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ASP3772

Phase 1

Pneumonia, Bacterial | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Dec 21, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment630
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03803202A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal VaccinePHASE1 COMPLETED 630Jan 24, 2019Sep 28, 2020Dec 21, 202326 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]
From Day 1, Up to Day 180

An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature.

Number of Participants With TEAEs, [Stage 2, Group 2]
From Day 1, Up to Day 180

An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature. As specified in protocol, data was planned to be analyzed for PCV13 pooled comparator from each group given PCV13 to compare with each ASP3772 dose.

Number of Participants With TEAEs, [Stage 2, Group 3]
From Day 1, Up to Day 30

An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature.

Number of Participants With Clinically Significant Abnormalities in Vital Signs
During first hour post vaccination (vaccine administered at Day 1)

Vital signs parameters included blood pressure (hypotension and hypertension), pulse rate (tachycardia and bradycardia), body temperature and respiratory rate. Any change in vital sign abnormalities that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.

Number of Participants With Potentially Clinically Significant Laboratory Values
Up to Day 30

Clinical laboratory testing included hematology, clinical chemistry, or urinalysis. Any abnormal laboratory test result (e.g., in hematology, clinical chemistry, or urinalysis) that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Laboratory tests of clinical interest included total bilirubin ≥ 2x ULN and Alkaline phosphatase \> 1.5 × upper limit of normal. Study Investigator's interest was to assess only potentially clinically significant values.

Number of Participants With Potentially Clinically Significant Physical Examination Values
Up to Day 30

A physical examination consists of an examination of general appearance, eyes, nose throat, neck (including thyroid), lymph nodes, chest, lungs, cardiovascular, abdomen, skin, extremities, musculoskeletal and neurological system including mental status. Any abnormal test result that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Study Investigator's interest was to assess only potentially clinically significant values.

Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2]
Day - 28 to Day -1 (28 days prior to study vaccination)

The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management. Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE. Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.

Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 2, Group 3]
Day - 28 to Day -1 (28 days prior to study vaccination)

The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management. Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE. Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.

Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1]
Up to 7 Day post Vaccination (vaccine administered at Day 1)

Local reactions include pain, tenderness, redness/erythema, swelling and induration.

Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3]
Up to 7 Day post Vaccination (vaccine administered at Day 1)

Assessed solicited local reactions were pain, tenderness, redness/erythema, swelling, induration, itching at injection site and pruritus at injection site.

Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]
Up to 7 Day post Vaccination (vaccine administered at Day 1)

Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.

Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3]
Up to 7 Day post Vaccination (vaccine administered at Day 1)

Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.

Secondary Endpoints
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
At Day 1 and Day 30
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
At Day 1 and Day 30
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
At Day 30
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Stage 1, Group 1 Adults, ASP3772 Low doseEXPERIMENTALHealthy adults aged 18 to 64 years received a low dose \[1 microgram (μg)\] of ASP3772 intramuscularly on Day 1.
Stage 1, Group 1 Adults, ASP3772 Medium doseEXPERIMENTALHealthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
Stage 1, Group 1 Adults, ASP3772 High doseEXPERIMENTALHealthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
Stage 1, Group 1, PCV13 Pooled ComparatorACTIVE_COMPARATORHealthy adults aged 18 to 64 years received a single dose of PCV13 0.5 milliliter (mL) intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
Stage 2, Group 2 Older Adults, ASP3772 Low doseEXPERIMENTALHealthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
Stage 2, Group 2 Older Adults, ASP3772 Medium doseEXPERIMENTALHealthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
Stage 2, Group 2 Older Adults, ASP3772 High doseEXPERIMENTALHealthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
Stage 2, Group 2, PCV13 Pooled ComparatorACTIVE_COMPARATOROlder adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
Stage 2, Group 3, PPSV23 ComparatorACTIVE_COMPARATOROlder adults aged 65 to 85 years who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.
Interventions
NameTypeDescription
ASP3772BIOLOGICALParticipants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly
PCV13BIOLOGICALParticipants received a single dose of PCV13 intramuscularly.
PPSV23BIOLOGICALParticipants received a single dose of PPSV23 intramuscularly.
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites26

Inclusion Criteria: * Stage 1: Subject is healthy male or female between 18 and 64 year of age inclusive, at screening. * Stage 2: Subject is a male or female between 65 and 85 years of age, inclusive, at screening who is healthy or has chronic controlled, stable disease with no change in disease s...

Countries:United States
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