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| ID | Type | Description | Link |
|---|---|---|---|
| BB-IND 15947 | Other Identifier | US FDA |
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The purpose of this study is to determine if the administration of single ascending intramuscular doses of the RSV sF antigen or MEDI7510 will be safe and well tolerated in adults 60 years or older who are healthy or who have stable, chronic underlying medical conditions.
A phase 1a, first time in human, double-blind, randomized, placebo-controlled, cohort escalation study evaluating the safety and tolerability of a single ascending intramuscular dose of RSV sF or MEDI7510 or placebo.
Approximately 146 participants will be enrolled at 3 US study centers and randomized in a 5:1 ratio by cohort as described below:
Cohort 1: RSV sF 20 microgram (mcg) (n=20) or placebo (n=4) Cohort 1a: MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or placebo (n=4) Cohort 2: RSV sF 50 mcg (n=20) or placebo (n=4) Cohort 2a: MEDI7510 (50 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or placebo (n=4) Cohort 3: 80 mcg RSV sF (n=20) or placebo (n=4) Cohort 3a: MEDI7510 (80 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or placebo (n=4)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Sterile saline for human use from commercial source, liquid |
|
| RSV sF 20 mcg | Experimental | Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1. |
|
| MEDI7510 (20 mcg RSV sF) | Experimental | Participants will receive single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
|
| RSV sF 50 mcg | Experimental | Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
|
| MEDI7510 (50 mcg RSV sF) | Experimental | Participants will receive single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA + 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 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 greater than or equal to (>=) 100.4 degrees F by any route from Day 1 to Day 7. | Day 1 to Day 7 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A 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 product and Day 361 that were absent before treatment or that worsened relative to pretreatment state. | From Day 1 to Day 28 |
| 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 adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A 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 product and Day 361 that were absent before treatment or that worsened relative to pretreatment state. An AESI was one of scientific and medical interest specific to understanding of study product 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 investigational product and was assessed by investigator as medically significant. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2 | Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361 |
| Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Sheldon, MD | Miami Research Associates | Principal Investigator |
| Craig Curtis, MD | Compass Research | Principal Investigator |
| Steven Bart, MD | Accelovance | Principal Investigator |
| Judith Falloon, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associates | Miami | Florida | 33143 | United States | ||
| Compass Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27102821 | Result | Falloon J, Ji F, Curtis C, Bart S, Sheldon E, Krieger D, Dubovsky F, Lambert S, Takas T, Villafana T, Esser MT. A phase 1a, first-in-human, randomized study of a respiratory syncytial virus F protein vaccine with and without a toll-like receptor-4 agonist and stable emulsion adjuvant. Vaccine. 2016 May 27;34(25):2847-54. doi: 10.1016/j.vaccine.2016.04.002. Epub 2016 Apr 19. |
| Label | URL |
|---|---|
| CD-VA-MEDI7510-1134 Redacted Protocol | View source |
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A total of 146 participants were enrolled in the study. Of the 146 randomized participants, 2 participants did not receive investigational product. 144 participants were included in the As-treated Population.
A total of 246 subjects were screened. Of these, 146 subjects were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1. |
| FG001 | RSV sF 20 Microgram (mcg) | Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RSV sF 80 mcg |
| Experimental |
Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
|
| MEDI7510 (80 mcg RSV sF) | Experimental | Participants will receive a single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA + 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
|
| RSV sF 20 mcg | Biological | Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1. |
|
| MEDI7510 (20 mcg RSV sF) | Biological | Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1. |
|
| RSV sF 50 mcg | Biological | Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
|
| MEDI7510 (50 mcg RSV sF) | Biological | Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1. |
|
| RSV sF 80 mcg | Biological | Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
|
| MEDI7510 (80 mcg RSV sF) | Biological | Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1. |
|
| From Day 1 to Day 361 |
RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2. |
| Day 29, 61, 91, 181, 271 and 361 |
| Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Seroresponse defined as a greater than or equal to (>=) 4-fold rise from baseline. | Day 29 |
| Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. | Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361 |
| Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. | Day 29, 61, 91, 181, 271 and 361 |
| Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | Seroresponse defined as a greater than or equal to (>=) 4-fold rise from baseline. | Day 29 |
| Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. | Baseline (Day 1), Day 8 and 29 |
| Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. | Day 8 and 29 |
| Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8 | Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline | Day 8 |
| Orlando |
| Florida |
| 32806 |
| United States |
| Accelovance, Inc | Rockville | Maryland | 20850 | United States |
| FG002 | MEDI7510 20 Microgram (mcg) | Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| FG003 | RSV sF 50 Microgram (mcg) | Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| FG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| FG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| FG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
As-treated Population (ATP): Participants who received any study investigational product were included in the ATP population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1. |
| BG001 | RSV sF 20 Microgram (mcg) | Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1. |
| BG002 | MEDI7510 20 Microgram (mcg) | Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| BG003 | RSV sF 50 Microgram (mcg) | Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| BG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| BG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| BG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
|
| 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 | Number of Participants With 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 greater than or equal to (>=) 100.4 degrees F by any route from Day 1 to Day 7. | As-treated Population (ATP) included participants who received any study investigational product. | Posted | Number | participants | Day 1 to Day 7 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A 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 product and Day 361 that were absent before treatment or that worsened relative to pretreatment state. | As-treated Population (ATP) included participants who received any study investigational product. | Posted | Number | participants | From Day 1 to Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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 adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A 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 product and Day 361 that were absent before treatment or that worsened relative to pretreatment state. An AESI was one of scientific and medical interest specific to understanding of study product 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 investigational product and was assessed by investigator as medically significant. | As-treated Population (ATP) included participants who received any study investigational product. | Posted | Number | participants | From Day 1 to Day 361 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2 | Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, "n" is number of participants analysed for this outcome measure at give time points. | Posted | Geometric Mean | 95% Confidence Interval | titer | Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2. | Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, "n" is number of participants analysed for this outcome measure at give time points. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Day 29, 61, 91, 181, 271 and 361 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Seroresponse defined as a greater than or equal to (>=) 4-fold rise from baseline. | Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. | Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, "n" is number of participants analysed for this outcome measure at give time points. | Posted | Geometric Mean | 95% Confidence Interval | titer | Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. | Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, "n" is number of participants analysed for this outcome measure at give time points. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Day 29, 61, 91, 181, 271 and 361 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | Seroresponse defined as a greater than or equal to (>=) 4-fold rise from baseline. | Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. | Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, "N" and 'n' is number of participants analysed for this outcome measure and at given time points, respectively. | Posted | Geometric Mean | 95% Confidence Interval | spot forming counts per 10^6 PBMCs | Baseline (Day 1), Day 8 and 29 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. | Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, "N" and 'n' is number of participants analysed for this outcome measure and at given time points, respectively. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Day 8 and 29 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8 | Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline | Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 8 |
|
AEs were collected from informed consent through Day 28 post dose; SAEs from informed consent through Days 28 and 361; treatment emergent adverse events of special interest and new onset chronic diseases through the Day 361 visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1. | 2 | 24 | 5 | 24 | ||
| EG001 | RSV sF 20 Microgram (mcg) | Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1. | 0 | 20 | 3 | 20 | ||
| EG002 | MEDI7510 20 Microgram (mcg) | Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1. | 0 | 20 | 5 | 20 | ||
| EG003 | RSV sF 50 Microgram (mcg) | Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. | 5 | 20 | 8 | 20 | ||
| EG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. | 1 | 20 | 2 | 20 | ||
| EG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. | 3 | 20 | 4 | 20 | ||
| EG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. | 0 | 20 | 5 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing 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 | 301-398-5000 | falloonj@medimmune.com |
| Male |
|
Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
| OG003 | RSV sF 50 Microgram (mcg) | Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| OG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| OG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| OG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
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Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1. |
| OG002 | MEDI7510 20 Microgram (mcg) | Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| OG003 | RSV sF 50 Microgram (mcg) | Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| OG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| OG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| OG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
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| OG003 | RSV sF 50 Microgram (mcg) | Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| OG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| OG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| OG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
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| OG003 | RSV sF 50 Microgram (mcg) | Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| OG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| OG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| OG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
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| RSV sF 50 Microgram (mcg) |
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| OG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| OG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| OG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
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| OG003 | RSV sF 50 Microgram (mcg) | Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| OG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| OG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| OG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
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|
| OG003 | RSV sF 50 Microgram (mcg) | Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| OG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| OG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| OG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
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|
| RSV sF 50 Microgram (mcg) |
Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| OG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| OG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| OG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
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|
| OG003 | RSV sF 50 Microgram (mcg) | Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| OG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| OG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| OG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
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| OG003 | RSV sF 50 Microgram (mcg) | Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| OG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| OG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| OG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
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Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| OG004 | MEDI7510 50 Microgram (mcg) | Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| OG005 | RSV sF 80 Microgram (mcg) | Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| OG006 | MEDI7510 80 Microgram (mcg) | Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
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