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Effectiveness and safety of COVID-19 vaccines

Prospective cohort study of effectiveness and safety of COVID-19 vaccines in Osaka, Japan

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1051200143
Enrollment
1500
Registered
2021-03-03
Start date
2021-03-05
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

Coronavirus Disease 2019

Interventions

None listed

Sponsors

Kayeka Hiroshi
Lead Sponsor
Hirota Yoshio
Collaborator
Fukushima Wakaba
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Those who meet all of the following 1), 2), and 3) 1) Persons who meet any of the following (a) to (d) (a) Health care workers at Osaka City (Metropolitan) University Hospital (b) Staff of Osaka City Health Bureau * (c) Faculty / Students of Osaka City (Metropolitan) University School of Medicine / Graduate School of Medicine / Graduate School of Nursing (d) Member of "Osaka Clinical Trial Volunteer Association", Osaka City (Metropolitan) University Hospital # * Including Osaka City Health Center # They will be recruited If the expected number of subjects will not be achieved from (a), (b), and (c) 2) Aged 20-64 years 3) Persons who have voluntarily provided written informed consent for participation

Exclusion criteria

Exclusion criteria: Persons who meet any of the following 1) to 4) 1) Those with contraindications for vaccination 2) Those who have been received with COVID-19 vaccines in the past (including participation in clinical trials or clinical studies) 3) Those who have been diagnosed with COVID-19 in the past 4) Those who are judged to be ineligible for research by the principal investigator or the investigator

Design outcomes

Primary

MeasureTime frame
Immunogenicity: antibody response against SARS-CoV2-Spike protein

Secondary

MeasureTime frame
(a) Immunogenicity: response of neutralizing antibody against SARS-CoV2 (b) Prevention of laboratory-confirmed COVID-19 - PCR positive after disease onset - Serological infection including or limited to asymptomatic cases (c) Prevention of COVID-19-like diseases (d) Occurence of adverse reactions after vaccination (e) Occurence of diseases suspected to be caused by vaccination

Contacts

Public ContactWakaba Fukushima

Department of Public Health, Osaka Metropolitan University Graduate School of Medicine

wakaba@omu.ac.jp+81-6-6645-3756

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026