KD-414 Pediatric Phase II/III study (COVID-19)
- Conditions
- Prevention of COVID-19 infection
- Registration Number
- JPRN-jRCT2031220032
- Lead Sponsor
- Fushimi Hideki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Geometric mean titer of neutralizing antibodies against SARS-CoV-2 (D614) pseudovirus 28 days after the second and third doses of KD-414
- Secondary Outcome Measures
Name Time Method