臨床研究等提出・公開システム

A randomized, double-blind, comparative study of VN-100 in healthy adult Japanese volunteers

VN-100 Ph1/2

600

To evaluate the dose and dosage of VN-100 comparing subcutaneouly administered influenza HA vaccine in healthy adult and elderly Japanese volunteers

In this study, 600 subjects (20 to 65 years: 300 subjects, 65 years and older: 300 subjects) were enrolled, and all subjects received the 1st or 2nd administered vaccines and completed (20 to 65 years: 296 subjects, 65 years and older: 299 subjects. During this study, 5 subjects discontinued in this study.

- Incidence of AEs was 94.0% (94/100) in VN-100 6 micro g group, 96.0% (96/100) in VN-100 9 micro g group, and 93.0% (93/100) in the 1st administered vaccine group, 96.0% (96/100) in VN-100 15 micro g 2nd administered vaccines group, 72.0% (72/100) in the 1st subcutaneous administered vaccine group, 80.0% (80/100) in the 2st subcutaneous administered vaccine group. - Incidence of injection site AEs was higher in the VN-100 group than in the subcutaneous group. The incidence of injection site erythema, injection site swelling, injection site pruritus, injection site consolidation, and injection site discoloration was higher in the VN-100 group. - Incidence of systemic AEs was not significantly different between each group. Although the incidence of fatigue and headache was high, there was no significant difference in the incidence between the VN-100 group and the subcutaneous group.

- The seroconversion rate in HI antibody titer after 1st vaccination was about the same or higher than in VN-100 group (6 micro g, 9 micro g, and 15 micro g) and subcutaneous group in both the 20 to 65 years and 65 years and older. - The GMT ratio in HI antibody titer after 1st vaccination was about the same or higher than in VN-100 group and subcutaneous group in both the 20 to 65 years and 65 years and older. - The seroprotection rate in HI antibody titer after 1st vaccination was about the same or higher than in VN-100 group and subcutaneous group in both the 20 to 65 years and 65 years and older.

The HI antibody titer during the follow-up period after vaccination was not significantly different between the VN-100 group and the subcutaneous group.

As a result of the immunogenicity and safety of VN-100 in healthy adults and elderly, a good increase in antibody titer and safety were confirmed. The immunogenicity of VN-100 with 6 micro g, 9 micro g, and 15 micro g was similar to subcutaneous influenza HA vaccine.

Oct. 01, 2015

https://www.sciencedirect.com/science/article/pii/S0264410X15012566

No

-

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

April. 01, 2013

Interventional

A multicenter, randomized, active control, double blind, parallel-group study

prevention purpose

1-2

Healthy adult Japanese volunteers

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

Both

Prophylaxis of influenza infection

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

control material(s)
Generic name etc : Influenza HA vaccine
INN of investigational material : -
Therapeutic category code : 631 Vaccines
Dosage and Administration for Investigational material : subcutaneous injection

efficacy
HI antibody titer

efficacy
Neutralizing antibody titer

-

Mar. 18, 2013