Immune Persistence and Safety Survey (Cohort Survey) related to the SARS-CoV-2 Booster Vaccination (4th dose) in Japan

Immune Persistence and Safety Survey (Cohort Survey) related to the SARS-CoV-2 Booster Vaccination (4th dose) in Japan - Immune Persistence and Safety Survey related to the SARS-CoV-2 4th Booster Vaccination in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047919

Enrollment

6000

Registered

2022-06-01

Start date

2022-06-03

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 vaccine under investigation 2) Persons over 18 years old who have obtained the written consent of the inoculated person

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 vaccination of SARS-CoV-2 4th booster vaccination	—

Secondary

Measure	Time frame
Breakthrough infection rate up to 12 months after the final vaccination of SARS-CoV-2 booster vaccination SARS-CoV-2 vaccine 4th booster vaccination Serious adverse events up to 12 months after vaccination (regardless of causality) SARS-CoV-2 vaccine 4th booster vaccination Changes in COVID-19 antibody titer up to 12 months after inoculation (part of the survey subjects)	—

Countries

Japan

Contacts

Public ContactMorikuni Tobita

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

covidvac@juntendo.ac.jp03-3813-3111

Outcome results