Effectiveness and safety of COVID-19 vaccines

JRCT ID: jRCT1051200143

Registered date:03/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Coronavirus Disease 2019
• Date of first enrollment: 05/03/2021
• Target sample size: 1500
• Study type: Observational

Outcome(s)

• Primary Outcome: Immunogenicity: antibody response against SARS-CoV2-Spike protein

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 64age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kayeka Hiroshi
• Secondary Sponsor: Hirota Yoshio,Fukushima Wakaba