COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2031220032

Clinical Development Dept.

clinical-trials@meiji.com

2022-04-22

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

(1) Healthy Japanese pediatric subjects aged 6 months to < 18 years at the informed consent (regardless of sex). Pediatric subjects with underlying diseases that are in a stable state will be included.(2) Subjects who have given written informed consent from their legally acceptable representatives

(1) Subjects who are infected with novel coronavirus (hereinafter, SARS-CoV-2) or have a history of infection (based on the interview with subjects legally acceptable representatives)(2) Subjects who have had close contact with a person infected with SARS-CoV-2 (excluding those whose infection was denied by a test) (based on the interview with subjects legally acceptable representatives)(3) Subjects who have received a COVID-19 vaccine (including unapproved vaccines) in the past(4) Subjects with a known history of anaphylaxis due to KD-414 or its ingredient (thimerosal).(5) Female subjects who are pregnant, may be pregnant, are desiring to become pregnant before completion of the follow-up test, or are breast-feeding.

2

Fushimi Hideki

0

18

Japan

Healthy volunteers

N/A

600

Geometric mean titer of neutralizing antibodies against SARS-CoV-2 (D614) pseudovirus 28 days after the second and third doses of KD-414

Phase 2/Phase 3

[{"arm_notes": "0.25 mL", "treatment_id": 703, "treatment_name": "Kd-414", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.5 mL", "treatment_id": 703, "treatment_name": "Kd-414", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]