A Study to Evaluate the Efficacy of MEDI7510 in Older Adults

Phase 1

• Conditions: Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness; MedDRA version: 18.0Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-002758-11-LT
• Lead Sponsor: MedImmune, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-06
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

Season 1
1. Age = 60 years at the time of screening.
2. Written informed consent and any locally required authorization (eg, Health Insurance
Portability and Accountability Act) obtained from the subject prior to performing any
protocol-related procedures, including screening evaluations.
3. 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.
4. Subject able to visit the clinic for study-specified visits and subject also available by
telephone.
5. Subject able to understand and comply with the requirements of the protocol.
6. Subject able to complete study follow-up period in Season 1 and, according to investigator judgment, reasonably likely to complete the study follow-up period in Season 2 if assigned.

Season 2
1. Subject received MEDI7510 + IIV in the Northern Hemisphere in Season 1.
2. Subject able to visit the clinic for study-specified visits and subject also available by
telephone.
3. Subject able to understand and comply with the requirements of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 570
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1330

Exclusion Criteria

Season 1
1. History of allergy to any component of the vaccine.
2. Receipt of seasonal influenza vaccine within 6 months prior to Season 1 dosing.
3. History of allergy to or intolerance of IIV.
4. Pregnancy or potential to become pregnant during the study.
5. History of Guillain-Barré syndrome.
6. Cognitive disorder such that informed consent cannot be obtained directly from the
subject.
7. Previous vaccination against RSV.
8. History of allergy to eggs in adulthood.
9. History of or current autoimmune disorder, with the exception of stable, treated hypothyroidism caused by autoimmune thyroiditis.
10. 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.
11. 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.
12. Significant infection or other acute illness, including fever = 100°F (= 37.8°C) on the day
prior to or day of randomization.
13. 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.
14. Receipt of any investigational product in the 90 days prior to randomization or expected
receipt of investigational product during the period of study follow-up.
15. 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.
16. 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).
17. Any condition that, in the opinion of the investigator, would interfere with evaluation of
the investigational product or interpretation of subject safety or study results.
18. 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
1. Related Grade 3 or 4 AE including Grade 3 or 4 local reaction to either MEDI7510 or
IIV, any AESI for an adjuvanted vaccine, or any related SAE.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of a single IM dose of MEDI7510 for the prevention of acute respiratory syncytial virus-associated respiratory illness (ARA-RI) in adults = 60 years of age in Season 1 of dosing.;Secondary Objective: 1. To assess the safety and tolerability of MEDI7510 in Season 1 and Season 2<br>2. To assess the incidence of RSV polymerase chain reaction (PCR)-positive respiratory<br>illness in Season 1<br>3. To assess the immunogenicity of inactivated influenza vaccine (IIV) administered alone<br>as compared to administered concurrently with MEDI7510 in Season 1<br>4. To assess the immune response to MEDI7510 in Season 1 and Season 2;Primary end point(s): The incidence of the first episode of ARA-RI observed during the RSV surveillance period in<br>Season 1.;Timepoint(s) of evaluation of this end point: At least 14 days after vaccination and during the RSV surveillance period.