A retrospective cohort study of the safety and persistence of immunity to SARS-CoV-2 vaccine in children in Izunokuni

A retrospective epidemiological study of the safety and persistence of immunity to SARS-CoV-2 vaccination in children - IzuNoKuni SARS-CoV-2 Vaccine Study in Children

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046980

Enrollment

1700

Registered

2022-02-22

Start date

2022-03-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children aged 5-11 years living in Izu no Kuni City, Shizuoka

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children present in Izunokuni and vaccinated with SARS-CoV-2 vaccine (Cominaty, Pfizer)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactYosuke Baba

Juntendo University Shizuoka Hospital Department of Pediatrics

youbaba@juntendo.ac.jp0559483111

Outcome results