Last updated: 09/24/2026 11:31:12
Single Ascending Dose Study in Japanese Healthy Male and Female Adults, and PPSV23-controlled, Randomized, Single Ascending Dose Study in Japanese Elderly Male and Female Subjects
GSK study ID
219661
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: ASP3772 Phase 1 Study: Single Ascending Dose Study in Japanese Healthy Male and Female Adults, and PPSV23-controlled, Randomized, Single Ascending Dose Study in Japanese Elderly Male and Female Subjects
Trial description: The purpose of this study is to evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly to Japanese healthy adults 20 to 49 years of age.This study will also evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly, in comparison to the active comparator 23-valent pneumococcal polysaccharide vaccine (PPSV23) in Japanese elderly subjects 65 to 85 years of age.
Primary purpose:
Not applicable
Trial design:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants with Treatment Emergent Adverse Events (TEAEs), Stage 1
Timeframe: From Day 1 to Day 30
Number of participants with TEAEs [Stage 2]
Timeframe: From Day 1 to Day 30
Vital Signs: Body Temperature [Stage 1]
Timeframe: Screening (Day-28 Pre-dose), Day 1 (60 minutes Pre-dose), Day 1 (30 minutes Post-dose), Day 1 (60 minutes Post-dose), Day 7 and Day 30
Vital Signs: Pulse Rate[Stage 1]
Timeframe: Screening (Day-28 Pre-dose), Day 1 (60 minutes Pre-dose), Day 1 (30 minutes Post-dose), Day 1 (60 minutes Post-dose), Day 7 and Day 30
Vital Signs: Blood Pressure [Stage 1]
Timeframe: Screening (Day-28 Pre-dose), Day 1 (60 minutes Pre-dose), Day 1 (30 minutes Post-dose), Day 1 (60 minutes Post-dose), Day 7 and Day 30
Vital Signs: Respiratory Rate [Stage 1]
Timeframe: At Day 1 (60 minutes Pre-dose), Day 1 (30 minutes Post-dose) and Day 1 (60 minutes Post-dose)
Vital Sign: Body Temperature [Stage 2]
Timeframe: Screening (Day-28 Pre-dose), Day 1 (60 minutes Pre-dose), Day 1 (30 minutes Post-dose), Day 1 (60 minutes Post-dose), Day 7 and Day 30
Vital Signs: Pulse Rate [Stage 2]
Timeframe: Screening (Day-28 Pre-dose), Day 1 (60 minutes Pre-dose), Day 1 (30 minutes Post-dose), Day 1 (60 minutes Post-dose), Day 7 and Day 30
Vital Signs: Blood Pressure [Stage 2]
Timeframe: Screening (Day-28 Pre-dose), Day 1 (60 minutes Pre-dose), Day 1 (30 minutes Post-dose), Day 1 (60 minutes Post-dose), Day 7 and Day 30
Vital Signs: Respiratory Rate [Stage 2]
Timeframe: At Day 1 (60 minutes Pre-dose), Day 1 (30 minutes Post-dose) and Day 1 (60 minutes Post-dose)
Number of participants with Solicited Local Reactions [Stage 1]
Timeframe: Day 1 to Day 7
Number of participants with Solicited Local Reactions [Stage 2]
Timeframe: Day 1 to Day 7
Number of participants with Solicited Systemic Reactions [Stage 1]
Timeframe: Day 1 to Day 7
Number of participants with Solicited Systemic Reactions [Stage 2]
Timeframe: Day 1 to Day 7
Number of Participants With Clinically Significant Physical Examination Values
Timeframe: Up to Day 30
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG)
Timeframe: Screening (Day-28 Pre-dose), Day 1, Day 7 and Day 30
Number of Participants With Potentially Clinically Significant Laboratory Values
Timeframe: Up to Day 30
Secondary outcomes:
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer [Stage 1]
Timeframe: On Day 1 and Day 30
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG) Concentration [Stage 1]
Timeframe: On Day 1 and Day 30
Geometric Mean Fold Rise (GMFR) for Serotype-specific IgG [Stage 1]
Timeframe: On Day 30
GMFR for Serotype-specific OPA [Stage 1]
Timeframe: On Day 30
Percentage of participants with a greater than or equal to (>=) 4-fold increase in Serotype-specific IgG Concentration relative to baseline [Stage 1]
Timeframe: On Day 30
Percentage of participants with a >= 4-fold increase in Serotype-specific OPA Antibody Titer relative to baseline [Stage 1]
Timeframe: On Day 30
GMTs for Serotype-specific OPA [Stage 2]
Timeframe: On Day 1 and Day 30
GMCs for Serotype-specific IgG [Stage 2]
Timeframe: On Day 1 and Day 30
GMFR for Serotype-specific IgG [Stage 2]
Timeframe: On Day 30
GMFR for Serotype-specific OPA [Stage 2]
Timeframe: On Day 30
Percentage of participants with a >= 4-fold increase in Serotype-specific IgG Concentration relative to baseline [Stage 2]
Timeframe: On Day 30
Percentage of participants with a >= 4-fold increase in Serotype-specific OPA Antibody Titer relative to baseline [Stage 2]
Timeframe: On day 30
GMTs for Unique Serotype-specific OPA [Stage 2]
Timeframe: On Day 1 and Day 30
GMCs for Unique Serotype-specific IgG [Stage 2]
Timeframe: On Day 1 and Day 30
GMFR for Unique Serotype-specific IgG [Stage 2]
Timeframe: On Day 30
GMFR for Unique Serotype-specific OPA [Stage 2]
Timeframe: On Day 30
Percentage of participants with a >= 4-fold increase in Unique Serotype-specific IgG Concentration relative to baseline [Stage 2]
Timeframe: On day 30
Percentage of participants with a >= 4-fold increase in Unique Serotype-specific OPA Antibody Titer relative to baseline [Stage 2]
Timeframe: On day 30
Interventions:
Biological/vaccine: ASP3772 (subcutaneous)
Biological/vaccine: ASP3772 (intramuscular)
Biological/vaccine: PPSV23 (subcutaneous)
Biological/vaccine: PPSV23 (intramuscular)
Enrollment:
0
Primary completion date:
2020-07-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Borys D, Smulders R, Haranaka M, Nakano T, Chichili GR, Ebara M, Hashimoto A, Iwahana M, Oizumi Y, Nanra J, Malley R, Sebastian S. Safety, reactogenicity, and immunogenicity of a novel 24-valent pneumococcal vaccine candidate in healthy, pneumococcal vaccine-naïve Japanese adults: A phase 1 randomized dose-escalation trial. Vaccine. 2024 Nov 28;44:126545.
PMID: 39612802
D.O.I: 10.1016/j.vaccine.2024.126545
Medical condition
Pneumonia, Bacterial
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2020 to November 2020
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
20 - 85 Years
Accepts healthy volunteers
Yes
- Group 1: Subject is a healthy male or female between 20 and 49 years of age inclusive, at informed consent.
- Exclusion Criteria
- Subject has had previous vaccination with any licensed or investigational pneumococcal vaccine at any time.
- Subject has a history of microbiologically-proven invasive disease caused by Streptococcus pneumoniae.
Inclusion and exclusion criteria
Inclusion criteria:
- Group 1: Subject is a healthy male or female between 20 and 49 years of age inclusive, at informed consent. Exclusion Criteria -Group 2: Subject is a male or female between 65 and 85 years of age inclusive, at informed consent who is healthy or has chronic controlled, stable disease with no change in disease severity, medical therapy and no hospitalization history in last 12 weeks from informed consent as determined by medical history, physical examination, and laboratory data. -Female subject of non-childbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception. -Subject agrees not to participate in another interventional study while participating in the present study. -Subject has a body mass index (BMI) range of 17.6 to 26.4 kg/m^2 inclusive in Group 1 and 15.4 to 28.6 kg/m^2 inclusive in Group 2, and body weight at least 50 kg for male and 40 kg for female at screening.
Exclusion criteria:
- Subject has had previous vaccination with any licensed or investigational pneumococcal vaccine at any time. -Subject has a history of microbiologically-proven invasive disease caused by Streptococcus pneumoniae. -Subject has an immune disorder(s) (including autoimmune disease), clinical conditions requiring immunosuppressive drugs and/or a close relative who has congenital immunodeficiency. -Group 1: Subject has any illness that requires medication or treatment. -Group 2: Subject has any evidence of unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease, e.g., uncontrolled hypertension, uncontrolled diabetes, heart failure, uncontrolled chronic obstructive pulmonary disease, end-stage renal disease, malignancy which is active and requires treatment. -Subject has any clinically significant history of allergic conditions including drug allergies, asthma or anaphylactic reactions, but excluding untreated asymptomatic seasonal allergies just before study vaccine administration. -Subject has a positive serology test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies (anti-HCV) or antigens/antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening. -Subject has/had febrile illness or symptomatic of viral, bacterial (including upper respiratory infection) or fungal (excluding skin infection) infection within 7 days prior to day 1.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2020-07-11
Actual study completion date
2020-07-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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