Trial Outcomes & Findings for Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV) (NCT NCT01475305)
NCT ID: NCT01475305
Last Updated: 2017-07-21
Results Overview
RSV infection is defined as positive plaque assay culture sample for greater than or equal to (\>=) 1 day through 12 days post-RSV challenge. A sample was determined positive if log10 plaque-forming units per milliliter \[pfu/mL\] greater than or equal lower limit of quantitation (LLOQ; 1.69 log10 pfu/mL) and 2 of the 3 replicates must have greater than (\>) 0 pfu/mL.
TERMINATED
PHASE1
7 participants
From Day 4 to Day 15
2017-07-21
Participant Flow
A total of 90 participants were screened, out of these, 7 participants were randomized and completed the study.
Participant milestones
| Measure |
Placebo
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
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|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
End of Quarantine, Day 15
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=3 Participants
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
Total
n=7 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
24.5 Years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
28.0 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
26.0 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 4 to Day 15Population: Population for RSV Incidence included all participants who received both the investigational product and RSV challenge.
RSV infection is defined as positive plaque assay culture sample for greater than or equal to (\>=) 1 day through 12 days post-RSV challenge. A sample was determined positive if log10 plaque-forming units per milliliter \[pfu/mL\] greater than or equal lower limit of quantitation (LLOQ; 1.69 log10 pfu/mL) and 2 of the 3 replicates must have greater than (\>) 0 pfu/mL.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=3 Participants
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
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Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture
|
66.7 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 4 to Day 15Population: Population for RSV Incidence included all participants who received both the investigational product and RSV challenge.
RSV infection defined as positive quantitative real-time RT-PCR (RSV-A only) sample for \>= 2 consecutive days through 12 days post-RSV challenge. A sample was determined positive if log10 copies/ml \>= limit of quantitation (LLOQ; 2.80 log10 copies/mL). RSV infection defined as positive DFA sample for \>= 2 consecutive days through 12 days post-RSV challenge. RSV infection by any method included positive plaque assay culture sample for \>=1 day through 12 days post-RSV challenge, or positive quantitative real-time RT-PCR (RSV-A only) sample for \>= 2 consecutive days through 12 days post-RSV challenge, or positive DFA sample for \>=2 consecutive days through 12 days post-RSV challenge.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=3 Participants
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
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Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method
RSV infection by quantitative real-time RT-PCR
|
66.7 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method
RSV infection by DFA
|
66.7 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method
RSV infection by Any Method
|
66.7 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 5 through Day 31Population: Population for RSV Plaque Assay Culture Virology included all participants who received both investigational product and RSV challenge and were positive for RSV by plaque assay culture (defined as positive sample for \>=1 day through 12 days post-RSV challenge).
RSV infection by plaque assay culture defined as positive sample for \>= 1 day through 12 days post-RSV challenge.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
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Mean Viral Load AUC0-t by Plaque Assay Culture
|
42.165 log10 pfu*day/mL
Standard Deviation 3.305
|
—
|
SECONDARY outcome
Timeframe: From Day 5 through Day 31Population: Population for RSV Quantitative Real-Time RT-PCR Virology included all participants who received both the investigational product and RSV challenge and were positive for RSV-A by quantitative real-time RT-PCR (defined as positive samples for \>= 2 consecutive days through 12 days post-RSV challenge).
RSV infection by plaque assay culture defined as positive sample for \>= 2 consecutive days through 12 days post-RSV challenge.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=2 Participants
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Mean Viral Load AUC0-t by Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
|
100.04 log10 copies*day/mL
Standard Deviation 7.000
|
65.708 log10 copies*day/mL
Standard Deviation 1.488
|
SECONDARY outcome
Timeframe: From Day 5 through Day 31Population: Population for RSV Plaque Assay Culture Virology included all participants who received both investigational product and RSV challenge and were positive for RSV by plaque assay culture (defined as positive sample for \>= 1 day through 12 days post-RSV challenge).
RSV infection by plaque assay culture defined as positive sample for \>= 1 day through 12 days post-RSV challenge. log10 pfu/mL = log10 plaque-forming unit per milliliter.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Mean Nasal RSV Peak as Measured by Plaque Assay Culture
|
4.150 log10 pfu/mL
Standard Deviation 0.521
|
—
|
SECONDARY outcome
Timeframe: From Day 5 through Day 31Population: Population for RSV Quantitative Real-Time RT-PCR Virology included all participants who received both the investigational product and RSV challenge and were positive for RSV-A by quantitative real-time RT-PCR (defined as positive samples for \>= 2 consecutive days through 12 days post-RSV challenge).
RSV infection by plaque assay culture defined as positive sample for \>= 2 consecutive days through 12 days post-RSV challenge.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=2 Participants
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Mean Nasal RSV Peak as Measured by Quantitative Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
|
7.700 log10 copies/mL
Standard Deviation 0.453
|
4.260 log10 copies/mL
Standard Deviation 0.863
|
SECONDARY outcome
Timeframe: From Day 5 through Day 31Population: Population for RSV Incidence by any Viral Assay included all participants who received both the investigational product and RSV challenge and were positive for RSV by plaque assay culture, quantitative real-time RT-PCR, or DFA.
Duration of viral shedding defined as the number of days from the first sample positive by any assay (that is, plaque assay culture, quantitative real-time (RT-PCR), or direct fluorescent Antibody (DFA) to the last sample positive by any assay.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=2 Participants
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
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|---|---|---|
|
Duration of Respiratory Syncytial Virus (RSV) Viral Shedding
|
10.0 days
Full Range 0.0 • Interval 10.0 to 10.0
|
6.5 days
Full Range 4.5 • Interval 2.0 to 11.0
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK. Here n = participants evaluable for specified categories, for each arm, respectively.
MEDI-557 serum concentrations were summarized by each sampling point \[LLOQ for MEDI-557 concentration assay was 1.56 microgram per millilitre (μg/mL) for serum\].
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 1 (pre-dose) (n=3)
|
0.000 microgram per milliliter (ug/mL)
Standard Deviation 0.000
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
1 hr Post-dose (n=3)
|
498.730 microgram per milliliter (ug/mL)
Standard Deviation 6.615
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
4 hr Post-dose (n=3)
|
462.937 microgram per milliliter (ug/mL)
Standard Deviation 40.212
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
8 hr Post-dose (n=3)
|
458.413 microgram per milliliter (ug/mL)
Standard Deviation 40.613
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 2 (n=3)
|
407.627 microgram per milliliter (ug/mL)
Standard Deviation 13.420
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 3 (n=3)
|
343.283 microgram per milliliter (ug/mL)
Standard Deviation 48.078
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 5 (n=3)
|
298.020 microgram per milliliter (ug/mL)
Standard Deviation 48.966
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 7 (n=3)
|
287.917 microgram per milliliter (ug/mL)
Standard Deviation 39.276
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 9 (n=3)
|
293.897 microgram per milliliter (ug/mL)
Standard Deviation 33.128
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 11(n=3)
|
265.107 microgram per milliliter (ug/mL)
Standard Deviation 24.076
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 15 (n=3)
|
252.327 microgram per milliliter (ug/mL)
Standard Deviation 16.091
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 31 (n=3)
|
252.177 microgram per milliliter (ug/mL)
Standard Deviation 23.225
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 61 (n=2)
|
180.505 microgram per milliliter (ug/mL)
Standard Deviation 6.442
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 91 (n=3)
|
131.053 microgram per milliliter (ug/mL)
Standard Deviation 4.571
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 120 (n=3)
|
106.040 microgram per milliliter (ug/mL)
Standard Deviation 10.023
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 150 (n=3)
|
75.583 microgram per milliliter (ug/mL)
Standard Deviation 11.258
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 180 (n=3)
|
65.443 microgram per milliliter (ug/mL)
Standard Deviation 5.897
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 240 (n=2)
|
43.875 microgram per milliliter (ug/mL)
Standard Deviation 6.428
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 300 (n=3)
|
31.353 microgram per milliliter (ug/mL)
Standard Deviation 5.731
|
—
|
|
Mean Serum MEDI-557 Concentration Through Day 360
Day 360 (n=3)
|
20.343 microgram per milliliter (ug/mL)
Standard Deviation 4.138
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
The Cmax is the maximum observed serum concentration of MEDI-557.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of MEDI-557
|
504.0433 microgram per milliliter (mcg/ml)
Standard Deviation 6.6189
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Time to Reach Maximum Serum Concentration (Tmax) of MEDI-557
|
0.162 Day
Standard Deviation 0.068
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Serum Half Life (t1/2) of MEDI-557
|
94.0029426 Day
Standard Deviation 93.8412056
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
The AUC(0-t) is the area under the serum concentration-time curve from time zero to any time 't'.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557
|
34484.8642 day*microgram per milliliter (d*mcg/ml)
Standard Deviation 1114.4471
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of MEDI-557
|
37266.5740 d*mcg/ml
Standard Deviation 1764.7070
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC\[0-infinity\])\*(AUMC\[0-infinity\])/AUC\[0-infinity\]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the serum concentration-time curve from time zero to infinite time.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Volume of Distribution at Steady-State (Vss) of MEDI-557
|
6644.3433 milliliter (ml)
Standard Deviation 606.4269
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the serum Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC\[0-infinity\]).
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Mean Clearance of MEDI-557
|
50.3831 milliliter per day (ml/d)
Standard Deviation 4.6158
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
MEDI-557 nasal wash concentrations were summarized by each sampling point \[LLOQ for MEDI-557 concentration assay was 20.00 nanogram per millilitre (ng/mL) for nasal wash\].
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 1 (pre-dose)
|
0.000 nanogram per milliliter (ng/mL)
Standard Deviation 0.000
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 2
|
166.613 nanogram per milliliter (ng/mL)
Standard Deviation 8.257
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 5
|
192.827 nanogram per milliliter (ng/mL)
Standard Deviation 160.257
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 6
|
189.767 nanogram per milliliter (ng/mL)
Standard Deviation 87.745
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 7
|
227.980 nanogram per milliliter (ng/mL)
Standard Deviation 189.806
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 8
|
308.153 nanogram per milliliter (ng/mL)
Standard Deviation 173.823
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 9
|
201.647 nanogram per milliliter (ng/mL)
Standard Deviation 105.288
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 10
|
132.407 nanogram per milliliter (ng/mL)
Standard Deviation 134.702
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 11
|
220.953 nanogram per milliliter (ng/mL)
Standard Deviation 58.505
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 12
|
262.800 nanogram per milliliter (ng/mL)
Standard Deviation 310.692
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 13
|
89.867 nanogram per milliliter (ng/mL)
Standard Deviation 72.249
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 14
|
184.747 nanogram per milliliter (ng/mL)
Standard Deviation 260.718
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 15
|
243.567 nanogram per milliliter (ng/mL)
Standard Deviation 251.884
|
—
|
|
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
Day 31
|
62.707 nanogram per milliliter (ng/mL)
Standard Deviation 62.348
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
The Cmax is the maximum observed nasal wash concentration of MEDI-557.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Maximum Nasal Wash Concentration (Cmax) of MEDI-557
|
377.9800 nanogram per milliliter (ng/ml)
Standard Deviation 212.2542
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Time to Reach Maximum Nasal Wash Concentration (Tmax) of MEDI-557
|
9.051 Day
Standard Deviation 2.113
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
The AUC(0-t) is the area under the nasal wash concentration-time curve from time zero to any time 't'.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Area Under the Nasal Wash Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557
|
4541.3636 day*nanogram per milliliter (d*ng/ml)
Standard Deviation 3905.7874
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose); Day 31, 91, 150, 180, 240, 300 and 360 post-dosePopulation: Population for ADA included all participants who received any amount of investigational product and had \>= 1 post-baseline measurement for ADA. Here, "n" is number of participants analysed at specific time point.
Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. Antidrug antibodies to MEDI-557 were defined as a detectable antibody titer with a dilution value of 1:30 or greater.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=3 Participants
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Percentage of Participants With Positive Anti-MEDI-557 Antibodies
Day 1 (pre-dose) (n=4,3)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Positive Anti-MEDI-557 Antibodies
Day 31 (n=4,3)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Positive Anti-MEDI-557 Antibodies
Day 91 (n=4,3)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Positive Anti-MEDI-557 Antibodies
Day 150 (n=3,3)
|
0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Positive Anti-MEDI-557 Antibodies
Day 180 (n=4,3)
|
0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Positive Anti-MEDI-557 Antibodies
Day 240 (n=3,2)
|
0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Positive Anti-MEDI-557 Antibodies
Day 300 (n=4,3)
|
0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Positive Anti-MEDI-557 Antibodies
Day 360 (n=4,3)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 (immediately following administration of study drug) to Day 360Population: Safety Population included all participants who received any amount of investigational product.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and Day 360 that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=3 Participants
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: From Day 1 through Day 31Population: Safety Population included all participants who received any amount of investigational product.
Vital signs included temperature, respiration rate, heart rate, blood pressure. Abnormal vital sign parameters included Cardiac Disorders (Bradycardia), Respiratory, Thoracic and Mediastinal Disorders (Tachypnoea, Hyperventilation, Hypopnoea). Participants with abnormalities in these vital Signs investigations recorded as AEs were reported.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=3 Participants
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Number of Participants With Vital Signs Abnormalities Reported as Adverse Events (AEs)
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: From Day 1 through Day 91Population: Safety Population included all participants who received any amount of investigational product.
Laboratory investigations included hematology, coagulation, serum chemistry and urinalysis parameters. Participants with abnormalities in these laboratory investigations recorded as AEs were reported.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=3 Participants
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs)
Hematology
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs)
Coagulation
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs)
Serum chemistry
|
0 participants
|
2 participants
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs)
Urinalysis
|
0 participants
|
2 participants
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs)
Cardiac enzymes
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 1, 2, 3 (Baseline), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 31Population: Safety Population included all participants who received any amount of investigational product.
Spirometry is a standardized assessment to evaluate lung function. Baseline values for spirometry is defined as the last measure prior to viral challenge. Spirometry assessments included percent predicted forced expiratory volume in 1 second (FEV1), FEV1/forced vital capacity (FVC), and forced expiratory flow (FEF) 25%-75% values.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=3 Participants
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Number of Participants With Clinically Meaningful Changes From Baseline in Spirometry Values
|
0 participants
|
0 participants
|
Adverse Events
Placebo
MEDI-557
Serious adverse events
| Measure |
Placebo
n=4 participants at risk
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=3 participants at risk
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
Other adverse events
| Measure |
Placebo
n=4 participants at risk
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
|
MEDI-557
n=3 participants at risk
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Cardiac disorders
Bradycardia
|
25.0%
1/4 • Number of events 2 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Gastrointestinal disorders
Gingival pain
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Gastrointestinal disorders
Lip dry
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Gastrointestinal disorders
Toothache
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Immune system disorders
Seasonal allergy
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Infections and infestations
Gastroenteritis
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Infections and infestations
Respiratory tract infection viral
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Injury, poisoning and procedural complications
Excoriation
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 2 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Nervous system disorders
Presyncope
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Nervous system disorders
Tension headache
|
50.0%
2/4 • Number of events 4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
66.7%
2/3 • Number of events 3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
0.00%
0/4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
75.0%
3/4 • Number of events 4 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
100.0%
3/3 • Number of events 6 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
33.3%
1/3 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
|
Vascular disorders
Phlebitis
|
25.0%
1/4 • Number of events 1 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
0.00%
0/3 • From Day -2 to Day 360
Safety population included all participants who received any amount of investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER