COVID-19
Conditions
Interventions
None listed
Sponsors
Juntendo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Initial Vaccination Recipient: 1)Individuals aged 12 years or older who have never received a COVID-19 vaccine and are receiving their first dose of the vaccine, regardless of their infection history. 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)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. Booster Vaccination Recipient: 1)Individuals aged 12 years or older who have completed their initial SARS-CoV-2 vaccination and have received an additional dose of the vaccine 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: the same as initial vaccination recipient.
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 initial or booster recipients of SARS-CoV-2 vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Breakthrough infection rate up to 12 months after the final vaccination of SARS-CoV-2 vaccine. 2) Serious adverse events up to 12 months after the final vaccination of SARS-CoV-2 vaccine (regardless of causality). 3) Changes in COVID-19 antibody titer up to 12 months after the final vaccination of SARS-CoV-2 vaccine (some of the survey subjects). This may not be investigated if booster is given before 12 months. | — |
Countries
Japan
Contacts
Public ContactMorikuni Tobita
SARS-CoV-2 vaccine Research Secretariat, Juntendo University Clinical Research and Trial Center, Juntendo University Hospital
Outcome results
None listed