VN-100 Ph3 non-inferiority study

A randomized, double-blind, confirmatory study of VN-100 in healthy elderly volunteers

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222443

Enrollment

900

Registered

2014-03-28

Start date

2014-04-07

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 influenza infection

Interventions

investigational material(s) Generic name etc : VN-100 INN of investigational material : - Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Intradermal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy elderly Japanese volunteers

Exclusion criteria

Exclusion criteria: 1) Subjects with history of seasonal influenza in the past 6 months 2) Subjects with history of seasonal influenza vaccination in the past 6 months

Design outcomes

Primary

Measure	Time frame
efficacy The difference between the seroconversion rates and the ratio of GMTs of HI antibody titer against three vaccine stains at Day 21 To demonstrate the immunological non-inferiority in terms of the difference between the seroconversion rates (VN-100 seasonalinfluenza vaccine) and the ratio of GMTs (VN-100/seasonal influenza vaccine) of HI antibody titer against three vaccine stains at Day 21. The criteria are as follows. 1)The lower bound of the two-sided 95% CI on the difference between the seroconversion rates exceed -10 percentage points. 2)The lower bound of the two-sided 95% CI on the ratio of the GMTs exceed 2/3. In case the non-inferiority is actually demonstrated, the following criteria regarding superiority are evaluated collaterally.	—

Measure

Time frame

efficacy The difference between the seroconversion rates and the ratio of GMTs of HI antibody titer against three vaccine stains at Day 21 To demonstrate the immunological non-inferiority in terms of the difference between the seroconversion rates (VN-100 seasonalinfluenza vaccine) and the ratio of GMTs (VN-100/seasonal influenza vaccine) of HI antibody titer against three vaccine stains at Day 21. The criteria are as follows. 1)The lower bound of the two-sided 95% CI on the difference between the seroconversion rates exceed -10 percentage points. 2)The lower bound of the two-sided 95% CI on the ratio of the GMTs exceed 2/3. In case the non-inferiority is actually demonstrated, the following criteria regarding superiority are evaluated collaterally.

—

Secondary

Measure	Time frame
efficacy Seroconversion rate, GMTs, and Seroprotection rate of HI antibody titer against three vaccine stains	—

Countries

Japan

Outcome results

None listed

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