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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210069

Registered date:07/05/2021

A Phase 1 study to assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injection in Japanese healthy adults and elderly subjects

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPrevention of respiratory syncytial virus
Date of first enrollment11/06/2021
Target sample size48
Countries of recruitment
Study typeInterventional
Intervention(s)VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) or placebo 0.5 mL is administered twice on Day 1 and Day 29.

Outcome(s)

Primary OutcomeSafety:Adverse events, specific adverse events, Potential Immune-Mediated Disease, laboratory data, body weight, vital signs and 12-lead ECGs,
Secondary OutcomeGeometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing activity, Geometric Mean Titer (GMT) of anti-VAGA-9001a IgG, GMT of anti-RSV G IgG, VAGA-9001a-specific IFN-gamma production

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include criteria1. Japanese healthy subjects. 2. Age >=20 and <=50 years upon providing informed consent at step1 or Age >=65 and <=80 years upon providing informed consent at step2. 3. Body mass index (BMI) >=18.0 and <30.0 kg/m2 at screening.
Exclude criteria1. Subjects with a history of anaphylaxis or severe allergies due to food, medicine, insect bites, cosmetics, or vaccination 2. Having alcohol or drug dependence etc.

Related Information

Contact

Public contact
Name Contact for Clinical Trial Information
Address 1-2-58, Hiromachi, Shinagawa-ku, Tokyo Tokyo Japan 140-8710
Telephone +81-3-6225-1111
E-mail dsclinicaltrial@daiichisankyo.co.jp
Affiliation DAIICHI SANKYO Co.,Ltd.
Scientific contact
Name Akihiro Inoguchi
Address 1-2-58, Hiromachi, Shinagawa-ku, Tokyo Tokyo Japan 140-8710
Telephone +81-3-6225-1111
E-mail dsclinicaltrial@daiichisankyo.co.jp
Affiliation DAIICHI SANKYO Co.,Ltd.