Immune Persistence and Safety Young Children Survey (Aged 6 months - 4 Years) related to the SARS-CoV-2 Vaccination (Initial and Booster Vaccination) in Japan

Immune Persistence and Safety Young Children Survey (Aged 6 months - 4 Years) related to the SARS-CoV-2 Vaccination (Initial and Booster Vaccination) in Japan - Immune Persistence and Safety Young Children Survey related to the SARS-CoV-2 Vaccination in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049534

Enrollment

500

Registered

2022-11-16

Start date

2022-11-14

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

COVID-19

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Those who have been vaccinated with the Pfizer Comirnaty vaccine. 2) Those whose parents consented to participate in the study.

Exclusion criteria

Exclusion criteria: Those who are inappropriate as the subject of the survey determined by the principal investigator

Design outcomes

Primary

Measure	Time frame
Safety up to 4 weeks after the last vaccination of SAR S-CoV-2 vaccine	—

Secondary

Measure	Time frame
1) Breakthrough infection rate up to 6 months after the final vaccination of SARS-CoV-2 vaccine. 2) Serious adverse events up to 6 months after the final vaccination of SARS-CoV-2 vaccine (regardless of causality). 3) Changes in COVID-19 antibody titer up to 6 months after the final vaccination of SARS-CoV-2 vaccine (some of the survey subjects).	—

Countries

Japan

Contacts

Public ContactMorikuni Tobita

SARS-CoV-2 vaccine Research Secretariat, Juntendo University Clinical Research and Trial Center, Juntendo University Hospital

covidvac@juntendo.ac.jp03-3813-3111

Outcome results