Overview

This trial is active, not recruiting.

Condition respiratory syncytial virus (rsv)
Treatments medi7510, iiv, placebo
Phase phase 2
Sponsor MedImmune LLC
Start date September 2015
End date August 2016
Trial size 1900 participants
Trial identifier NCT02508194, D4420C00005

Summary

This study will be the first assessment of the efficacy of MEDI7510 for the prevention of 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 subjects dosed with MEDI7510. The study will also assess the immune response to MEDI7510 in Season 1 and Season 2.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
MEDI7510 as a single IM injection in one arm and IIV as a single IM injection in the other arm
medi7510
RSV sF antigen plus adjuvant
iiv
Marketed Inactivated Influenza Vaccine
(Placebo Comparator)
Saline placebo as a single IM injection in one arm and IIV as a single IM injection in the other arm
iiv
Marketed Inactivated Influenza Vaccine
placebo
Sterile Saline

Primary Outcomes

Measure
The incidence of the first episode of acute RSV associated respiratory illness (ARA-RI) observed during the surveillance period in Season 1.
time frame: Day 14 after dosing through End of RSV Season 1 visit

Secondary Outcomes

Measure
The occurrence of all solicited symptoms
time frame: Day 1 (dosing) through Day 7
The incidence of RSV PCR-positive respiratory illness during the RSV surveillance period in Season 1.
time frame: Day 14 after dosing through Final RSV Season 1 visit
The post-dose geometric mean titers (GMTs) and geometric mean fold rises (GMFRs) from baseline of strain-specific hemagglutination inhibition (HAI) antibodies to influenza antigens contained in the seasonal influenza vaccine.
time frame: Day 1 (dosing) through Day 29
Measuring the immune response to MEDI7510 in Seasons 1 and 2 in the RSV immunogenicity subset.
time frame: Day 1 (dosing) through last contact Season 2
The occurrence of treatment-emergent adverse events
time frame: Day 1 dosing through Day 29 visit
The occurrence of treatment-emergent serious adverse events, new onset chronic disease and adverse events of special interest
time frame: Day 1 (dosing) through Final Contact.

Eligibility Criteria

Male or female participants from 60 years up to 99 years old.

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 in the 90 days prior to randomization or expected receipt of investigational product 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 AE including Grade 3 or 4 local reaction to either MEDI7510 or IIV, any AESI for an adjuvanted vaccine, or any related SAE.

Additional Information

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
Description A Phase 2b, double-blind, randomized, controlled study to evaluate the efficacy of MEDI7510 in approximately 1,900 adult subjects, globally, 60 years or older. Subjects 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. Subjects 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by MedImmune LLC.