A-04-01D-2

A Phase II/III, Randomized, Double-Blind, Parallel-Group Study to Assess the Safety and Immunogenicity of Intramuscular A-04-01D (H5N1 influenza vaccine) in Healthy Adult Japanese Volunteers

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221139

Enrollment

300

Registered

2010-06-28

Start date

2010-06-28

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 H5N1 influenza infection

Interventions

investigational material(s) Generic name etc : A-04-01D INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Intramuscul

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers

Exclusion criteria

Exclusion criteria: Known history of H5N1 influenza or received H5N1 influenza vaccination in the past.

Design outcomes

Primary

Measure	Time frame
1. Neutralizing antibody titer against H5N1 influenza virus 2. HI antibody titer against H5 antigen	—

Outcome results

None listed

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