Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02508194
Other study ID # D4420C00005
Secondary ID
Status Terminated
Phase Phase 2
First received July 22, 2015
Last updated December 22, 2017
Start date September 29, 2015
Est. completion date November 7, 2016

Study information

Verified date December 2017
Source MedImmune LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1900
Est. completion date November 7, 2016
Est. primary completion date September 9, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 99 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
MEDI7510
RSV soluble fusion protein (sF) antigen plus glucopyranosyl lipid A in stable emulsion (GLA-SE) adjuvant
IIV
Marketed Inactivated Influenza Vaccine
Other:
Placebo
Sterile Saline

Locations

Country Name City State
Canada Research Site Brampton Ontario
Canada Research Site London Ontario
Canada Research Site Newmarket Ontario
Canada Research Site Quebec
Canada Research Site Toronto Ontario
Canada Research Site Toronto Ontario
Chile Research Site Santiago
Chile Research Site Santiago
Chile Research Site Santiago
Chile Research Site Santiago
Chile Research Site Temuco
Estonia Research Site Paide
Estonia Research Site Tallinn
Estonia Research Site Tallinn
Estonia Research Site Tallinn
Latvia Research Site Daugavpils
Latvia Research Site Jelgava
Latvia Research Site Kuldiga
Lithuania Research Site Kaunas
Lithuania Research Site Kaunas
Lithuania Research Site Kaunas
Lithuania Research Site Vilnius
Lithuania Research Site Vilnius
South Africa Research Site Bellville
South Africa Research Site Bloemfontein
South Africa Research Site Cape Town
South Africa Research Site Johannesburg
South Africa Research Site Johannesburg
South Africa Research Site Krugersdorp
South Africa Research Site Pretoria
South Africa Research Site Somerset West
United States Research Site Akron Ohio
United States Research Site Augusta Kansas
United States Research Site Aurora Colorado
United States Research Site Bellevue Nebraska
United States Research Site Champaign Illinois
United States Research Site Charlotte North Carolina
United States Research Site Chicago Illinois
United States Research Site Cincinnati Missouri
United States Research Site Council Bluffs Iowa
United States Research Site Dakota Dunes South Dakota
United States Research Site Edina Minnesota
United States Research Site Hickory North Carolina
United States Research Site Kansas City Missouri
United States Research Site Knoxville Tennessee
United States Research Site Lady Lake Florida
United States Research Site Littleton Colorado
United States Research Site Miami Florida
United States Research Site Murray Utah
United States Research Site Nashville Tennessee
United States Research Site Norfolk Nebraska
United States Research Site Omaha Nebraska
United States Research Site Orlando Florida
United States Research Site Raleigh North Carolina
United States Research Site Rochester New York
United States Research Site Rocky Mount North Carolina
United States Research Site Sacramento California
United States Research Site San Francisco California
United States Research Site Savannah Georgia
United States Research Site Wichita Kansas
United States Research Site Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Canada,  Chile,  Estonia,  Latvia,  Lithuania,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Day 14 after dosing through end of surveillance period (approximately 7 months)
Secondary Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1 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. Day 14 after dosing through end of surveillance period (approximately 7 months)
Secondary Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay 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. Day 1, Day 29, and End of Season 1 (approximately 1 year)
Secondary Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay 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. Day 29 and End of Season 1 (approximately 1 year)
Secondary Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay 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. Day 29 and End of Season 1 (approximately 1 year)
Secondary Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine GMT was calculated as: anti-log2 [mean (log2 xi)], where "xi" is an antibodies concentration of participants. GMTs of strain-Specific HAI antibodies (H1N1, H3N2, B Brisbane, and B Phuket) were reported. The Season 1 was approximately 1 year. Day 1 (post-dose) and Day 29 of Season 1
Secondary Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine Geometric mean fold change was calculated as: anti-log2 [mean (log2 yi)], where "yi" is the post dose antibody concentration or T-cell count fold change from baseline for each participant. Geometric mean fold change of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) were reported. The Season 1 was approximately 1 year. Day 29 of Season 1
Secondary Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody 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. Day 29 of Season 1
Secondary Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay 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. Day 29 and End of Season 1 (approximately 1 year)
Secondary Post-dose Geometric Mean Fold Change of Serum Antibodies Against RSV by Microneutralization Assay 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. Day 29 and End of Season 1 (approximately 1 year)
Secondary Percentage of Participants Who Had a Post-dose Seroresponse to RSV by Microneutralization Assay 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. Day 29 and End of Season 1 (approximately 1 year)
Secondary Post-dose Geometric Mean Concentration (GMC) of Palivizumab Competitive Antibodies as Measured by a Palivizumab Competitive Enzyme Linked Immunosorbent Assay (cELISA) 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. Day 29 and End of Season 1 (approximately 1 year)
Secondary Post-dose Geometric Mean Fold Change of Palivizumab Competitive Antibodies as Measured by a Palivizumab cELISA 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. Day 29 and End of Season 1 (approximately 1 year)
Secondary Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by a Palivizumab cELISA 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. Day 29 and End of Season 1 (approximately 1 year)
Secondary Number of Participants With Any Solicited Symptoms 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. Day 1 (post-dose) through Day 7
Secondary Number of Participants With Treatment-Emergent Adverse Events 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. Day 1 (post-dose) through Day 29
Secondary 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) 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. Day 1 (post-dose) through end of Season 1 (approximately 1 year)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04528719 - A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive Phase 1
Active, not recruiting NCT06060457 - A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age Phase 3
Terminated NCT01757496 - Cough Assist in Bronchiolitis N/A
Completed NCT00100373 - RSV Challenge in Healthy Adults N/A
Completed NCT03524118 - Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002) Phase 1/Phase 2
Active, not recruiting NCT05572658 - Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study
Recruiting NCT06067230 - A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults Phase 3
Completed NCT00246480 - RSV Disease in the Elderly
Active, not recruiting NCT06097299 - A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus Phase 2
Completed NCT00889070 - Respiratory Events Among Premature Infants N/A
Unknown status NCT00613184 - Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses N/A
Completed NCT05559905 - Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017) Phase 2
Active, not recruiting NCT05127434 - A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age Phase 2/Phase 3
Terminated NCT04978337 - A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection Phase 2
Recruiting NCT06143046 - A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers Phase 2
Active, not recruiting NCT05397223 - A Study of Modified mRNA Vaccines in Healthy Adults Phase 1
Completed NCT02472548 - A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine Phase 1
Completed NCT01734668 - Sofia RSV FIA Field Study N/A
Completed NCT01562938 - MEDI-557 Adult Dosing Phase 1
Recruiting NCT06325657 - A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants Phase 3