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A Study to Evaluate the Efficacy of MEDI7510 in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02508194
Recruitment Status : Terminated (Year 1 of study completed. No enrollment planned for Year 2 of study.)
First Posted : July 24, 2015
Results First Posted : December 20, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Respiratory Syncytial Virus
Interventions Biological: MEDI7510
Biological: IIV
Other: Placebo
Enrollment 1900
Recruitment Details A total of 1900 participants were randomized and participated in the study at 60 sites in 7 countries.
Pre-assignment Details A total of 2,044 participants were screened, of which 144 participants were screen failures and 1900 participants were randomized in the study.
Arm/Group Title Placebo + Inactivated Influenza Vaccine (IIV) MEDI7510 + IIV
Hide Arm/Group Description 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. Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Period Title: Overall Study
Started 949 951
Completed 897 907
Not Completed 52 44
Reason Not Completed
Death             5             3
Lost to Follow-up             25             18
Withdrawal by Subject             20             18
Error in Randomization             1             3
Principal Investigator Decision             1             2
Arm/Group Title Placebo + IIV MEDI7510 + IIV Total
Hide Arm/Group Description Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm. Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm. Total of all reporting groups
Overall Number of Baseline Participants 949 951 1900
Hide Baseline Analysis Population Description
As-treated population (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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 949 participants 951 participants 1900 participants
68.1  (6.2) 68.1  (6.3) 68.1  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 949 participants 951 participants 1900 participants
Female
587
  61.9%
530
  55.7%
1117
  58.8%
Male
362
  38.1%
421
  44.3%
783
  41.2%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 14 after dosing through end of surveillance period (approximately 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 935 931
Measure Type: Number
Unit of Measure: Percentage of Participants
1.6 1.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + IIV, MEDI7510 + IIV
Comments 2 sided 90 percent (%) confidence interval (CI) was used to compare vaccine efficacy (VE). VE = ([1 - relative risk (RR)] *100%), where RR was the RR of ARA-RI in the MEDI7510 group compared with the placebo group. A lower bound of the 90% CI greater than (>) 0% would demonstrate the efficacy of MEDI7510.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value -7.1
Confidence Interval (2-Sided) 90%
-106.9 to 44.3
Estimation Comments The CI was estimated by an exact conditional method.
2.Secondary Outcome
Title Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1
Hide Description 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.
Time Frame Day 14 after dosing through end of surveillance period (approximately 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 935 931
Measure Type: Number
Unit of Measure: Percentage of Participants
1.6 1.7
3.Secondary Outcome
Title Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Hide Description 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.
Time Frame Day 1, Day 29, and End of Season 1 (approximately 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 947 946
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fragment antigen-binding (F AB) unit/mL
Day 1 Number Analyzed 944 participants 940 participants
83.39
(78.91 to 88.12)
77.96
(73.66 to 82.50)
Day 29 Number Analyzed 926 participants 924 participants
80.05
(75.68 to 84.68)
999.03
(944.40 to 1056.81)
End of Season 1 Number Analyzed 852 participants 857 participants
79.95
(75.27 to 84.93)
370.88
(350.90 to 391.99)
4.Secondary Outcome
Title Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay
Hide Description 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.
Time Frame Day 29 and End of Season 1 (approximately 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 947 946
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold Change
Day 29 Number Analyzed 926 participants 924 participants
0.96
(0.94 to 0.98)
12.78
(11.96 to 13.65)
End of Season 1 Number Analyzed 852 participants 857 participants
0.94
(0.91 to 0.96)
4.60
(4.34 to 4.88)
5.Secondary Outcome
Title Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay
Hide Description 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.
Time Frame Day 29 and End of Season 1 (approximately 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 947 946
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Day 29 Number Analyzed 926 participants 924 participants
0.8
(0.3 to 1.5)
92.9
(91 to 94.4)
End of Season 1 Number Analyzed 852 participants 857 participants
1.6
(0.9 to 2.7)
65.8
(62.5 to 69)
6.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
Hide Description 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.
Time Frame Day 1 (post-dose) and Day 29 of Season 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 464 451
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
H1N1, Day 1 Number Analyzed 462 participants 450 participants
54.26
(48.610 to 60.565)
55.77
(50.066 to 62.115)
H1N1, Day 29 Number Analyzed 460 participants 450 participants
161.26
(146.241 to 177.823)
155.14
(141.356 to 170.264)
H3N2, Day 1 Number Analyzed 462 participants 450 participants
34.81
(31.224 to 38.804)
35.99
(32.271 to 40.136)
H3N2, Day 29 Number Analyzed 460 participants 450 participants
291.73
(260.581 to 326.604)
269.58
(241.784 to 300.569)
B BRISBANE, Day 1 Number Analyzed 462 participants 450 participants
12.89
(11.851 to 14.025)
13.46
(12.357 to 14.672)
B BRISBANE, Day 29 Number Analyzed 460 participants 450 participants
32.49
(29.314 to 36.007)
30.15
(27.334 to 33.257)
B PHUKET, Day 1 Number Analyzed 462 participants 450 participants
11.42
(10.514 to 12.402)
11.81
(10.857 to 12.841)
B PHUKET, Day 29 Number Analyzed 460 participants 450 participants
30.00
(27.088 to 33.219)
28.29
(25.526 to 31.348)
7.Secondary Outcome
Title Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
Hide Description 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.
Time Frame Day 29 of Season 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 464 451
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold Change
H1N1 Number Analyzed 460 participants 450 participants
2.97
(2.652 to 3.329)
2.78
(2.501 to 3.094)
H3N2 Number Analyzed 460 participants 450 participants
8.42
(7.525 to 9.421)
7.49
(6.669 to 8.414)
B BRISBANE Number Analyzed 460 participants 450 participants
2.53
(2.301 to 2.771)
2.24
(2.068 to 2.425)
B PHUKET Number Analyzed 460 participants 450 participants
2.63
(2.419 to 2.850)
2.40
(2.217 to 2.589)
8.Secondary Outcome
Title Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody
Hide Description 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.
Time Frame Day 29 of Season 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 464 451
Measure Type: Number
Unit of Measure: Percentage of Participants
H1N1 Number Analyzed 460 participants 450 participants
32.6 32.4
H3N2 Number Analyzed 460 participants 450 participants
76.5 74.2
B BRISBANE Number Analyzed 460 participants 450 participants
31.7 26.9
B PHUKET Number Analyzed 460 participants 450 participants
33.0 30.2
9.Secondary Outcome
Title Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay
Hide Description 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.
Time Frame Day 29 and End of Season 1 (approximately 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Post-dose Geometric Mean Fold Change of Serum Antibodies Against RSV by Microneutralization Assay
Hide Description 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.
Time Frame Day 29 and End of Season 1 (approximately 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Percentage of Participants Who Had a Post-dose Seroresponse to RSV by Microneutralization Assay
Hide Description 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.
Time Frame Day 29 and End of Season 1 (approximately 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Post-dose Geometric Mean Concentration (GMC) of Palivizumab Competitive Antibodies as Measured by a Palivizumab Competitive Enzyme Linked Immunosorbent Assay (cELISA)
Hide Description 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.
Time Frame Day 29 and End of Season 1 (approximately 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Post-dose Geometric Mean Fold Change of Palivizumab Competitive Antibodies as Measured by a Palivizumab cELISA
Hide Description 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.
Time Frame Day 29 and End of Season 1 (approximately 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by a Palivizumab cELISA
Hide Description 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.
Time Frame Day 29 and End of Season 1 (approximately 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Number of Participants With Any Solicited Symptoms
Hide Description 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.
Time Frame Day 1 (post-dose) through Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 948 946
Measure Type: Count of Participants
Unit of Measure: Participants
558
  58.9%
606
  64.1%
16.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events
Hide Description 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.
Time Frame Day 1 (post-dose) through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 948 946
Measure Type: Count of Participants
Unit of Measure: Participants
141
  14.9%
146
  15.4%
17.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Day 1 (post-dose) through end of Season 1 (approximately 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo + IIV MEDI7510 + IIV
Hide Arm/Group Description:
Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Overall Number of Participants Analyzed 948 946
Measure Type: Count of Participants
Unit of Measure: Participants
TEAESIs
0
   0.0%
1
   0.1%
TESAEs
3
   0.3%
4
   0.4%
NOCDs
5
   0.5%
4
   0.4%
Time Frame Day 1 (post-dose) through end of Season 1 (approximately 1 year)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo + IIV MEDI7510+IIV
Hide Arm/Group Description Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm. Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
All-Cause Mortality
Placebo + IIV MEDI7510+IIV
Affected / at Risk (%) Affected / at Risk (%)
Total   5/948 (0.53%)      3/946 (0.32%)    
Hide Serious Adverse Events
Placebo + IIV MEDI7510+IIV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   57/948 (6.01%)      64/946 (6.77%)    
Blood and lymphatic system disorders     
Anaemia † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Febrile neutropenia † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Haemorrhagic diathesis † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Cardiac disorders     
Acute myocardial infarction † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Angina pectoris † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Angina unstable † 1  2/948 (0.21%)  2 2/946 (0.21%)  2
Arrhythmia † 1  2/948 (0.21%)  2 0/946 (0.00%)  0
Atrial fibrillation † 1  0/948 (0.00%)  0 4/946 (0.42%)  5
Bradyarrhythmia † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Cardiac arrest † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Cardiac failure acute † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Cardiac failure congestive † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Coronary artery disease † 1  1/948 (0.11%)  1 2/946 (0.21%)  2
Myocardial infarction † 1  6/948 (0.63%)  7 1/946 (0.11%)  1
Endocrine disorders     
Goitre † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Eye disorders     
Glaucoma † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Gastrointestinal disorders     
Abdominal pain † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Colitis † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Gastric ulcer haemorrhage † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Gastrointestinal haemorrhage † 1  1/948 (0.11%)  1 1/946 (0.11%)  1
Pancreatitis † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Pancreatitis relapsing † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Small intestinal obstruction † 1  0/948 (0.00%)  0 2/946 (0.21%)  2
Small intestinal perforation † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Upper gastrointestinal haemorrhage † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
General disorders     
Death † 1  2/948 (0.21%)  2 1/946 (0.11%)  1
Non-cardiac chest pain † 1  1/948 (0.11%)  1 1/946 (0.11%)  1
Hepatobiliary disorders     
Bile duct stone † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Cholecystitis † 1  1/948 (0.11%)  1 1/946 (0.11%)  1
Infections and infestations     
Abscess limb † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Appendicitis † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Bronchitis † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Cellulitis † 1  1/948 (0.11%)  1 1/946 (0.11%)  1
Device related infection † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Diverticulitis † 1  1/948 (0.11%)  1 1/946 (0.11%)  1
Epididymitis † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Helicobacter infection † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Infected lymphocele † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Localised infection † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Osteomyelitis † 1  1/948 (0.11%)  1 1/946 (0.11%)  1
Pneumonia † 1  3/948 (0.32%)  3 0/946 (0.00%)  0
Pneumonia influenzal † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Sepsis † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Septic shock † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Tracheobronchitis † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Urinary tract infection † 1  2/948 (0.21%)  2 0/946 (0.00%)  0
Wound infection † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Injury, poisoning and procedural complications     
Craniocerebral injury † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Femur fracture † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Foot fracture † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Hip fracture † 1  1/948 (0.11%)  1 1/946 (0.11%)  1
Humerus fracture † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Joint dislocation † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Multiple fractures † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Overdose † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Traumatic fracture † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Metabolism and nutrition disorders     
Dehydration † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Hyperglycaemia † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  0/948 (0.00%)  0 2/946 (0.21%)  2
Muscle spasms † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Osteoarthritis † 1  5/948 (0.53%)  5 2/946 (0.21%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Bladder cancer † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Colorectal cancer † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Invasive ductal breast carcinoma † 1  3/948 (0.32%)  3 0/946 (0.00%)  0
Invasive lobular breast carcinoma † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Lung adenocarcinoma metastatic † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Non-hodgkin's lymphoma † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Ovarian cancer metastatic † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Papillary thyroid cancer † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Peritoneal neoplasm † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Prostate cancer † 1  1/948 (0.11%)  1 2/946 (0.21%)  2
Prostate cancer metastatic † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Prostate cancer stage i † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Renal cancer † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Squamous cell carcinoma of head and neck † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Nervous system disorders     
Brain stem infarction † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Cerebrovascular accident † 1  3/948 (0.32%)  3 0/946 (0.00%)  0
Embolic stroke † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Syncope † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Transient ischaemic attack † 1  3/948 (0.32%)  3 0/946 (0.00%)  0
Product Issues     
Device dislocation † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Device failure † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Psychiatric disorders     
Anxiety † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Drug dependence † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Renal and urinary disorders     
Acute kidney injury † 1  0/948 (0.00%)  0 2/946 (0.21%)  2
End stage renal disease † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Haematuria † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Nephrolithiasis † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Uterine prolapse † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure † 1  1/948 (0.11%)  2 1/946 (0.11%)  1
Asthma † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Chronic obstructive pulmonary disease † 1  1/948 (0.11%)  2 0/946 (0.00%)  0
Hypoxia † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Interstitial lung disease † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Nasal septum deviation † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Pulmonary embolism † 1  2/948 (0.21%)  2 0/946 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin ulcer † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Vascular disorders     
Aortic occlusion † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Aortic stenosis † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Arteriosclerosis † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Deep vein thrombosis † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Hypertension † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Hypertensive crisis † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Hypertensive emergency † 1  0/948 (0.00%)  0 1/946 (0.11%)  1
Peripheral artery occlusion † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
Peripheral vascular disorder † 1  1/948 (0.11%)  1 0/946 (0.00%)  0
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo + IIV MEDI7510+IIV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/948 (5.49%)      48/946 (5.07%)    
General disorders     
Fatigue † 1  11/948 (1.16%)  13 16/946 (1.69%)  19
Injection site pain † 1  18/948 (1.90%)  35 10/946 (1.06%)  28
Infections and infestations     
Upper respiratory tract infection † 1  10/948 (1.05%)  10 16/946 (1.69%)  16
Viral upper respiratory tract infection † 1  10/948 (1.05%)  10 13/946 (1.37%)  13
Nervous system disorders     
Headache † 1  13/948 (1.37%)  15 10/946 (1.06%)  11
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
The study was terminated due to failure to meet the primary efficacy endpoint.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Judith Falloon, MD
Organization: MedImmune, LLC
Phone: 301-398-0000
EMail: clinicaltrialenquiries@medimmune.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02508194    
Other Study ID Numbers: D4420C00005
First Submitted: July 22, 2015
First Posted: July 24, 2015
Results First Submitted: August 7, 2017
Results First Posted: December 20, 2017
Last Update Posted: December 26, 2017