Respiratory Syncytial VirusPhase 2NCT02508194
A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
A Phase 2 study testing MEDI7510 and IIV in people with Respiratory Syncytial Virus, run by MedImmune LLC at 61 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- MEDI7510 and IIV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,900 participants
- Where
- 61 sitesin 7 countries
- Study dates
- 29 Sep 2015to 7 Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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).
Trial locations and contacts
61 sites in 7 countries.
61 sites in 7 countries
United States30 sites
Research Site
Akron, Ohio, 44311
Research Site
Augusta, Kansas, 67010
Research Site
Aurora, Colorado, 80045
Research Site
Bellevue, Nebraska, 68005
Research Site
Champaign, Illinois, 61820
Research Site
Charlotte, North Carolina, 28209
Research Site
Chicago, Illinois, 60654
Research Site
Cincinnati, Missouri, 45249
Research Site
Council Bluffs, Iowa, 51503
Research Site
Dakota Dunes, South Dakota, 57049
Research Site
Edina, Minnesota, 55435
Research Site
Hickory, North Carolina, 28602
Research Site
Kansas City, Missouri, 64114
Research Site
Knoxville, Tennessee, 37912
Research Site
Lady Lake, Florida, 32159
Research Site
Littleton, Colorado, 80127
Research Site
Miami, Florida, 33143
Research Site
Murray, Utah, 84123
Research Site
Nashville, Tennessee, 37212
Research Site
Norfolk, Nebraska, 68701
Research Site
Omaha, Nebraska, 68134
Research Site
Orlando, Florida, 32806
Research Site
Raleigh, North Carolina, 27609
Research Site
Rochester, New York, 14621
Research Site
Rocky Mount, North Carolina, 27804
Research Site
Sacramento, California, 95864
Research Site
San Francisco, California, 94108
Research Site
Savannah, Georgia, 31406
Research Site
Wichita, Kansas, 67205
Research Site
Winston-Salem, North Carolina, 27103
South Africa8 sites
Research Site
Bellville, 7530
Research Site
Bloemfontein, 9301
Research Site
Cape Town, 7500
Research Site
Johannesburg, 1818
Research Site
Johannesburg, 2113
Research Site
Krugersdorp, 1739
Research Site
Pretoria, 184
Research Site
Somerset West, 7130
Canada6 sites
Research Site
Brampton, Ontario, L6T 0G1
Research Site
London, Ontario, N5W 6A2
Research Site
Newmarket, Ontario, L3Y 5G8
Research Site
Québec, G1W 4R4
Research Site
Toronto, Ontario, M9V 4B4
Research Site
Toronto, Ontario, M9W 4L6
Chile5 sites
Research Site
Santiago, 7500701
Research Site
Santiago, 8700000
Research Site
Santiago, 9340000
Research Site
Santiago, 9350079
Research Site
Temuco, 4781156
Lithuania5 sites
Research Site
Kaunas, 49449
Research Site
Kaunas, LT-48259
Research Site
Kaunas, LT50009
Research Site
Vilnius, 08661
Research Site
Vilnius, LT-01117
Estonia4 sites
Research Site
Paide, 72713
Research Site
Tallinn, 10117
Research Site
Tallinn, 10128
Research Site
Tallinn, 10617
Latvia3 sites
Research Site
Daugavpils, LV-5401
Research Site
Jelgava, LV-3001
Research Site
Kuldīga, LV-3301
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- MEDI7510, IIV, Placebo
- Keywords
- RSV, Older adults, MEDI7510, Vaccine, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI7510Biological
RSV soluble fusion protein (sF) antigen plus glucopyranosyl lipid A in stable emulsion (GLA-SE) adjuvant
IIVBiological
Marketed Inactivated Influenza Vaccine
PlaceboOther
Sterile Saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Inactivated Influenza Vaccine (IIV) | Active comparator | 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. Receives: Biological: IIV; Other: Placebo |
| MEDI7510 + IIV | Experimental | Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm. Receives: Biological: MEDI7510; Biological: IIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14 after dosing through end of surveillance period (approximately 7 months)
Secondary outcomes (16)
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.
Measured: Day 14 after dosing through end of surveillance period (approximately 7 months)
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.
Measured: Day 1, Day 29, and End of Season 1 (approximately 1 year)
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.
Measured: Day 29 and End of Season 1 (approximately 1 year)
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.
Measured: Day 29 and End of Season 1 (approximately 1 year)
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.
Measured: Day 1 (post-dose) and Day 29 of Season 1
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.
Measured: Day 29 of Season 1
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.
Measured: Day 29 of Season 1
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.
Measured: Day 29 and End of Season 1 (approximately 1 year)
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.
Measured: Day 29 and End of Season 1 (approximately 1 year)
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.
Measured: Day 29 and End of Season 1 (approximately 1 year)
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.
Measured: Day 29 and End of Season 1 (approximately 1 year)
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.
Measured: Day 29 and End of Season 1 (approximately 1 year)
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.
Measured: Day 29 and End of Season 1 (approximately 1 year)
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.
Measured: Day 1 (post-dose) through Day 7
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.
Measured: Day 1 (post-dose) through Day 29
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.
Measured: Day 1 (post-dose) through end of Season 1 (approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study start29 Sep 2015
- Primary completion9 Sep 2016
- Study completion7 Nov 2016
Why it stopped: Year 1 of study completed. No enrollment planned for Year 2 of study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508194
- Sponsor's protocol ID
- D4420C00005
- Status last verified
- Dec 2017
- First submitted
- 22 Jul 2015
- Last updated
- 26 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chang LA, Phung E, Crank MC, Morabito KM, Villafana T, Dubovsky F, Falloon J, Esser MT, Lin BC, Chen GL, Graham BS, Ruckwardt TJ. A prefusion-stabilized RSV F subunit vaccine elicits B cell responses with greater breadth and potency than a postfusion F vaccine. Sci Transl Med. 2022 Dec 21;14(676):eade0424. doi: 10.1126/scitranslmed.ade0424. Epub 2022 Dec 21.
PubMed 36542692Falloon J, Yu J, Esser MT, Villafana T, Yu L, Dubovsky F, Takas T, Levin MJ, Falsey AR. An Adjuvanted, Postfusion F Protein-Based Vaccine Did Not Prevent Respiratory Syncytial Virus Illness in Older Adults. J Infect Dis. 2017 Dec 12;216(11):1362-1370. doi: 10.1093/infdis/jix503.
PubMed 29029260
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02508194
- Acronym / sponsor ID
- D4420C00005
- Conditions
- Respiratory Syncytial Virus
- Keywords
- RSV, Older adults, MEDI7510, Vaccine, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Year 1 of study completed. No enrollment planned for Year 2 of study.
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2015 (actual)
- Primary completion
- 9 Sep 2016 (actual)
- Study completion
- 7 Nov 2016 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Posted 20 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + Inactivated Influenza Vaccine (IIV) | Active comparator | Biological: IIV, Other: PlaceboParticipants received a single intramuscular (IM) injection of placebo (matched with MEDI7510) in one arm and single IM injection of (IIV) in the contralateral arm. |
| MEDI7510 + IIV | Experimental | Biological: MEDI7510, Biological: IIVParticipants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI7510RSV soluble fusion protein (sF) antigen plus glucopyranosyl lipid A in stable emulsion (GLA-SE) adjuvant | Biological | MEDI7510 + IIV |
| IIVMarketed Inactivated Influenza Vaccine | Biological | MEDI7510 + IIV, Placebo + Inactivated Influenza Vaccine (IIV) |
| PlaceboSterile Saline | Other | Placebo + Inactivated Influenza Vaccine (IIV) |
Primary outcome
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
Time frame: 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.
16 secondary outcomes
Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1
Time frame: Day 14 after dosing through end of surveillance period (approximately 7 months)
Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Time frame: Day 1, Day 29, and End of Season 1 (approximately 1 year)
Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay
Time frame: Day 29 and End of Season 1 (approximately 1 year)
Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay
Time frame: Day 29 and End of Season 1 (approximately 1 year)
Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
Time frame: Day 1 (post-dose) and Day 29 of Season 1
Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
Time frame: Day 29 of Season 1
Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody
Time frame: Day 29 of Season 1
Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay
Time frame: Day 29 and End of Season 1 (approximately 1 year)
Post-dose Geometric Mean Fold Change of Serum Antibodies Against RSV by Microneutralization Assay
Time frame: Day 29 and End of Season 1 (approximately 1 year)
Percentage of Participants Who Had a Post-dose Seroresponse to RSV by Microneutralization Assay
Time frame: Day 29 and End of Season 1 (approximately 1 year)
Post-dose Geometric Mean Concentration (GMC) of Palivizumab Competitive Antibodies as Measured by a Palivizumab Competitive Enzyme Linked Immunosorbent Assay (cELISA)
Time frame: Day 29 and End of Season 1 (approximately 1 year)
Post-dose Geometric Mean Fold Change of Palivizumab Competitive Antibodies as Measured by a Palivizumab cELISA
Time frame: Day 29 and End of Season 1 (approximately 1 year)
Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by a Palivizumab cELISA
Time frame: Day 29 and End of Season 1 (approximately 1 year)
Number of Participants With Any Solicited Symptoms
Time frame: Day 1 (post-dose) through Day 7
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Day 1 (post-dose) through Day 29
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)
Time frame: Day 1 (post-dose) through end of Season 1 (approximately 1 year)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36542692Chang LA, Phung E, Crank MC, Morabito KM, Villafana T, Dubovsky F, Falloon J, Esser MT, Lin BC, Chen GL, Graham BS, Ruckwardt TJ. A prefusion-stabilized RSV F subunit vaccine elicits B cell responses with greater breadth and potency than a postfusion F vaccine. Sci Transl Med. 2022 Dec 21;14(676):eade0424. doi: 10.1126/scitranslmed.ade0424. Epub 2022 Dec 21.
- Derived from this study: PubMed 29029260Falloon J, Yu J, Esser MT, Villafana T, Yu L, Dubovsky F, Takas T, Levin MJ, Falsey AR. An Adjuvanted, Postfusion F Protein-Based Vaccine Did Not Prevent Respiratory Syncytial Virus Illness in Older Adults. J Infect Dis. 2017 Dec 12;216(11):1362-1370. doi: 10.1093/infdis/jix503.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
61 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI7510 and IIV in people with Respiratory Syncytial Virus, run by MedImmune LLC at 61 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, South Africa, Canada, Chile, Lithuania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 14 after dosing through end of surveillance period (approximately 7 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02508194, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.