A Study to Evaluate the Efficacy of MEDI7510 in Older Adults

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02508194
• Collaborator: (none)
• Enrollment: 1,900
• Locations: 61
• Arms: 2
• Actual Duration (Months): 13.3
• Patients Per Site: 31.1
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

This study will be the first assessment of the efficacy of MEDI7510 for the prevention of respiratory syncytial virus (RSV) disease. It will also provide estimates of vaccine efficacy and of endpoint incidence in the placebo arm. It will also assess the safety and immunogenicity of concurrent dosing of MEDI7510 and IIV to expand on the observations made in the Phase 1b study of MEDI7510. It will also expand the safety database of participants dosed with MEDI7510. The study will also assess the immune response to MEDI7510 in Season 1 and Season 2.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus	Biological: MEDI7510; Biological: IIV; Other: Placebo	Phase 2

Detailed Description

A Phase 2b, double-blind, randomized, and controlled study to evaluate the efficacy of MEDI7510 in approximately 1,900 adult participants, globally, 60 years or older. Participants will be randomized in a 1:1 ratio to receive a single intramuscular dose of each of 2 study vaccines in contralateral arms: MEDI7510 + IIV or placebo + IIV in Season 1.

Participants who receive MEDI7510 in the Northern Hemisphere will be re-randomized and blinded in Season 2 to receive either MEDI7510 + IIV or placebo + IIV in a 1:1 ratio. Clinical efficacy will not be assessed in Season 2; however the safety of revaccination will be assessed in Season 2.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1900 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase 2b Randomized, Double-blind Study to Evaluate the Efficacy of MEDI7510 for the Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness in Older Adults
• Actual Study Start Date: Sep 29, 2015
• Actual Primary Completion Date: Sep 9, 2016
• Actual Study Completion Date: Nov 7, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Biological: IIV; Marketed Inactivated Influenza Vaccine; Other: Placebo; Sterile Saline
Experimental: MEDI7510 + IIV Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.	Biological: MEDI7510; RSV soluble fusion protein (sF) antigen plus glucopyranosyl lipid A in stable emulsion (GLA-SE) adjuvant; Biological: IIV; Marketed Inactivated Influenza Vaccine

Outcome Measures

Primary Outcome Measures

1. 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 [Day 14 after dosing through end of surveillance period (approximately 7 months)]

   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.

Secondary Outcome Measures

1. Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1 [Day 14 after dosing through end of surveillance period (approximately 7 months)]

   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.

2. Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay [Day 1, Day 29, and End of Season 1 (approximately 1 year)]

   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.

3. Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay [Day 29 and End of Season 1 (approximately 1 year)]

   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.

4. Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay [Day 29 and End of Season 1 (approximately 1 year)]

   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.

5. Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine [Day 1 (post-dose) and Day 29 of Season 1]

   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.

6. Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine [Day 29 of Season 1]

   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.

7. Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody [Day 29 of Season 1]

   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.

8. Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay [Day 29 and End of Season 1 (approximately 1 year)]

   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.

9. Post-dose Geometric Mean Fold Change of Serum Antibodies Against RSV by Microneutralization Assay [Day 29 and End of Season 1 (approximately 1 year)]

   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.

10. Percentage of Participants Who Had a Post-dose Seroresponse to RSV by Microneutralization Assay [Day 29 and End of Season 1 (approximately 1 year)]

    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.

11. Post-dose Geometric Mean Concentration (GMC) of Palivizumab Competitive Antibodies as Measured by a Palivizumab Competitive Enzyme Linked Immunosorbent Assay (cELISA) [Day 29 and End of Season 1 (approximately 1 year)]

    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.

12. Post-dose Geometric Mean Fold Change of Palivizumab Competitive Antibodies as Measured by a Palivizumab cELISA [Day 29 and End of Season 1 (approximately 1 year)]

    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.

13. Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by a Palivizumab cELISA [Day 29 and End of Season 1 (approximately 1 year)]

    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.

14. Number of Participants With Any Solicited Symptoms [Day 1 (post-dose) through Day 7]

    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.

15. Number of Participants With Treatment-Emergent Adverse Events [Day 1 (post-dose) through Day 29]

    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.

16. 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) [Day 1 (post-dose) through end of Season 1 (approximately 1 year)]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age ≥ 60 years at the time of screening.

• Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the subject appears likely to be able to remain in follow-up through the end of protocol-specified follow-up.

• (Season 2): Subject received MEDI7510 and IIV in the Northern Hemisphere in Season 1.

Exclusion Criteria:

• History of allergy to any component of the vaccine.

• Receipt of seasonal influenza vaccine within 6 months prior to Season 1 dosing.

• History of allergy to or intolerance of IIV.

• Pregnancy or potential to become pregnant during the study. Females who (1) have had a menstrual period within the 12 months prior to study enrollment or (2) are undergoing any fertility treatment or who plan to undergo fertility treatments during the study period are excluded.

• History of Guillain-Barré syndrome.

• Previous vaccination against RSV.

• History of allergy to eggs in adulthood.

• History of or current autoimmune disorder, with the exception of stable, treated hypothyroidism caused by autoimmune thyroiditis, which is acceptable.

• Immunosuppression caused by disease, including human immunodeficiency virus infection (assessed by history), or medications. Any receipt of oral or intravenous glucocorticoid therapy within 30 days prior to enrollment or planned dosing within the follow-up period would disqualify. Topical, intranasal, inhaled, or intra-articular corticosteroids do not disqualify. Expected need for immunosuppressive medications during the follow-up period would disqualify.

• History of cancer within preceding 5 years other than treated non-melanoma skin cancer, locally-treated cervical cancer or in situ carcinoma of the breast.

• Receipt of any non-study vaccine within 28 days prior to study dosing or expected receipt of non-study vaccine prior to the Day 29 visit in Season 1.

• Receipt of any investigational product (IP) in the 90 days prior to randomization or expected receipt of IP during the period of study follow-up.

• Receipt of immunoglobulins or blood products within 4 months of study dosing (120 days) or expected receipt of immunoglobulins or blood products during the period of study follow-up.

• Current bleeding or clotting disorder including use of anticoagulants other than drugs with anti-platelet activity (such as nonsteroidal anti-inflammatory drugs, clopidogrel, ticagrelor or aspirin).

• History of alcohol or drug abuse or psychiatric disorder that, in the opinion of the investigator, would affect the subject's safety or compliance with study.

• (Season 2): Related Grade 3 or 4 adverse event (AE) including Grade 3 or 4 local reaction to either MEDI7510 or IIV, any adverse event of special interest (AESI) for an adjuvanted vaccine, or any related serious adverse event (SAE).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Sacramento	California	United States	95864
2	Research Site	San Francisco	California	United States	94108
3	Research Site	Aurora	Colorado	United States	80045
4	Research Site	Littleton	Colorado	United States	80127
5	Research Site	Lady Lake	Florida	United States	32159
6	Research Site	Miami	Florida	United States	33143
7	Research Site	Orlando	Florida	United States	32806
8	Research Site	Savannah	Georgia	United States	31406
9	Research Site	Champaign	Illinois	United States	61820
10	Research Site	Chicago	Illinois	United States	60654
11	Research Site	Council Bluffs	Iowa	United States	51503
12	Research Site	Augusta	Kansas	United States	67010
13	Research Site	Wichita	Kansas	United States	67205
14	Research Site	Edina	Minnesota	United States	55435
15	Research Site	Cincinnati	Missouri	United States	45249
16	Research Site	Kansas City	Missouri	United States	64114
17	Research Site	Bellevue	Nebraska	United States	68005
18	Research Site	Norfolk	Nebraska	United States	68701
19	Research Site	Omaha	Nebraska	United States	68134
20	Research Site	Rochester	New York	United States	14621
21	Research Site	Charlotte	North Carolina	United States	28209
22	Research Site	Hickory	North Carolina	United States	28602
23	Research Site	Raleigh	North Carolina	United States	27609
24	Research Site	Rocky Mount	North Carolina	United States	27804
25	Research Site	Winston-Salem	North Carolina	United States	27103
26	Research Site	Akron	Ohio	United States	44311
27	Research Site	Dakota Dunes	South Dakota	United States	57049
28	Research Site	Knoxville	Tennessee	United States	37912
29	Research Site	Nashville	Tennessee	United States	37212
30	Research Site	Murray	Utah	United States	84123
31	Research Site	Brampton	Ontario	Canada	L6T 0G1
32	Research Site	London	Ontario	Canada	N5W 6A2
33	Research Site	Newmarket	Ontario	Canada	L3Y 5G8
34	Research Site	Toronto	Ontario	Canada	M9V 4B4
35	Research Site	Toronto	Ontario	Canada	M9W 4L6
36	Research Site	Quebec		Canada	G1W 4R4
37	Research Site	Santiago		Chile	7500701
38	Research Site	Santiago		Chile	8700000
39	Research Site	Santiago		Chile	9340000
40	Research Site	Santiago		Chile	9350079
41	Research Site	Temuco		Chile	4781156
42	Research Site	Paide		Estonia	72713
43	Research Site	Tallinn		Estonia	10117
44	Research Site	Tallinn		Estonia	10128
45	Research Site	Tallinn		Estonia	10617
46	Research Site	Daugavpils		Latvia	LV-5401
47	Research Site	Jelgava		Latvia	LV-3001
48	Research Site	Kuldiga		Latvia	LV-3301
49	Research Site	Kaunas		Lithuania	49449
50	Research Site	Kaunas		Lithuania	LT-48259
51	Research Site	Kaunas		Lithuania	LT50009
52	Research Site	Vilnius		Lithuania	08661
53	Research Site	Vilnius		Lithuania	LT-01117
54	Research Site	Bellville		South Africa	7530
55	Research Site	Bloemfontein		South Africa	9301
56	Research Site	Cape Town		South Africa	7500
57	Research Site	Johannesburg		South Africa	1818
58	Research Site	Johannesburg		South Africa	2113
59	Research Site	Krugersdorp		South Africa	1739
60	Research Site	Pretoria		South Africa	184
61	Research Site	Somerset West		South Africa	7130

Sponsors and Collaborators

• MedImmune LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MedImmune LLC
• ClinicalTrials.gov Identifier: NCT02508194
• Other Study ID Numbers: D4420C00005
• First Posted: Jul 24, 2015
• Last Update Posted: Dec 26, 2017
• Last Verified: Dec 1, 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by MedImmune LLC: RSV; Older adults; MEDI7510; Vaccine; Efficacy

Study Results

Participant Flow

Recruitment Details	A total of 1900 participants were randomized and participated in the study at 60 sites in 7 countries.
Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Placebo + IIV	MEDI7510 + IIV	Total
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 Participants	949	951	1900
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	68.1 (6.2)	68.1 (6.3)	68.1 (6.2)
Sex: Female, Male (Count of Participants)
Female	587 61.9%	530 55.7%	1117 58.8%
Male	362 38.1%	421 44.3%	783 41.2%

Outcome Measures

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
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)

Outcome Measure Data

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
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.
Measure Participants	935	931
Number [Percentage of Participants]	1.6 0.2%	1.7 0.2%

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	-7.1
	Confidence Interval	(2-Sided) 90%; -106.9 to 44.3
	Parameter Dispersion	Type: Value:
	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
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)

Outcome Measure Data

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
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.
Measure Participants	935	931
Number [Percentage of Participants]	1.6 0.2%	1.7 0.2%

3. Secondary Outcome

Title	Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
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)

Outcome Measure Data

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
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.
Measure Participants	947	946
Day 1	83.39	77.96
Day 29	80.05	999.03
End of Season 1	79.95	370.88

4. Secondary Outcome

Title	Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay
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)

Outcome Measure Data

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
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.
Measure Participants	947	946
Day 29	0.96	12.78
End of Season 1	0.94	4.60

5. Secondary Outcome

Title	Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay
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)

Outcome Measure Data

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
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.
Measure Participants	947	946
Day 29	0.8 0.1%	92.9 9.8%
End of Season 1	1.6 0.2%	65.8 6.9%

6. Secondary Outcome

Title	Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
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

Outcome Measure Data

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
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.
Measure Participants	464	451
H1N1, Day 1	54.26	55.77
H1N1, Day 29	161.26	155.14
H3N2, Day 1	34.81	35.99
H3N2, Day 29	291.73	269.58
B BRISBANE, Day 1	12.89	13.46
B BRISBANE, Day 29	32.49	30.15
B PHUKET, Day 1	11.42	11.81
B PHUKET, Day 29	30.00	28.29

7. Secondary Outcome

Title	Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
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

Outcome Measure Data

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
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.
Measure Participants	464	451
H1N1	2.97	2.78
H3N2	8.42	7.49
B BRISBANE	2.53	2.24
B PHUKET	2.63	2.40

8. Secondary Outcome

Title	Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody
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

Outcome Measure Data

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
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.
Measure Participants	464	451
H1N1	32.6 3.4%	32.4 3.4%
H3N2	76.5 8.1%	74.2 7.8%
B BRISBANE	31.7 3.3%	26.9 2.8%
B PHUKET	33.0 3.5%	30.2 3.2%

9. Secondary Outcome

Title	Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay
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)

Outcome Measure Data

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
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.
Measure Participants	0	0

10. Secondary Outcome

Title	Post-dose Geometric Mean Fold Change of Serum Antibodies Against RSV by Microneutralization Assay
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)

Outcome Measure Data

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
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.
Measure Participants	0	0

11. Secondary Outcome

Title	Percentage of Participants Who Had a Post-dose Seroresponse to RSV by Microneutralization Assay
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)

Outcome Measure Data

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
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.
Measure Participants	0	0

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)
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)

Outcome Measure Data

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
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.
Measure Participants	0	0

13. Secondary Outcome

Title	Post-dose Geometric Mean Fold Change of Palivizumab Competitive Antibodies as Measured by a Palivizumab cELISA
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)

Outcome Measure Data

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
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.
Measure Participants	0	0

14. Secondary Outcome

Title	Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by a Palivizumab cELISA
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)

Outcome Measure Data

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
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.
Measure Participants	0	0

15. Secondary Outcome

Title	Number of Participants With Any Solicited Symptoms
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

Outcome Measure Data

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
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.
Measure Participants	948	946
Count of Participants [Participants]	558 58.8%	606 63.7%

16. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events
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

Outcome Measure Data

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
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.
Measure Participants	948	946
Count of Participants [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)
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)

Outcome Measure Data

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
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.
Measure Participants	948	946
TEAESIs	0 0%	1 0.1%
TESAEs	3 0.3%	4 0.4%
NOCDs	5 0.5%	4 0.4%

Adverse Events

Time Frame	Day 1 (post-dose) through end of Season 1 (approximately 1 year)
Arm/Group Title	Placebo + IIV		MEDI7510+IIV
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	5/948 (0.5%)		3/946 (0.3%)
Serious Adverse Events
	Placebo + IIV		MEDI7510+IIV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	57/948 (6%)		64/946 (6.8%)
Blood and lymphatic system disorders
Anaemia	1/948 (0.1%)	1	0/946 (0%)	0
Febrile neutropenia	1/948 (0.1%)	1	0/946 (0%)	0
Haemorrhagic diathesis	0/948 (0%)	0	1/946 (0.1%)	1
Cardiac disorders
Acute myocardial infarction	0/948 (0%)	0	1/946 (0.1%)	1
Angina pectoris	0/948 (0%)	0	1/946 (0.1%)	1
Angina unstable	2/948 (0.2%)	2	2/946 (0.2%)	2
Arrhythmia	2/948 (0.2%)	2	0/946 (0%)	0
Atrial fibrillation	0/948 (0%)	0	4/946 (0.4%)	5
Bradyarrhythmia	0/948 (0%)	0	1/946 (0.1%)	1
Cardiac arrest	0/948 (0%)	0	1/946 (0.1%)	1
Cardiac failure acute	1/948 (0.1%)	1	0/946 (0%)	0
Cardiac failure congestive	0/948 (0%)	0	1/946 (0.1%)	1
Coronary artery disease	1/948 (0.1%)	1	2/946 (0.2%)	2
Myocardial infarction	6/948 (0.6%)	7	1/946 (0.1%)	1
Endocrine disorders
Goitre	1/948 (0.1%)	1	0/946 (0%)	0
Eye disorders
Glaucoma	0/948 (0%)	0	1/946 (0.1%)	1
Gastrointestinal disorders
Abdominal pain	0/948 (0%)	0	1/946 (0.1%)	1
Colitis	0/948 (0%)	0	1/946 (0.1%)	1
Gastric ulcer haemorrhage	0/948 (0%)	0	1/946 (0.1%)	1
Gastrointestinal haemorrhage	1/948 (0.1%)	1	1/946 (0.1%)	1
Pancreatitis	0/948 (0%)	0	1/946 (0.1%)	1
Pancreatitis relapsing	0/948 (0%)	0	1/946 (0.1%)	1
Small intestinal obstruction	0/948 (0%)	0	2/946 (0.2%)	2
Small intestinal perforation	0/948 (0%)	0	1/946 (0.1%)	1
Upper gastrointestinal haemorrhage	0/948 (0%)	0	1/946 (0.1%)	1
General disorders
Death	2/948 (0.2%)	2	1/946 (0.1%)	1
Non-cardiac chest pain	1/948 (0.1%)	1	1/946 (0.1%)	1
Hepatobiliary disorders
Bile duct stone	0/948 (0%)	0	1/946 (0.1%)	1
Cholecystitis	1/948 (0.1%)	1	1/946 (0.1%)	1
Infections and infestations
Abscess limb	0/948 (0%)	0	1/946 (0.1%)	1
Appendicitis	0/948 (0%)	0	1/946 (0.1%)	1
Bronchitis	1/948 (0.1%)	1	0/946 (0%)	0
Cellulitis	1/948 (0.1%)	1	1/946 (0.1%)	1
Device related infection	0/948 (0%)	0	1/946 (0.1%)	1
Diverticulitis	1/948 (0.1%)	1	1/946 (0.1%)	1
Epididymitis	0/948 (0%)	0	1/946 (0.1%)	1
Helicobacter infection	0/948 (0%)	0	1/946 (0.1%)	1
Infected lymphocele	0/948 (0%)	0	1/946 (0.1%)	1
Localised infection	0/948 (0%)	0	1/946 (0.1%)	1
Osteomyelitis	1/948 (0.1%)	1	1/946 (0.1%)	1
Pneumonia	3/948 (0.3%)	3	0/946 (0%)	0
Pneumonia influenzal	1/948 (0.1%)	1	0/946 (0%)	0
Sepsis	0/948 (0%)	0	1/946 (0.1%)	1
Septic shock	0/948 (0%)	0	1/946 (0.1%)	1
Tracheobronchitis	1/948 (0.1%)	1	0/946 (0%)	0
Urinary tract infection	2/948 (0.2%)	2	0/946 (0%)	0
Wound infection	0/948 (0%)	0	1/946 (0.1%)	1
Injury, poisoning and procedural complications
Craniocerebral injury	1/948 (0.1%)	1	0/946 (0%)	0
Femur fracture	0/948 (0%)	0	1/946 (0.1%)	1
Foot fracture	1/948 (0.1%)	1	0/946 (0%)	0
Hip fracture	1/948 (0.1%)	1	1/946 (0.1%)	1
Humerus fracture	0/948 (0%)	0	1/946 (0.1%)	1
Joint dislocation	0/948 (0%)	0	1/946 (0.1%)	1
Multiple fractures	1/948 (0.1%)	1	0/946 (0%)	0
Overdose	1/948 (0.1%)	1	0/946 (0%)	0
Traumatic fracture	0/948 (0%)	0	1/946 (0.1%)	1
Metabolism and nutrition disorders
Dehydration	0/948 (0%)	0	1/946 (0.1%)	1
Hyperglycaemia	1/948 (0.1%)	1	0/946 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/948 (0%)	0	2/946 (0.2%)	2
Muscle spasms	1/948 (0.1%)	1	0/946 (0%)	0
Osteoarthritis	5/948 (0.5%)	5	2/946 (0.2%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon	1/948 (0.1%)	1	0/946 (0%)	0
Bladder cancer	0/948 (0%)	0	1/946 (0.1%)	1
Colorectal cancer	0/948 (0%)	0	1/946 (0.1%)	1
Invasive ductal breast carcinoma	3/948 (0.3%)	3	0/946 (0%)	0
Invasive lobular breast carcinoma	0/948 (0%)	0	1/946 (0.1%)	1
Lung adenocarcinoma metastatic	0/948 (0%)	0	1/946 (0.1%)	1
Non-hodgkin's lymphoma	1/948 (0.1%)	1	0/946 (0%)	0
Ovarian cancer metastatic	1/948 (0.1%)	1	0/946 (0%)	0
Papillary thyroid cancer	0/948 (0%)	0	1/946 (0.1%)	1
Peritoneal neoplasm	0/948 (0%)	0	1/946 (0.1%)	1
Prostate cancer	1/948 (0.1%)	1	2/946 (0.2%)	2
Prostate cancer metastatic	1/948 (0.1%)	1	0/946 (0%)	0
Prostate cancer stage i	0/948 (0%)	0	1/946 (0.1%)	1
Renal cancer	0/948 (0%)	0	1/946 (0.1%)	1
Squamous cell carcinoma of head and neck	1/948 (0.1%)	1	0/946 (0%)	0
Nervous system disorders
Brain stem infarction	0/948 (0%)	0	1/946 (0.1%)	1
Cerebrovascular accident	3/948 (0.3%)	3	0/946 (0%)	0
Embolic stroke	0/948 (0%)	0	1/946 (0.1%)	1
Syncope	1/948 (0.1%)	1	0/946 (0%)	0
Transient ischaemic attack	3/948 (0.3%)	3	0/946 (0%)	0
Product Issues
Device dislocation	0/948 (0%)	0	1/946 (0.1%)	1
Device failure	0/948 (0%)	0	1/946 (0.1%)	1
Psychiatric disorders
Anxiety	0/948 (0%)	0	1/946 (0.1%)	1
Drug dependence	0/948 (0%)	0	1/946 (0.1%)	1
Renal and urinary disorders
Acute kidney injury	0/948 (0%)	0	2/946 (0.2%)	2
End stage renal disease	0/948 (0%)	0	1/946 (0.1%)	1
Haematuria	1/948 (0.1%)	1	0/946 (0%)	0
Nephrolithiasis	1/948 (0.1%)	1	0/946 (0%)	0
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/948 (0.1%)	1	0/946 (0%)	0
Uterine prolapse	0/948 (0%)	0	1/946 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/948 (0.1%)	2	1/946 (0.1%)	1
Asthma	1/948 (0.1%)	1	0/946 (0%)	0
Chronic obstructive pulmonary disease	1/948 (0.1%)	2	0/946 (0%)	0
Hypoxia	0/948 (0%)	0	1/946 (0.1%)	1
Interstitial lung disease	0/948 (0%)	0	1/946 (0.1%)	1
Nasal septum deviation	1/948 (0.1%)	1	0/946 (0%)	0
Pulmonary embolism	2/948 (0.2%)	2	0/946 (0%)	0
Skin and subcutaneous tissue disorders
Skin ulcer	1/948 (0.1%)	1	0/946 (0%)	0
Vascular disorders
Aortic occlusion	0/948 (0%)	0	1/946 (0.1%)	1
Aortic stenosis	0/948 (0%)	0	1/946 (0.1%)	1
Arteriosclerosis	1/948 (0.1%)	1	0/946 (0%)	0
Deep vein thrombosis	0/948 (0%)	0	1/946 (0.1%)	1
Hypertension	1/948 (0.1%)	1	0/946 (0%)	0
Hypertensive crisis	0/948 (0%)	0	1/946 (0.1%)	1
Hypertensive emergency	0/948 (0%)	0	1/946 (0.1%)	1
Peripheral artery occlusion	1/948 (0.1%)	1	0/946 (0%)	0
Peripheral vascular disorder	1/948 (0.1%)	1	0/946 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo + IIV		MEDI7510+IIV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	52/948 (5.5%)		48/946 (5.1%)
General disorders
Fatigue	11/948 (1.2%)	13	16/946 (1.7%)	19
Injection site pain	18/948 (1.9%)	35	10/946 (1.1%)	28
Infections and infestations
Upper respiratory tract infection	10/948 (1.1%)	10	16/946 (1.7%)	16
Viral upper respiratory tract infection	10/948 (1.1%)	10	13/946 (1.4%)	13
Nervous system disorders
Headache	13/948 (1.4%)	15	10/946 (1.1%)	11

Limitations/Caveats

The study was terminated due to failure to meet the primary efficacy endpoint.

More Information

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