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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210069

Enrollment

Registered

2021-05-07

Start date

2021-06-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of respiratory syncytial virus

Interventions

VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) or placebo 0.5 mL is administered twice on Day 1 and Day 29.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese healthy subjects. 2. Age >=20 and =65 and =18.0 and <30.0 kg/m2 at screening.

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
Safety:Adverse events, specific adverse events, Potential Immune-Mediated Disease, laboratory data, body weight, vital signs and 12-lead ECGs,	—

Secondary

Measure	Time frame
Geometric 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	—

Contacts

Public ContactContact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp+81-3-6225-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026