This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
342
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
SOUSEIKAI PS Clinic
Hakata, Fukuoka, Japan
SOUSEIKAI Sumida Hopital
Sumida City, Tokyo, Japan
SOUSEIKAI Nishi-Kumamoto Hospital
Kumamoto, Japan
Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing Activity
Time frame: Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity
Time frame: Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity
Time frame: Day 29 (the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity
Time frame: Day 29 (the second dosing of the investigational product)
Geometric Mean Titer (GMT) of Anti-RSV/B Neutralizing Activity
Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/B Neutralizing Activity
Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Titer (GMT) of Anti-VAGA-9001a Immunoglobulin G (IgG)
Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-VAGA-9001a Immunoglobulin G (IgG)
Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
VAGA-9001a Specific IFN-Gamma Production Responses
Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Number of Participants Reporting Solicited Adverse Events (Local and Systemic Adverse Reactions) and Side Reactions
Time frame: Day 1 (the first dosing of the investigational product) up to Day 8, Day 29 (the second dosing of the investigational product) up to Day 36 and at time of discontinuation (whichever comes first), up to approximately 1 month
Number of Participants Reporting Non-Solicited Adverse Events and Side Reactions
Time frame: Day 1 (the first dosing of the investigational product) up to Day 57 (28 days after second dosing of the investigational product) and at time of discontinuation (whichever comes first), up to approximately 2 months
Number of Participants Reporting Serious Adverse Events and Side Reactions
Time frame: From date of informed consent up to approximately 12 months
Number of Participants Reporting Potential Immune-Mediated Disease
Time frame: Day 1 (the first dosing of the investigational product) up to the time of follow-up and discontinuation (up to approximately 12 months)