A randomized, double-blind, controlled study of KIB-PCI in Japanese healthy adult volunteers

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221923

Enrollment

800

Registered

2012-09-20

Start date

2012-09-20

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

Prophylaxis of new type of influenza virus infection

Interventions

investigational material(s) Generic name etc : KIB-PCI INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : intramuscula

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Japanese healthy adult volunteers

Exclusion criteria

Exclusion criteria: 1) Subjects with a history of influenza A (H5N1) virus infection 2) Subjects who have received influenza A (H5N1) vaccine

Design outcomes

Primary

Measure	Time frame
SRH antibody titer against H5 antigen	—

Secondary

Measure	Time frame
HI antibody titer against H5 antigen Neutralizing antibody titer against H5N1 influenza virus	—

Outcome results

None listed

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