A retrospective cohort study of the safety and persistence of immunity to SARS-CoV-2 vaccine in children in Izunokuni
Not Applicable
- Conditions
- Children aged 5-11 years living in Izu no Kuni City, Shizuoka
- Registration Number
- JPRN-UMIN000046980
- Lead Sponsor
- Juntendo University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1700
Inclusion Criteria
Not provided
Exclusion Criteria
Children presenting with fever at the time of vaccination The child is suffering from a serious acute illness. Children with conditions that make them inappropriate for vaccination. Any other person who is judged by the principal investigator to be unsuitable as a research subject.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Epidemiological study and safety assessment All children and their parents presenting for SARS-CoV-2 vaccination will be informed about the questionnaire and consenting patients will be allocated anonymously for enrolment. Children who agree to be observed retrospectively will be included in a separate database. The incidence of post-inoculation symptoms will be monitored, distinguishing between local and progressive adverse reactions.
- Secondary Outcome Measures
Name Time Method Immune persistence A separate database will be created for children who agree to be observed retrospectively. Subsequent infection status and antibody testing (if desired) will be carried out.