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Year 1 of study completed. No enrollment planned for Year 2 of study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| MEDI7510 + IIV | Experimental | Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI7510 | Biological | RSV soluble fusion protein (sF) antigen plus glucopyranosyl lipid A in stable emulsion (GLA-SE) adjuvant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Sacramento | California | 95864 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36542692 | Derived | 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. | |
| 29029260 |
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A total of 2,044 participants were screened, of which 144 participants were screen failures and 1900 participants were randomized in the study.
A total of 1900 participants were randomized and participated in the study at 60 sites in 7 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | MEDI7510 + IIV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| IIV | Biological | Marketed Inactivated Influenza Vaccine |
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| Placebo | Other | Sterile Saline |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 1 (post-dose) through end of Season 1 (approximately 1 year) |
| San Francisco |
| California |
| 94108 |
| United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Littleton | Colorado | 80127 | United States |
| Research Site | Lady Lake | Florida | 32159 | United States |
| Research Site | Miami | Florida | 33143 | United States |
| Research Site | Orlando | Florida | 32806 | United States |
| Research Site | Savannah | Georgia | 31406 | United States |
| Research Site | Champaign | Illinois | 61820 | United States |
| Research Site | Chicago | Illinois | 60654 | United States |
| Research Site | Council Bluffs | Iowa | 51503 | United States |
| Research Site | Augusta | Kansas | 67010 | United States |
| Research Site | Wichita | Kansas | 67205 | United States |
| Research Site | Edina | Minnesota | 55435 | United States |
| Research Site | Cincinnati | Missouri | 45249 | United States |
| Research Site | Kansas City | Missouri | 64114 | United States |
| Research Site | Bellevue | Nebraska | 68005 | United States |
| Research Site | Norfolk | Nebraska | 68701 | United States |
| Research Site | Omaha | Nebraska | 68134 | United States |
| Research Site | Rochester | New York | 14621 | United States |
| Research Site | Charlotte | North Carolina | 28209 | United States |
| Research Site | Hickory | North Carolina | 28602 | United States |
| Research Site | Raleigh | North Carolina | 27609 | United States |
| Research Site | Rocky Mount | North Carolina | 27804 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Akron | Ohio | 44311 | United States |
| Research Site | Dakota Dunes | South Dakota | 57049 | United States |
| Research Site | Knoxville | Tennessee | 37912 | United States |
| Research Site | Nashville | Tennessee | 37212 | United States |
| Research Site | Murray | Utah | 84123 | United States |
| Research Site | Brampton | Ontario | L6T 0G1 | Canada |
| Research Site | London | Ontario | N5W 6A2 | Canada |
| Research Site | Newmarket | Ontario | L3Y 5G8 | Canada |
| Research Site | Toronto | Ontario | M9V 4B4 | Canada |
| Research Site | Toronto | Ontario | M9W 4L6 | Canada |
| Research Site | Québec | G1W 4R4 | Canada |
| Research Site | Santiago | 7500701 | Chile |
| Research Site | Santiago | 8700000 | Chile |
| Research Site | Santiago | 9340000 | Chile |
| Research Site | Santiago | 9350079 | Chile |
| Research Site | Temuco | 4781156 | Chile |
| Research Site | Paide | 72713 | Estonia |
| Research Site | Tallinn | 10117 | Estonia |
| Research Site | Tallinn | 10128 | Estonia |
| Research Site | Tallinn | 10617 | Estonia |
| Research Site | Daugavpils | LV-5401 | Latvia |
| Research Site | Jelgava | LV-3001 | Latvia |
| Research Site | Kuldīga | LV-3301 | Latvia |
| Research Site | Kaunas | 49449 | Lithuania |
| Research Site | Kaunas | LT-48259 | Lithuania |
| Research Site | Kaunas | LT50009 | Lithuania |
| Research Site | Vilnius | 08661 | Lithuania |
| Research Site | Vilnius | LT-01117 | Lithuania |
| Research Site | Bellville | 7530 | South Africa |
| Research Site | Bloemfontein | 9301 | South Africa |
| Research Site | Cape Town | 7500 | South Africa |
| Research Site | Johannesburg | 1818 | South Africa |
| Research Site | Johannesburg | 2113 | South Africa |
| Research Site | Krugersdorp | 1739 | South Africa |
| Research Site | Pretoria | 184 | South Africa |
| Research Site | Somerset West | 7130 | South Africa |
| Falloon 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. |
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm. |
| COMPLETED |
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| NOT COMPLETED |
|
|
As-treated population (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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + IIV | Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm. |
| BG001 | MEDI7510 + IIV | Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | Percentage of Participants | Day 14 after dosing through end of surveillance period (approximately 7 months) |
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| 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. | 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. | Posted | Number | Percentage of Participants | Day 14 after dosing through end of surveillance period (approximately 7 months) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Fragment antigen-binding (F AB) unit/mL | Day 1, Day 29, and End of Season 1 (approximately 1 year) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Fold Change | Day 29 and End of Season 1 (approximately 1 year) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 29 and End of Season 1 (approximately 1 year) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 1 (post-dose) and Day 29 of Season 1 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Fold Change | Day 29 of Season 1 |
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| 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. | 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. | Posted | Number | Percentage of Participants | Day 29 of Season 1 |
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| 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. | 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. | Posted | Day 29 and End of Season 1 (approximately 1 year) |
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| 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. | 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. | Posted | Day 29 and End of Season 1 (approximately 1 year) |
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| 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. | 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. | Posted | Day 29 and End of Season 1 (approximately 1 year) |
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| 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. | 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. | Posted | Day 29 and End of Season 1 (approximately 1 year) |
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| 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. | 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. | Posted | Day 29 and End of Season 1 (approximately 1 year) |
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| 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. | 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. | Posted | Day 29 and End of Season 1 (approximately 1 year) |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 (post-dose) through Day 7 |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 (post-dose) through Day 29 |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 (post-dose) through end of Season 1 (approximately 1 year) |
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Day 1 (post-dose) through end of Season 1 (approximately 1 year)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo + IIV | Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm. | 5 | 948 | 57 | 948 | 52 | 948 |
| EG001 | MEDI7510+IIV | Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm. | 3 | 946 | 64 | 946 | 48 | 946 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemorrhagic diathesis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bradyarrhythmia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pancreatitis relapsing | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Infected lymphocele | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Non-hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Prostate cancer stage i | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of head and neck | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 19.0 | Systematic Assessment |
| |
| Device failure | Product Issues | MedDRA 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Drug dependence | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Aortic occlusion | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
The study was terminated due to failure to meet the primary efficacy endpoint.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Falloon, MD | MedImmune, LLC | 301-398-0000 | clinicaltrialenquiries@medimmune.com |
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| OG001 |
| MEDI7510 + IIV |
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm. |
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