Immune Persistence and Safety Pediatric Survey (Aged 5-11 Years) related to the SARS-CoV-2 Vaccination (Primary series and Booster Vaccination) in Japan

Immune Persistence and Safety Pediatric Survey (Aged 5-11 Years) related to the SARS-CoV-2 Vaccination (Primary series and Booster Vaccination) in Japan - Immune Persistence and Safety Pediatric Cohort Survey on SARS-CoV-2 Vaccination in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047368

Enrollment

1000

Registered

2022-04-02

Start date

2023-09-30

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)Children aged 5 to 11 who received the initial or additional dose of the Pfizer vaccine. 2)Children aged 6 to 11 who received an additional dose of the Moderna vaccine. 3)Regarding the initial series vaccination survey, it targets children who are eligible to participate in the survey from the first dose (aged 5 to 11 at the time of the first dose). 4)Concerning the additional dose (third dose and beyond) vaccination survey, it targets children who can continue to participate from the initial series vaccination survey and children who are eligible to participate in the survey from the additional dose (aged 5 to 11 for Pfizer vaccine and 6 to 11 for Moderna vaccine). 5)Generally, for children aged approximately 5 to 6 (preschoolers, depending on their understanding), after explaining the research study, their willingness to participate is confirmed, and informed consent from the legal guardian is obtained. 6)For children aged 6 to 11 (elementary school students), after explaining the research study, informed assent (typically Assent Document A for grades 1 to 3 and Assent Document B for grades 4 to 6) is obtained from the child, and informed consent is obtained from the legal guardian.

Exclusion criteria

Exclusion criteria: Those who are inappropriate as the subject of the survey determined by the principal investi gator.

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