Use-result survey of Daichirona for intramuscular injection

JRCT ID: jRCT2031240151

Registered date:11/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Prevention of SARS-CoV-2 infection
• Date of first enrollment: 20/09/2024
• Target sample size: 3000
• Study type: Observational

Outcome(s)

• Primary Outcome: Safety Specifications of Daichirona (shock, anaphylaxis, myocarditis, pericarditis, Guillain-Barre Syndrome, vaccine associated enhanced disease (VAED) and vaccine associated enhancement of respiratory disease (VAERD), safety when administered to pregnant or breastfeeding women)

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Subjects aged 12 years or older who are receiving Daichirona by intramuscular injection for the first time
(2) Subjects who are received Daichirona by intramuscular injection during the contract period (contract period based on the contract with each medical site)
(3) Subjects who are received Daichirona by intramuscular injection during the registration period
(4) Subjects from whom written informed consent was obtained

• Exclude criteria: none

Related Information

• Primary Sponsor: Tanabe Hirokazu