A Ph2, randomized, double-blind, dose finding study to describe the immunogenicity, safety and tolerability of VN-0200 in Japanese adults aged 60-80 years
- Conditions
- Prevention of respiratory syncytial viral infection
- Registration Number
- JPRN-jRCT2071220051
- Lead Sponsor
- Inoguchi Akihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 340
1) Healthy Japanese subjects aged 60 to 80 years of age at the time of informed consent.
2) Subjects who complied with the compliance instructions in the study, underwent physical examination and examinations specified in the protocol, and were able to report symptoms, etc.
-Serious cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disorders.
-Serious acute illness.
-Has been diagnosed with congenital or acquired immunodeficiency.
-Previous vaccination with an RSV vaccine (including the investigational drugs)
-Having a history of anaphylaxis or severe allergies due to medicines, or vaccination, etc.
-Administration of gamma globulins, systemic immunosuppressants (including drugs for the treatment of autoimmune diseases), hematopoietics (excluding iron and vitamins), and corticosteroids (excluding topical preparations, inhalants, and small-dose short-term oral administration*) or planned administration of them in the period starting 28 days prior to informed consent and ending 28 days after the second vaccination. * <14 days, <=20 mg/day on a prednisolone basis.
-Planned or actual administration of other vaccine in the period starting 14 days prior to informed consent and ending 14 days after the second vaccination., etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method