COVID-19
Conditions
Interventions
None listed
Sponsors
Juntendo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Individuals aged 12 years or older who have completed their initial SARS-CoV-2 vaccination and have received an additional dose of the after the specified vaccination interval since their previous vaccination. 2)Individuals who require blood sampling for antibody titer determination should, in principle, be able to visit the relevant medical institution for a minimum 6-month survey period. For those participating solely in the survey, the survey form can be submitted by mail.3) 3)Vaccinated individuals with written consent: For those aged 12 to 15: Individuals who have received an explanation of the research and have provided informed assent with written informed consent from a parent or guardian. For those aged 16 to 17: Individuals who have received an explanation of the research and have provided informed consent, along with written informed consent from a parent or guardian. For those 18 years of age or older: Individuals who have provided written informed consent for participation in the research 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 booster vaccination recipients of the Newly developed SARS-CoV-2 Omicron Strain XBB.1.5 Vaccine in Japan | — |
Secondary
| Measure | Time frame |
|---|---|
| Breakthrough infection rate up to 12 months after the last SARS-CoV-2 vaccination Serious adverse events up to 12 months after vaccination (regardless of causality) Changes in COVID-19 antibody titer up to 12 months after vaccination (some of the survey subjects) | — |
Countries
Japan
Contacts
Public ContactMorikuni Tobita
SARS-CoV-2 vaccine Research Secretariat Clinical Research and Trial Center, Juntendo University Hospital
Outcome results
None listed