Trial Outcomes & Findings for A Study to Evaluate the Efficacy of MEDI7510 in Older Adults (NCT NCT02508194)
NCT ID: NCT02508194
Last Updated: 2017-12-26
Results Overview
ARA-RI was defined as an event in which a participant met specified clinical criteria and the event was laboratory-confirmed to be RSV-related. The specified clinical criteria included a minimum of 1 symptom from any 2 of the 3 symptom columns: one symptom from upper respiratory symptom column and one symptom from lower respiratory symptom column; one symptom from upper respiratory symptom column and one symptom from systemic symptom column; or one symptom from lower respiratory column and one from systemic symptom column and laboratory confirmation of RSV on at least 1 sample obtained between Day 1 to Day 8 of illness. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.
TERMINATED
PHASE2
1900 participants
Day 14 after dosing through end of surveillance period (approximately 7 months)
2017-12-26
Participant Flow
A total of 1900 participants were randomized and participated in the study at 60 sites in 7 countries.
A total of 2,044 participants were screened, of which 144 participants were screen failures and 1900 participants were randomized in the study.
Participant milestones
| Measure |
Placebo + Inactivated Influenza Vaccine (IIV)
Participants received a single intramuscular (IM) injection of placebo (matched with MEDI7510) in one arm and single IM injection of (IIV) in the contralateral arm.
|
MEDI7510 + IIV
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Overall Study
STARTED
|
949
|
951
|
|
Overall Study
COMPLETED
|
897
|
907
|
|
Overall Study
NOT COMPLETED
|
52
|
44
|
Reasons for withdrawal
| Measure |
Placebo + Inactivated Influenza Vaccine (IIV)
Participants received a single intramuscular (IM) injection of placebo (matched with MEDI7510) in one arm and single IM injection of (IIV) in the contralateral arm.
|
MEDI7510 + IIV
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Overall Study
Death
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
25
|
18
|
|
Overall Study
Withdrawal by Subject
|
20
|
18
|
|
Overall Study
Error in Randomization
|
1
|
3
|
|
Overall Study
Principal Investigator Decision
|
1
|
2
|
Baseline Characteristics
A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
Baseline characteristics by cohort
| Measure |
Placebo + IIV
n=949 Participants
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510 + IIV
n=951 Participants
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
Total
n=1900 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 Years
STANDARD_DEVIATION 6.2 • n=93 Participants
|
68.1 Years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
68.1 Years
STANDARD_DEVIATION 6.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
587 Participants
n=93 Participants
|
530 Participants
n=4 Participants
|
1117 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
362 Participants
n=93 Participants
|
421 Participants
n=4 Participants
|
783 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 14 after dosing through end of surveillance period (approximately 7 months)Population: Per-protocol population: All participants in the as-treated population (ATP) who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period. Participants who met the primary endpoint criteria and were not followed until the end of the RSV surveillance period were also included in the per-protocol population.
ARA-RI was defined as an event in which a participant met specified clinical criteria and the event was laboratory-confirmed to be RSV-related. The specified clinical criteria included a minimum of 1 symptom from any 2 of the 3 symptom columns: one symptom from upper respiratory symptom column and one symptom from lower respiratory symptom column; one symptom from upper respiratory symptom column and one symptom from systemic symptom column; or one symptom from lower respiratory column and one from systemic symptom column and laboratory confirmation of RSV on at least 1 sample obtained between Day 1 to Day 8 of illness. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.
Outcome measures
| Measure |
Placebo + IIV
n=935 Participants
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510 + IIV
n=931 Participants
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1
|
1.6 Percentage of Participants
|
1.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 14 after dosing through end of surveillance period (approximately 7 months)Population: Per-protocol population: All participants in the ATP who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period. Participants who met the primary endpoint criteria and were not followed until the end of the RSV surveillance period were also included in the per-protocol population.
Detection of RSV was done by PCR method by using any respiratory sample. The incidence of RSV PCR-positive respiratory illness during the RSV surveillance period was evaluated. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.
Outcome measures
| Measure |
Placebo + IIV
n=935 Participants
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510 + IIV
n=931 Participants
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1
|
1.6 Percentage of Participants
|
1.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 29, and End of Season 1 (approximately 1 year)Population: Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510.
Anti-F IgG antibodies concentration were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 \[mean (log2 xi)\], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year.
Outcome measures
| Measure |
Placebo + IIV
n=947 Participants
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510 + IIV
n=946 Participants
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 1
|
83.39 Fragment antigen-binding (F AB) unit/mL
Interval 78.91 to 88.12
|
77.96 Fragment antigen-binding (F AB) unit/mL
Interval 73.66 to 82.5
|
|
Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 29
|
80.05 Fragment antigen-binding (F AB) unit/mL
Interval 75.68 to 84.68
|
999.03 Fragment antigen-binding (F AB) unit/mL
Interval 944.4 to 1056.81
|
|
Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
End of Season 1
|
79.95 Fragment antigen-binding (F AB) unit/mL
Interval 75.27 to 84.93
|
370.88 Fragment antigen-binding (F AB) unit/mL
Interval 350.9 to 391.99
|
SECONDARY outcome
Timeframe: Day 29 and End of Season 1 (approximately 1 year)Population: Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510.
Anti-F IgG antibodies concentration was determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 \[mean (log2 yi)\], where "yi" is the post dose antibody concentration or T-cell count fold change from baseline for each participant. The Season 1 was approximately 1 year.
Outcome measures
| Measure |
Placebo + IIV
n=947 Participants
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510 + IIV
n=946 Participants
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay
Day 29
|
0.96 Fold Change
Interval 0.94 to 0.98
|
12.78 Fold Change
Interval 11.96 to 13.65
|
|
Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay
End of Season 1
|
0.94 Fold Change
Interval 0.91 to 0.96
|
4.60 Fold Change
Interval 4.34 to 4.88
|
SECONDARY outcome
Timeframe: Day 29 and End of Season 1 (approximately 1 year)Population: Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510.
Anti-F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. Seroresponse was defined as a greater than or equal to (\>=) 3-fold rise of serum antibodies against RSV from baseline. The Season 1 was approximately 1 year.
Outcome measures
| Measure |
Placebo + IIV
n=947 Participants
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510 + IIV
n=946 Participants
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay
Day 29
|
0.8 Percentage of Participants
Interval 0.3 to 1.5
|
92.9 Percentage of Participants
Interval 91.0 to 94.4
|
|
Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay
End of Season 1
|
1.6 Percentage of Participants
Interval 0.9 to 2.7
|
65.8 Percentage of Participants
Interval 62.5 to 69.0
|
SECONDARY outcome
Timeframe: Day 1 (post-dose) and Day 29 of Season 1Population: Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine.
GMT was calculated as: anti-log2 \[mean (log2 xi)\], where "xi" is an antibodies concentration of participants. GMTs of strain-Specific HAI antibodies (H1N1, H3N2, B Brisbane, and B Phuket) were reported. The Season 1 was approximately 1 year.
Outcome measures
| Measure |
Placebo + IIV
n=464 Participants
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510 + IIV
n=451 Participants
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
H1N1, Day 1
|
54.26 Titer
Interval 48.61 to 60.565
|
55.77 Titer
Interval 50.066 to 62.115
|
|
Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
H1N1, Day 29
|
161.26 Titer
Interval 146.241 to 177.823
|
155.14 Titer
Interval 141.356 to 170.264
|
|
Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
B PHUKET, Day 29
|
30.00 Titer
Interval 27.088 to 33.219
|
28.29 Titer
Interval 25.526 to 31.348
|
|
Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
H3N2, Day 1
|
34.81 Titer
Interval 31.224 to 38.804
|
35.99 Titer
Interval 32.271 to 40.136
|
|
Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
H3N2, Day 29
|
291.73 Titer
Interval 260.581 to 326.604
|
269.58 Titer
Interval 241.784 to 300.569
|
|
Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
B BRISBANE, Day 1
|
12.89 Titer
Interval 11.851 to 14.025
|
13.46 Titer
Interval 12.357 to 14.672
|
|
Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
B BRISBANE, Day 29
|
32.49 Titer
Interval 29.314 to 36.007
|
30.15 Titer
Interval 27.334 to 33.257
|
|
Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
B PHUKET, Day 1
|
11.42 Titer
Interval 10.514 to 12.402
|
11.81 Titer
Interval 10.857 to 12.841
|
SECONDARY outcome
Timeframe: Day 29 of Season 1Population: Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine.
Geometric mean fold change was calculated as: anti-log2 \[mean (log2 yi)\], where "yi" is the post dose antibody concentration or T-cell count fold change from baseline for each participant. Geometric mean fold change of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) were reported. The Season 1 was approximately 1 year.
Outcome measures
| Measure |
Placebo + IIV
n=464 Participants
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510 + IIV
n=451 Participants
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
H1N1
|
2.97 Fold Change
Interval 2.652 to 3.329
|
2.78 Fold Change
Interval 2.501 to 3.094
|
|
Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
H3N2
|
8.42 Fold Change
Interval 7.525 to 9.421
|
7.49 Fold Change
Interval 6.669 to 8.414
|
|
Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
B BRISBANE
|
2.53 Fold Change
Interval 2.301 to 2.771
|
2.24 Fold Change
Interval 2.068 to 2.425
|
|
Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
B PHUKET
|
2.63 Fold Change
Interval 2.419 to 2.85
|
2.40 Fold Change
Interval 2.217 to 2.589
|
SECONDARY outcome
Timeframe: Day 29 of Season 1Population: Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine.
Seroresponse was defined as a \>= 4-fold rise of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) from baseline. The Season 1 was approximately 1 year.
Outcome measures
| Measure |
Placebo + IIV
n=464 Participants
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510 + IIV
n=451 Participants
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody
B BRISBANE
|
31.7 Percentage of Participants
|
26.9 Percentage of Participants
|
|
Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody
H1N1
|
32.6 Percentage of Participants
|
32.4 Percentage of Participants
|
|
Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody
H3N2
|
76.5 Percentage of Participants
|
74.2 Percentage of Participants
|
|
Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody
B PHUKET
|
33.0 Percentage of Participants
|
30.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 29 and End of Season 1 (approximately 1 year)Population: Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.
Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMT was to be calculated as: anti-log2 \[mean (log2 xi)\], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29 and End of Season 1 (approximately 1 year)Population: Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.
Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 \[mean (log2 yi)\], where "yi" is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29 and End of Season 1 (approximately 1 year)Population: Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.
Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a \>= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29 and End of Season 1 (approximately 1 year)Population: Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.
Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMC was to be calculated as: anti-log2 \[mean (log2 xi)\], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29 and End of Season 1 (approximately 1 year)Population: Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.
Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 \[mean (log2 yi)\], where "yi" is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29 and End of Season 1 (approximately 1 year)Population: Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.
Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a \>= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (post-dose) through Day 7Population: ATP: Participants who received any dose of investigational product (IP). Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.
Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever \>= 100.4 degrees Fahrenheit by any route from Day 1 to Day 7.
Outcome measures
| Measure |
Placebo + IIV
n=948 Participants
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510 + IIV
n=946 Participants
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Number of Participants With Any Solicited Symptoms
|
558 Participants
|
606 Participants
|
SECONDARY outcome
Timeframe: Day 1 (post-dose) through Day 29Population: ATP: Participants who received any dose of IP. Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 29 that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Placebo + IIV
n=948 Participants
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510 + IIV
n=946 Participants
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
|
141 Participants
|
146 Participants
|
SECONDARY outcome
Timeframe: Day 1 (post-dose) through end of Season 1 (approximately 1 year)Population: ATP: Participants who received any dose of IP. Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.
An serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and approximately 1 year follow up that were absent before treatment or that worsened relative to pretreatment state. An adverse event of special interest was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. The Season 1 was approximately 1 year.
Outcome measures
| Measure |
Placebo + IIV
n=948 Participants
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510 + IIV
n=946 Participants
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)
TESAEs
|
3 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)
NOCDs
|
5 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)
TEAESIs
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo + IIV
MEDI7510+IIV
Serious adverse events
| Measure |
Placebo + IIV
n=948 participants at risk
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510+IIV
n=946 participants at risk
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Cardiac disorders
Angina unstable
|
0.21%
2/948 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.21%
2/946 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Cardiac disorders
Arrhythmia
|
0.21%
2/948 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.42%
4/946 • Number of events 5 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Cardiac disorders
Cardiac failure acute
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Cardiac disorders
Coronary artery disease
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.21%
2/946 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Cardiac disorders
Myocardial infarction
|
0.63%
6/948 • Number of events 7 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Endocrine disorders
Goitre
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Eye disorders
Glaucoma
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.21%
2/946 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
General disorders
Death
|
0.21%
2/948 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
General disorders
Non-cardiac chest pain
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Abscess limb
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Bronchitis
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Cellulitis
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Device related infection
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Diverticulitis
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Epididymitis
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Infected lymphocele
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Localised infection
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Osteomyelitis
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Pneumonia
|
0.32%
3/948 • Number of events 3 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Pneumonia influenzal
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Sepsis
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Septic shock
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Tracheobronchitis
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Urinary tract infection
|
0.21%
2/948 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Wound infection
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Injury, poisoning and procedural complications
Overdose
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.21%
2/946 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.53%
5/948 • Number of events 5 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.21%
2/946 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.32%
3/948 • Number of events 3 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal neoplasm
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.21%
2/946 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage i
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.32%
3/948 • Number of events 3 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Nervous system disorders
Syncope
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
3/948 • Number of events 3 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Product Issues
Device dislocation
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Product Issues
Device failure
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.21%
2/946 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Renal and urinary disorders
Haematuria
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.11%
1/948 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.11%
1/948 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.21%
2/948 • Number of events 2 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Vascular disorders
Aortic occlusion
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Vascular disorders
Arteriosclerosis
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Vascular disorders
Hypertension
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/948 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.11%
1/946 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Vascular disorders
Peripheral artery occlusion
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Vascular disorders
Peripheral vascular disorder
|
0.11%
1/948 • Number of events 1 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
0.00%
0/946 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
Other adverse events
| Measure |
Placebo + IIV
n=948 participants at risk
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
|
MEDI7510+IIV
n=946 participants at risk
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
|
|---|---|---|
|
General disorders
Fatigue
|
1.2%
11/948 • Number of events 13 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
1.7%
16/946 • Number of events 19 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
General disorders
Injection site pain
|
1.9%
18/948 • Number of events 35 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
1.1%
10/946 • Number of events 28 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
10/948 • Number of events 10 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
1.7%
16/946 • Number of events 16 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.1%
10/948 • Number of events 10 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
1.4%
13/946 • Number of events 13 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
|
Nervous system disorders
Headache
|
1.4%
13/948 • Number of events 15 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
1.1%
10/946 • Number of events 11 • Day 1 (post-dose) through end of Season 1 (approximately 1 year)
|
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 on-going 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