Prevention of COVID-19 infection
Conditions
Interventions
Administer intramuscularly a dose of 0.25 mL or 0.5 mL twice at an interval of 28 days. A dose of 0.25 mL or 0.5 mL is injected intramuscularly at 13 weeks after the second dose.Geometric mean titer o
Sponsors
Fushimi Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titer of neutralizing antibodies against SARS-CoV-2 (D614) pseudovirus 28 days after the second and third doses of KD-414 | — |
Contacts
Public ContactClinical Development Dept.
Meiji Seika Pharma Co., Ltd.
Outcome results
None listed