Respiratory Syncytial Virus (RSV)
Conditions
Keywords
Respiratory Syncytial Virus (RSV), MEDI7510
Brief summary
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.
Detailed description
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)
Interventions
BIOLOGICALPlacebo
Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1.
BIOLOGICALRSV sF 20 mcg
Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
BIOLOGICALMEDI7510 (20 mcg RSV sF)
Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1.
BIOLOGICALRSV sF 50 mcg
Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
BIOLOGICALMEDI7510 (50 mcg RSV sF)
Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1.
BIOLOGICALRSV sF 80 mcg
Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
BIOLOGICALMEDI7510 (80 mcg RSV sF)
Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Age greater than or equal to 60 years * Written informed consent and any locally required authorization obtained prior to any protocol related procedures * Ambulatory or ambulatory with assistance (not institutionalized, bedridden, or homebound * Weight at or above 110 Pounds (lbs) * Hemoglobin within normal range for age and gender
Exclusion criteria
* History of allergy to any component of the vaccine * Pregnancy or potential to become pregnant during the study. Females who have had a menstrual period within the 12 months prior to study enrollment or are undergoing any fertility treatment or who plan to undergo fertility treatments during the study period are excluded * Any unstable chronic medical condition, including one that has resulted in change in therapy (medication or other) in the 30 days prior to randomization or hospitalization in the previous year or might be predicted to result in hospitalization in the year after enrollment. Participant with severe, untreated or uncontrolled underlying medical disease that might either compromise participant safety or affect the ability to assess safety of the investigational product are excluded * Clinically significant abnormalities in Screening laboratory assessments or Screening electrocardiogram (ECG) * History of hepatitis B or hepatitis C infection * Cognitive disorder such that informed consent cannot be obtained directly from the participant * Previous vaccination against respiratory syncytial virus (RSV) * History of allergy to eggs in adulthood * History of or current autoimmune disorder * Immunosuppression caused by disease, including human immunodeficiency virus (HIV), or medications. Any oral prednisone dosing within 30 days of enrollment or planned dosing within the 360-day follow-up period would disqualify. * History of splenectomy or of condition affecting splenic function * History of cancer within preceding 5 years other than treated non-melanoma skin cancer * Body Mass Index 40 or higher * Significant infection or other acute illness, including fever over 100 fahrenheit (F) on the day prior to or day of randomization * Receipt of any nonstudy vaccine within 30 days prior to study dosing or expected receipt of nonstudy vaccine within 30 days after study dosing * Receipt of any investigational product in the 90 days prior to randomization or expected receipt of investigational product during the period of study follow-up * Receipt of immunoglobulins or blood products within 4 months of study dosing (120 days) or expected receipt of investigational product during the period of study follow-up * History of thrombocytopenia or bleeding disorder or use of anticoagulants. Participants receiving drugs with anti-platelet activity such as nonsteroidal antiinflammatory drugs, clopidogrel or aspirin are not excluded * Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 72 hours after receipt of investigational product (IP) \[a daily dose of 163 milligram (mg) or higher is not considered a contraindication to enrollment\] * Participants who have significant scarring, tattoos, abrasions, cuts, or infections over the deltoid region of both arms that, in the principle investigator's (PI) opinion, could interfere with evaluation of injection site local reactions * Concurrent enrollment in another clinical study that involves any invasive clinical procedure, including phlebotomy * History of alcohol or drug abuse or psychiatric disorder that in the PI's opinion would affect the participants safety or compliance with study * Employees of individuals directly involved with the conduct of the study, individuals who themselves are involved with the conduct of the study, or immediate family members of such individuals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Symptoms | Day 1 to Day 7 | 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. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From Day 1 to Day 28 | 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. |
| 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) | From Day 1 to Day 361 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361 | Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. |
| 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 | Day 29, 61, 91, 181, 271 and 361 | Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. |
| Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | Day 29 | Seroresponse defined as a greater than or equal to (\>=) 4-fold rise from baseline. |
| Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361 | RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2 |
| Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 and 29 | The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. |
| Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8 | Day 8 | Seroresponse defined as a greater than or equal to (\>=) 3-fold rise from baseline |
| Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Baseline (Day 1), Day 8 and 29 | The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. |
| Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29, 61, 91, 181, 271 and 361 | RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2. |
| Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 | Seroresponse defined as a greater than or equal to (\>=) 4-fold rise from baseline. |
Countries
United States
Participant flow
Recruitment details
A total of 246 subjects were screened. Of these, 146 subjects were enrolled.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1. | 24 |
| RSV sF 20 Microgram (mcg) Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1. | 20 |
| 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. | 20 |
| RSV sF 50 Microgram (mcg) Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1. | 20 |
| 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. | 20 |
| RSV sF 80 Microgram (mcg) Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1. | 20 |
| 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. | 20 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Missed appointment, randomized in error | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Not enough drug to dose participant | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | RSV sF 50 Microgram (mcg) | MEDI7510 50 Microgram (mcg) | RSV sF 80 Microgram (mcg) | MEDI7510 80 Microgram (mcg) | Placebo | RSV sF 20 Microgram (mcg) | MEDI7510 20 Microgram (mcg) | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 69.3 Years STANDARD_DEVIATION 5.6 | 70.5 Years STANDARD_DEVIATION 6.1 | 70.0 Years STANDARD_DEVIATION 7 | 69.4 Years STANDARD_DEVIATION 7 | 68.6 Years STANDARD_DEVIATION 7.6 | 66.5 Years STANDARD_DEVIATION 6 | 66.6 Years STANDARD_DEVIATION 4.1 | 68.7 Years STANDARD_DEVIATION 6.4 |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 8 Participants | 11 Participants | 11 Participants | 9 Participants | 9 Participants | 68 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 12 Participants | 9 Participants | 13 Participants | 11 Participants | 11 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 24 | 3 / 20 | 5 / 20 | 8 / 20 | 2 / 20 | 4 / 20 | 5 / 20 |
| serious Total, serious adverse events | 2 / 24 | 0 / 20 | 0 / 20 | 5 / 20 | 1 / 20 | 3 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Day 1 to Day 7
Population: As-treated Population (ATP) included participants who received any study investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Solicited Symptoms | 6 participants |
| RSV sF 20 Microgram (mcg) | Number of Participants With Solicited Symptoms | 4 participants |
| MEDI7510 20 Microgram (mcg) | Number of Participants With Solicited Symptoms | 15 participants |
| RSV sF 50 Microgram (mcg) | Number of Participants With Solicited Symptoms | 7 participants |
| MEDI7510 50 Microgram (mcg) | Number of Participants With Solicited Symptoms | 14 participants |
| RSV sF 80 Microgram (mcg) | Number of Participants With Solicited Symptoms | 9 participants |
| MEDI7510 80 Microgram (mcg) | Number of Participants With Solicited Symptoms | 17 participants |
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.
Time frame: From Day 1 to Day 361
Population: As-treated Population (ATP) included participants who received any study investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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) | NOCDs | 2 participants |
| Placebo | 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) | TESAEs | 2 participants |
| Placebo | 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) | TEAESIs | 0 participants |
| RSV sF 20 Microgram (mcg) | 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) | TESAEs | 0 participants |
| RSV sF 20 Microgram (mcg) | 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) | TEAESIs | 0 participants |
| RSV sF 20 Microgram (mcg) | 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) | NOCDs | 0 participants |
| MEDI7510 20 Microgram (mcg) | 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) | NOCDs | 0 participants |
| MEDI7510 20 Microgram (mcg) | 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) | TEAESIs | 0 participants |
| MEDI7510 20 Microgram (mcg) | 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) | TESAEs | 0 participants |
| RSV sF 50 Microgram (mcg) | 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) | TEAESIs | 0 participants |
| RSV sF 50 Microgram (mcg) | 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) | NOCDs | 4 participants |
| RSV sF 50 Microgram (mcg) | 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) | TESAEs | 5 participants |
| MEDI7510 50 Microgram (mcg) | 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) | TESAEs | 1 participants |
| MEDI7510 50 Microgram (mcg) | 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) | TEAESIs | 0 participants |
| MEDI7510 50 Microgram (mcg) | 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) | NOCDs | 1 participants |
| RSV sF 80 Microgram (mcg) | 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) | TEAESIs | 0 participants |
| RSV sF 80 Microgram (mcg) | 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) | TESAEs | 3 participants |
| RSV sF 80 Microgram (mcg) | 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) | NOCDs | 4 participants |
| MEDI7510 80 Microgram (mcg) | 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) | TESAEs | 0 participants |
| MEDI7510 80 Microgram (mcg) | 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) | NOCDs | 2 participants |
| MEDI7510 80 Microgram (mcg) | 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) | TEAESIs | 0 participants |
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.
Time frame: From Day 1 to Day 28
Population: As-treated Population (ATP) included participants who received any study investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 5 participants |
| RSV sF 20 Microgram (mcg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| RSV sF 20 Microgram (mcg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 3 participants |
| MEDI7510 20 Microgram (mcg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 5 participants |
| MEDI7510 20 Microgram (mcg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| RSV sF 50 Microgram (mcg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 8 participants |
| RSV sF 50 Microgram (mcg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 2 participants |
| MEDI7510 50 Microgram (mcg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI7510 50 Microgram (mcg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 2 participants |
| RSV sF 80 Microgram (mcg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 4 participants |
| RSV sF 80 Microgram (mcg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI7510 80 Microgram (mcg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 5 participants |
| MEDI7510 80 Microgram (mcg) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
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
Time frame: Day 8
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8 | 0 percentage of participants |
| RSV sF 20 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8 | 12.5 percentage of participants |
| MEDI7510 20 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8 | 18.8 percentage of participants |
| RSV sF 50 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8 | 25.0 percentage of participants |
| MEDI7510 50 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8 | 35.3 percentage of participants |
| RSV sF 80 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8 | 46.7 percentage of participants |
| MEDI7510 80 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8 | 73.7 percentage of participants |
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.
Time frame: Day 29
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | 0 percentage of participants |
| RSV sF 20 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | 65.0 percentage of participants |
| MEDI7510 20 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | 90.0 percentage of participants |
| RSV sF 50 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | 80.0 percentage of participants |
| MEDI7510 50 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | 90.0 percentage of participants |
| RSV sF 80 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | 84.2 percentage of participants |
| MEDI7510 80 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | 100.0 percentage of participants |
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.
Time frame: Day 29
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | 0 percentage of participants |
| RSV sF 20 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | 10.0 percentage of participants |
| MEDI7510 20 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | 5.0 percentage of participants |
| RSV sF 50 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | 5.0 percentage of participants |
| MEDI7510 50 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | 10.5 percentage of participants |
| RSV sF 80 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | 26.3 percentage of participants |
| MEDI7510 80 Microgram (mcg) | Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | 25.0 percentage of participants |
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.
Time frame: Baseline (Day 1), Day 8 and 29
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 40.91 spot forming counts per 10^6 PBMCs |
| Placebo | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 41.01 spot forming counts per 10^6 PBMCs |
| Placebo | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Baseline (n= 22, 16, 18, 19, 18, 20, 20) | 47.17 spot forming counts per 10^6 PBMCs |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 62.63 spot forming counts per 10^6 PBMCs |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Baseline (n= 22, 16, 18, 19, 18, 20, 20) | 41.59 spot forming counts per 10^6 PBMCs |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 39.93 spot forming counts per 10^6 PBMCs |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 60.30 spot forming counts per 10^6 PBMCs |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Baseline (n= 22, 16, 18, 19, 18, 20, 20) | 35.95 spot forming counts per 10^6 PBMCs |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 88.72 spot forming counts per 10^6 PBMCs |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 80.25 spot forming counts per 10^6 PBMCs |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Baseline (n= 22, 16, 18, 19, 18, 20, 20) | 39.81 spot forming counts per 10^6 PBMCs |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 69.36 spot forming counts per 10^6 PBMCs |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 115.88 spot forming counts per 10^6 PBMCs |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Baseline (n= 22, 16, 18, 19, 18, 20, 20) | 48.44 spot forming counts per 10^6 PBMCs |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 91.15 spot forming counts per 10^6 PBMCs |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Baseline (n= 22, 16, 18, 19, 18, 20, 20) | 37.78 spot forming counts per 10^6 PBMCs |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 77.13 spot forming counts per 10^6 PBMCs |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 88.59 spot forming counts per 10^6 PBMCs |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 54.74 spot forming counts per 10^6 PBMCs |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 310.22 spot forming counts per 10^6 PBMCs |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Baseline (n= 22, 16, 18, 19, 18, 20, 20) | 38.43 spot forming counts per 10^6 PBMCs |
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.
Time frame: Day 29, 61, 91, 181, 271 and 361
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 1.05 fold rise |
| Placebo | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 1.02 fold rise |
| Placebo | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 1.11 fold rise |
| Placebo | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 1.04 fold rise |
| Placebo | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 1.11 fold rise |
| Placebo | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 1.08 fold rise |
| RSV sF 20 Microgram (mcg) | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 4.84 fold rise |
| RSV sF 20 Microgram (mcg) | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 3.77 fold rise |
| RSV sF 20 Microgram (mcg) | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 7.78 fold rise |
| RSV sF 20 Microgram (mcg) | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 3.56 fold rise |
| RSV sF 20 Microgram (mcg) | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 6.74 fold rise |
| RSV sF 20 Microgram (mcg) | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 8.06 fold rise |
| MEDI7510 20 Microgram (mcg) | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 5.63 fold rise |
| MEDI7510 20 Microgram (mcg) | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 3.63 fold rise |
| MEDI7510 20 Microgram (mcg) | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 10.15 fold rise |
| MEDI7510 20 Microgram (mcg) | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 3.03 fold rise |
| MEDI7510 20 Microgram (mcg) | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 2.87 fold rise |
| MEDI7510 20 Microgram (mcg) | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 7.00 fold rise |
| RSV sF 50 Microgram (mcg) | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 4.46 fold rise |
| RSV sF 50 Microgram (mcg) | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 8.93 fold rise |
| RSV sF 50 Microgram (mcg) | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 7.87 fold rise |
| RSV sF 50 Microgram (mcg) | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 5.42 fold rise |
| RSV sF 50 Microgram (mcg) | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 4.14 fold rise |
| RSV sF 50 Microgram (mcg) | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 12.07 fold rise |
| MEDI7510 50 Microgram (mcg) | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 7.54 fold rise |
| MEDI7510 50 Microgram (mcg) | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 9.37 fold rise |
| MEDI7510 50 Microgram (mcg) | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 3.84 fold rise |
| MEDI7510 50 Microgram (mcg) | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 3.19 fold rise |
| MEDI7510 50 Microgram (mcg) | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 12.39 fold rise |
| MEDI7510 50 Microgram (mcg) | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 4.88 fold rise |
| RSV sF 80 Microgram (mcg) | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 5.43 fold rise |
| RSV sF 80 Microgram (mcg) | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 7.84 fold rise |
| RSV sF 80 Microgram (mcg) | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 4.14 fold rise |
| RSV sF 80 Microgram (mcg) | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 9.55 fold rise |
| RSV sF 80 Microgram (mcg) | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 3.86 fold rise |
| RSV sF 80 Microgram (mcg) | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 13.21 fold rise |
| MEDI7510 80 Microgram (mcg) | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 5.27 fold rise |
| MEDI7510 80 Microgram (mcg) | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 15.39 fold rise |
| MEDI7510 80 Microgram (mcg) | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 21.02 fold rise |
| MEDI7510 80 Microgram (mcg) | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 5.12 fold rise |
| MEDI7510 80 Microgram (mcg) | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 12.58 fold rise |
| MEDI7510 80 Microgram (mcg) | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 8.19 fold rise |
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.
Time frame: Day 29, 61, 91, 181, 271 and 361
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 0.82 fold rise |
| Placebo | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 1.18 fold rise |
| Placebo | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 1.16 fold rise |
| Placebo | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 7, 0, 0, 0, 0, 17, 19) | 0.73 fold rise |
| Placebo | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 0.87 fold rise |
| Placebo | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 0.97 fold rise |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 1.13 fold rise |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 1.71 fold rise |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 1.75 fold rise |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 1.66 fold rise |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 7, 0, 0, 0, 0, 17, 19) | NA fold rise |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 1.97 fold rise |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 1.74 fold rise |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 1.15 fold rise |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 1.60 fold rise |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 7, 0, 0, 0, 0, 17, 19) | NA fold rise |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 2.20 fold rise |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 2.08 fold rise |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 1.96 fold rise |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 2.19 fold rise |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 2.14 fold rise |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 2.01 fold rise |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 7, 0, 0, 0, 0, 17, 19) | NA fold rise |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 1.30 fold rise |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 7, 0, 0, 0, 0, 17, 19) | NA fold rise |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 2.47 fold rise |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 2.53 fold rise |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 1.61 fold rise |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 1.10 fold rise |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 2.29 fold rise |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 7, 0, 0, 0, 0, 17, 19) | 1.32 fold rise |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 1.50 fold rise |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 1.92 fold rise |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 1.38 fold rise |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 1.72 fold rise |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 2.51 fold rise |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 2.32 fold rise |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 7, 0, 0, 0, 0, 17, 19) | 1.14 fold rise |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 2.44 fold rise |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 1.43 fold rise |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 1.32 fold rise |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 3.28 fold rise |
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.
Time frame: Day 8 and 29
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 0.90 fold rise |
| Placebo | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 0.88 fold rise |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 1.57 fold rise |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 0.91 fold rise |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 2.18 fold rise |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 1.54 fold rise |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 2.01 fold rise |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 1.80 fold rise |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 2.21 fold rise |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 1.99 fold rise |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 2.45 fold rise |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 2.10 fold rise |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 8 (n= 20, 20, 18, 17, 18, 15, 19) | 8.01 fold rise |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT) | Day 29 (n= 23, 16, 20, 19, 20, 19, 14) | 1.36 fold rise |
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.
Time frame: Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 66.16 titer |
| Placebo | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 71.57 titer |
| Placebo | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 71.76 titer |
| Placebo | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 73.17 titer |
| Placebo | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 68.41 titer |
| Placebo | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 78.65 titer |
| Placebo | 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 | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 64.89 titer |
| RSV sF 20 Microgram (mcg) | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 305.06 titer |
| RSV sF 20 Microgram (mcg) | 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 | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 45.24 titer |
| RSV sF 20 Microgram (mcg) | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 211.75 titer |
| RSV sF 20 Microgram (mcg) | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 364.83 titer |
| RSV sF 20 Microgram (mcg) | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 159.37 titer |
| RSV sF 20 Microgram (mcg) | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 351.98 titer |
| RSV sF 20 Microgram (mcg) | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 170.78 titer |
| MEDI7510 20 Microgram (mcg) | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 658.97 titer |
| MEDI7510 20 Microgram (mcg) | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 235.81 titer |
| MEDI7510 20 Microgram (mcg) | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 186.26 titer |
| MEDI7510 20 Microgram (mcg) | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 196.53 titer |
| MEDI7510 20 Microgram (mcg) | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 454.40 titer |
| MEDI7510 20 Microgram (mcg) | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 365.38 titer |
| MEDI7510 20 Microgram (mcg) | 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 | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 64.94 titer |
| RSV sF 50 Microgram (mcg) | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 998.28 titer |
| RSV sF 50 Microgram (mcg) | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 587.79 titer |
| RSV sF 50 Microgram (mcg) | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 738.48 titer |
| RSV sF 50 Microgram (mcg) | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 405.25 titer |
| RSV sF 50 Microgram (mcg) | 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 | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 82.73 titer |
| RSV sF 50 Microgram (mcg) | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 332.98 titer |
| RSV sF 50 Microgram (mcg) | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 309.01 titer |
| MEDI7510 50 Microgram (mcg) | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 456.76 titer |
| MEDI7510 50 Microgram (mcg) | 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 | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 93.51 titer |
| MEDI7510 50 Microgram (mcg) | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 1159.03 titer |
| MEDI7510 50 Microgram (mcg) | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 875.86 titer |
| MEDI7510 50 Microgram (mcg) | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 704.64 titer |
| MEDI7510 50 Microgram (mcg) | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 358.67 titer |
| MEDI7510 50 Microgram (mcg) | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 298.08 titer |
| RSV sF 80 Microgram (mcg) | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 463.64 titer |
| RSV sF 80 Microgram (mcg) | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 924.44 titer |
| RSV sF 80 Microgram (mcg) | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 351.12 titer |
| RSV sF 80 Microgram (mcg) | 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 | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 76.61 titer |
| RSV sF 80 Microgram (mcg) | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 376.48 titer |
| RSV sF 80 Microgram (mcg) | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 731.83 titer |
| RSV sF 80 Microgram (mcg) | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 596.80 titer |
| MEDI7510 80 Microgram (mcg) | 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 | Day 29 (n= 24, 20, 20, 20, 20, 19, 20) | 1552.03 titer |
| MEDI7510 80 Microgram (mcg) | 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 | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 604.90 titer |
| MEDI7510 80 Microgram (mcg) | 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 | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 364.40 titer |
| MEDI7510 80 Microgram (mcg) | 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 | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 1136.41 titer |
| MEDI7510 80 Microgram (mcg) | 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 | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 73.84 titer |
| MEDI7510 80 Microgram (mcg) | 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 | Day 361 (n= 18, 19, 20, 19, 20, 17, 19) | 374.98 titer |
| MEDI7510 80 Microgram (mcg) | 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 | Day 91 (n= 22, 20, 20, 19, 20, 19, 20) | 928.58 titer |
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
Time frame: Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 535.19 titer |
| Placebo | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 441.37 titer |
| Placebo | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 18, 0, 0, 0, 0, 17, 19) | 491.90 titer |
| Placebo | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 430.04 titer |
| Placebo | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 485.89 titer |
| Placebo | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 513.18 titer |
| Placebo | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 373.79 titer |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 362.67 titer |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 619.09 titer |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 600.28 titer |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 419.68 titer |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 635.83 titer |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 716.09 titer |
| RSV sF 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 18, 0, 0, 0, 0, 17, 19) | NA titer |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 764.04 titer |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 18, 0, 0, 0, 0, 17, 19) | NA titer |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 809.84 titer |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 367.73 titer |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 589.97 titer |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 641.14 titer |
| MEDI7510 20 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 421.09 titer |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 849.22 titer |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 448.36 titer |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 981.61 titer |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 959.74 titer |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 548.95 titer |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 829.32 titer |
| RSV sF 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 18, 0, 0, 0, 0, 17, 19) | NA titer |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 18, 0, 0, 0, 0, 17, 19) | NA titer |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 442.03 titer |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 1013.06 titer |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 1092.18 titer |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 1182.72 titer |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 710.41 titer |
| MEDI7510 50 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 487.07 titer |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 18, 0, 0, 0, 0, 17, 19) | 675.04 titer |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 491.31 titer |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 1116.48 titer |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 761.54 titer |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 705.14 titer |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 834.48 titer |
| RSV sF 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 945.22 titer |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 91 (n= 23, 20, 20, 19, 20, 19, 20) | 992.21 titer |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 181 (n= 23, 19, 20, 19, 20, 18, 20) | 614.39 titer |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 29 (n= 24, 20, 20, 20, 19, 19, 20) | 1405.14 titer |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 271 (n= 20, 20, 20, 19, 20, 17, 19) | 560.89 titer |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Baseline (n= 24, 20, 20, 20, 20, 20, 20) | 428.16 titer |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 361 (n= 18, 0, 0, 0, 0, 17, 19) | 483.15 titer |
| MEDI7510 80 Microgram (mcg) | Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay | Day 61 (n= 24, 20, 20, 20, 20, 20, 20) | 1046.60 titer |