JP81001
Fukuoka, Japan
NCT Number: NCT04265911
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.
Looking for future studies?
Notify Me20 year–85 year
All sexes
Interventional
Phase 1
Fukuoka, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous injection
Intramuscular injection
Subcutaneous injection
Other names: Pneumovax NP
Intramuscular injection
Other names: Pneumovax NP
Time frame: Up to Day 30
An adverse event (AE) is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. TEAE is defined as an AE occurring after study immunization to the last visit (up to 30 days post-vaccination if the study is discontinued for an individual subject). An IP-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator or subinvestigator.
Time frame: Up to Day 30
Percentage of participants with potentially clinically significant vital sign values.
Time frame: Up to Day 7
Local reactions include pain, tenderness, erythema/redness, swelling, and induration. The reaction will be graded with 4-range grade: 1 (mild) to 4 (potentially life-threatening).
Time frame: Up to Day 7
Systemic reactions include nausea, vomiting, diarrhea, headache, fever, fatigue and myalgia and arthralgia. Vital signs up to 7 days postvaccination are collected as systemic reactions. The reaction will be graded with 4-range grade: 1 (mild) to 4 (potentially life-threatening).
Time frame: Up to Day 30
Percentage of participants with potentially clinically significant laboratory values.
Time frame: Up to Day 30
Percentage of participants with potentially clinically significant ECG values.
Time frame: Up to Day 30
Percentage of participants with potentially clinically significant physical exam values.
Time frame: On Day 30
OPA measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Time frame: On Day 30
OPA measure will be used to characterize the immunological response on Day 30 after administration of PPSV23
Time frame: On Day 30
OPA measure will be used to characterize the immunological response on Day 30 after administration of ASP3772 and PPSV23
Time frame: On Day 30
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Time frame: On Day 30
PS IgG measure measure will be used to characterize the immunological response on Day 30 after administration of PPSV23
Time frame: On Day 30
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772 and PPSV23.
Time frame: On Day 30
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Time frame: On Day 30
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of PPSV23
Time frame: On Day 30
OPA titer will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Time frame: On Day 30
OPA titer will be used to characterize the immunological response on Day 30 after administration of PPSV23
Time frame: On Day 30
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Time frame: On Day 30
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of PPSV23
Time frame: On Day 30
OPA titer will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Time frame: On Day 30
OPA titer will be used to characterize the immunological response on Day 30 after administration of PPSV23
Affinivax, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05447078
Healthy Volunteers, Infections
Jackson, Mississippi, United States
View Trial DetailsNCT07513532
Healthy Volunteers
Seattle, Washington, United States
View Trial DetailsNCT07090655
Healthy Volunteers
Brisbane, Australia
View Trial DetailsNCT01915212
Communicable Diseases, DNA Virus Infections
Bethesda, Maryland, United States
View Trial Details