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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049533

Enrollment

6000

Registered

2022-11-16

Start date

2022-10-18

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: Those who have been vaccinated with the vaccine under investigation Persons over 12 years old (Comirnaty) or 18 years old (Spikevax) 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 the bivalent SARS-CoV-2 booster vaccination	—

Secondary

Measure	Time frame
1) Breakthrough infection rate up to 12 months after the bivalent SARS-CoV-2 booster vaccination 2) Serious adverse events up to 12 months after the bivalent SARS-CoV-2 vaccine (regardless of causality) 3) Changes in COVID-19 antibody titer up to 12 months after inoculation (part of the survey subjects) This may not be investigated if booster is given before 12 months	—

Countries

Japan

Contacts

Public ContactSuminobu Ito

Juntendo University Medical Technology Innovation Center

sito@juntendo.ac.jp03-3813-3111

Outcome results