
—
|
—
|
12.55 Fold rise
Interval 6.55 to 24.04
|
1.09 Fold rise
Interval 0.91 to 1.32
|
12.13 Fold rise
Interval 9.2 to 15.98
|
13.35 Fold rise
Interval 10.51 to 16.96
|
|
GMFRs of Serum Antibodies Against RSV by Anti F IgG Assay
Day 91
|
8.20 Fold rise
Interval 6.09 to 11.05
|
—
|
—
|
9.75 Fold rise
Interval 5.37 to 17.7
|
1.00 Fold rise
Interval 0.95 to 1.05
|
10.06 Fold rise
Interval 7.74 to 13.07
|
10.28 Fold rise
Interval 8.18 to 12.94
|
|
GMFRs of Serum Antibodies Against RSV by Anti F IgG Assay
Day 181
|
5.03 Fold rise
Interval 3.89 to 6.5
|
—
|
—
|
5.94 Fold rise
Interval 3.58 to 9.85
|
0.97 Fold rise
Interval 0.92 to 1.02
|
6.65 Fold rise
Interval 5.23 to 8.47
|
6.23 Fold rise
Interval 5.01 to 7.74
|
|
GMFRs of Serum Antibodies Against RSV by Anti F IgG Assay
Day 271
|
3.91 Fold rise
Interval 3.05 to 5.02
|
—
|
—
|
4.92 Fold rise
Interval 3.11 to 7.77
|
0.96 Fold rise
Interval 0.91 to 1.01
|
5.14 Fold rise
Interval 4.09 to 6.44
|
4.75 Fold rise
Interval 3.76 to 5.99
|
|
GMFRs of Serum Antibodies Against RSV by Anti F IgG Assay
Day 361
|
3.45 Fold rise
Interval 2.74 to 4.33
|
—
|
—
|
4.22 Fold rise
Interval 2.61 to 6.8
|
0.96 Fold rise
Interval 0.91 to 1.02
|
4.47 Fold rise
Interval 3.55 to 5.65
|
4.07 Fold rise
Interval 3.29 to 5.03
|
SECONDARY outcome
Timeframe: Day 29Population: Immunogenicity population.
Seroresponse defined as a greater than or equal to (\>=) 3-fold rise from baseline. Humoral immunity against RSV was assessed by an Anti-F IgG assay derived from the RSV-specific 4-plex MSD assay.
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=38 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Post-dose Seroresponse to RSV by Anti-F IgG Assay
|
94.9 Percentage of Participants
Interval 82.68 to 99.37
|
89.5 Percentage of Participants
Interval 75.2 to 97.06
|
90.0 Percentage of Participants
Interval 76.34 to 97.21
|
85.0 Percentage of Participants
Interval 62.11 to 96.79
|
0 Percentage of Participants
Interval 0.0 to 8.22
|
97.5 Percentage of Participants
Interval 86.84 to 99.94
|
97.3 Percentage of Participants
Interval 85.84 to 99.93
|
SECONDARY outcome
Timeframe: Day 29Population: Immunogenicity Population.
The ratio of post-dose HAI antibody GMTs and GMFRs in the IIV group and the MEDI7510 plus IIV group was provided by strain and by cohort for Cohorts 2 and 3 to check the effect of MEDI7510 on IIV when administered together. Humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed on Day 29 by each strain (H1N1, H3N2, B/Yamagata).
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=38 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=37 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Ratios of GMTs and GMFRs of Hemagglutination Inhibition (HAI) Antibodies
GMT: H1N1
|
NA Ratio
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
|
1.19 Ratio
Interval 0.71 to 1.99
|
NA Ratio
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
|
1.01 Ratio
Interval 0.63 to 1.61
|
—
|
—
|
—
|
|
Ratios of GMTs and GMFRs of Hemagglutination Inhibition (HAI) Antibodies
GMT: H3N2
|
NA Ratio
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
|
1.53 Ratio
Interval 1.03 to 2.28
|
NA Ratio
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
|
0.78 Ratio
Interval 0.53 to 1.15
|
—
|
—
|
—
|
|
Ratios of GMTs and GMFRs of Hemagglutination Inhibition (HAI) Antibodies
GMT: B/Yamagata
|
NA Ratio
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
|
1.38 Ratio
Interval 0.81 to 2.36
|
NA Ratio
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
|
1.49 Ratio
Interval 0.91 to 2.46
|
—
|
—
|
—
|
|
Ratios of GMTs and GMFRs of Hemagglutination Inhibition (HAI) Antibodies
GMFR: H1N1
|
NA Ratio
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
|
1.13 Ratio
Interval 0.68 to 1.87
|
NA Ratio
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
|
0.97 Ratio
Interval 0.54 to 1.75
|
—
|
—
|
—
|
|
Ratios of GMTs and GMFRs of Hemagglutination Inhibition (HAI) Antibodies
GMFR: H3N2
|
NA Ratio
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
|
1.53 Ratio
Interval 0.86 to 2.72
|
NA Ratio
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
|
1.28 Ratio
Interval 0.69 to 2.38
|
—
|
—
|
—
|
|
Ratios of GMTs and GMFRs of Hemagglutination Inhibition (HAI) Antibodies
GMFR: B/Yamagata
|
NA Ratio
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
|
1.09 Ratio
Interval 0.76 to 1.55
|
NA Ratio
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
|
1.00 Ratio
Interval 0.71 to 1.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 8Population: Immunogenicity Population. Here, 'n' is number of participants analyzed for this outcome measure at given time points.
The Geometric Mean Counts assessed by the ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples.
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=38 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=37 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=34 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=39 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=38 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Counts of Cellular Immune Response Against RSV by Respiratory Syncytial Virus Fusion Protein (RSV F) Interferon Gamma (IFNγ) Enzyme-linked Immunosorbent Spot (ELISPOT) Assay
Baseline (Day 1)
|
66.06 Spot forming counts per 10^6 PBMCs
Interval 53.4 to 81.72
|
47.21 Spot forming counts per 10^6 PBMCs
Interval 39.96 to 55.77
|
50.89 Spot forming counts per 10^6 PBMCs
Interval 42.19 to 61.38
|
42.24 Spot forming counts per 10^6 PBMCs
Interval 33.84 to 52.73
|
58.53 Spot forming counts per 10^6 PBMCs
Interval 47.1 to 72.74
|
45.71 Spot forming counts per 10^6 PBMCs
Interval 38.9 to 53.71
|
62.63 Spot forming counts per 10^6 PBMCs
Interval 49.89 to 78.61
|
|
Geometric Mean Counts of Cellular Immune Response Against RSV by Respiratory Syncytial Virus Fusion Protein (RSV F) Interferon Gamma (IFNγ) Enzyme-linked Immunosorbent Spot (ELISPOT) Assay
Day 8
|
436.72 Spot forming counts per 10^6 PBMCs
Interval 333.87 to 571.25
|
341.02 Spot forming counts per 10^6 PBMCs
Interval 222.54 to 522.58
|
430.33 Spot forming counts per 10^6 PBMCs
Interval 308.22 to 600.83
|
379.28 Spot forming counts per 10^6 PBMCs
Interval 225.9 to 636.8
|
54.30 Spot forming counts per 10^6 PBMCs
Interval 43.86 to 67.24
|
376.43 Spot forming counts per 10^6 PBMCs
Interval 273.42 to 518.25
|
618.15 Spot forming counts per 10^6 PBMCs
Interval 463.46 to 824.48
|
SECONDARY outcome
Timeframe: Day 8Population: Immunogenicity Population.
The GMFRs assessed by the ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=34 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=26 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=30 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=19 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=32 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=35 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
GMFRs of Cellular Immune Response Against RSV by RSV F IFNγ ELISPOT Assay
|
6.45 Fold rise
Interval 4.88 to 8.52
|
6.77 Fold rise
Interval 4.13 to 11.09
|
8.67 Fold rise
Interval 6.38 to 11.78
|
8.87 Fold rise
Interval 4.99 to 15.77
|
0.89 Fold rise
Interval 0.76 to 1.04
|
8.23 Fold rise
Interval 5.92 to 11.46
|
10.48 Fold rise
Interval 7.82 to 14.03
|
SECONDARY outcome
Timeframe: Day 8Population: Immunogenicity Population.
Seroresponse defined as a greater than or equal to (\>=) 3-fold rise from baseline. The Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples.
Outcome measures
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=34 Participants
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=26 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=30 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=19 Participants
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=32 Participants
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
n=35 Participants
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Post-dose Cell-mediated Immune Response to RSV F by RSV F Peptide Pool IFNγ ELISPOT
|
76.5 Percentage of Participants
Interval 58.83 to 89.25
|
80.8 Percentage of Participants
Interval 60.65 to 93.45
|
90.0 Percentage of Participants
Interval 73.47 to 97.89
|
78.9 Percentage of Participants
Interval 54.43 to 93.95
|
0.00 Percentage of Participants
Interval 0.0 to 10.89
|
82.5 Percentage of Participants
Interval 67.22 to 92.66
|
97.1 Percentage of Participants
Interval 85.08 to 99.93
|
Adverse Events
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Inactivated Influenza Vaccine (IIV)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 participants at risk
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 participants at risk
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 participants at risk
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 participants at risk
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 participants at risk
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3
n=39 participants at risk
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 participants at risk
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
Other adverse events
| Measure |
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
n=39 participants at risk
Participants received single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
|
Inactivated Influenza Vaccine (IIV)
n=44 participants at risk
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
n=39 participants at risk
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
n=40 participants at risk
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
n=40 participants at risk
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3
n=39 participants at risk
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
|
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
n=20 participants at risk
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
5.0%
1/20 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Eye disorders
Blepharospasm
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
5.0%
1/20 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
General disorders
Axillary pain
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
General disorders
Fatigue
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
5.0%
1/20 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
General disorders
Injection site reaction
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
General disorders
Pyrexia
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Infections and infestations
Cellulitis
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Infections and infestations
Laryngitis
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Infections and infestations
Rhinitis
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
6.8%
3/44 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
5.0%
1/20 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
5.0%
2/40 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
5.0%
1/20 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
5.0%
1/20 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Injury, poisoning and procedural complications
Wound haematoma
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
5.0%
1/20 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Nervous system disorders
Headache
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.6%
1/39 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
5.0%
2/40 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
5.0%
1/20 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/44 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
5.0%
1/20 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
|
Vascular disorders
Hypertension
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
2.3%
1/44 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/40 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/39 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
0.00%
0/20 • AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
|
Additional Information
Judith Falloon, MD, FACP, FIDSA, Senior Director, Clinical Development
MedImmune LLC
Phone: +1-301-398-4010
Email: [email protected]
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