Created at Source Raw Value Validated value
Jan. 13, 2022, 11 p.m. oms

1.Subjects who tested positive for SARS-CoV-2 by a PCR test at screening,2.Subjects with COVID-19,3.Close contact with COVID-19 patients at the time of the inoculation4.Subjects with a history of administration of anti-SARS-CoV-2 monoclonal antibody within three months before the inoculation of the investigational drug5.Subjects who have developed anaphylaxis due to a component of the investigational drug (thimerosal)6.Pregnant women, women who may be pregnant, women who wish to become pregnant by four weeks after the inoculation of the investigational drug, women who are breastfeeding7.Subjects with progressive ossifying fibrodysplasia8.Subjects with underlying diseases such as severe cardiovascular disease, kidney disease, liver disease, blood disease, growth disorder, respiratory disease and diabetes etc9.Subjects who have had the fever (excluding the feeling of heat at the inoculation site) within two days after the vaccination except for the COVID-19 preventive vaccine, and those who have had symptoms suspected of allergies such as a systemic rash (cause) Not applicable if it is confirmed that the ingredient is not contained in the investigational drug)10.Subjects who have a history of convulsions in the past11.Subjects having been diagnosed with immunodeficiency or having a close relative with congenital immunodeficiency,12.Subjects who have experienced documented anaphylaxis caused by an ingredient of the investigational product (thimerosal),13.Subjects who participated in other clinical trials or clinical trials within 120 days from the date of inoculation of the study drug, or subjects who plan to participate by the end of the follow-up period of this study.14.Subjects who have received transfusion or a gamma globulin preparation within three months (90 days), or a bolus therapy (>=200 mg/kg) with a gamma globulin preparation within six months (180 days), prior to the date of the first dose of study product,15.Subject who have received any treatments that may affect the immune function within six months (180 days) prior to the date of the first dose of study product, including radiotherapy, immunosuppressants (except for external use), immunosuppressive therapy, antirheumatics, adrenocorticotropic hormones, or corticosteroids (treatment at prednisolone equivalent doses >=2 mg/kg/day for >=14 days, except for external use.),16.Subjects who are judged by the principal investigator or the sub-investigator as ineligible for the study as a result of the screening test,17.Subject being otherwise ineligible for this study in the principal investigator's or sub-investigator's opinion.<Subjects who have been infected with SARS-CoV-2 at the time of inoculation of this investigational drug for less than three months or more than 24 months have passed.>

1.Subjects who tested positive for SARS-CoV-2 by a PCR test at screening,2.Subjects with COVID-19,3.Close contact with COVID-19 patients at the time of the inoculation4.Subjects with a history of administration of anti-SARS-CoV-2 monoclonal antibody within three months before the inoculation of the investigational drug5.Subjects who have developed anaphylaxis due to a component of the investigational drug (thimerosal)6.Pregnant women, women who may be pregnant, women who wish to become pregnant by four weeks after the inoculation of the investigational drug, women who are breastfeeding7.Subjects with progressive ossifying fibrodysplasia8.Subjects with underlying diseases such as severe cardiovascular disease, kidney disease, liver disease, blood disease, growth disorder, respiratory disease and diabetes etc9.Subjects who have had the fever (excluding the feeling of heat at the inoculation site) within two days after the vaccination except for the COVID-19 preventive vaccine, and those who have had symptoms suspected of allergies such as a systemic rash (cause) Not applicable if it is confirmed that the ingredient is not contained in the investigational drug)10.Subjects who have a history of convulsions in the past11.Subjects having been diagnosed with immunodeficiency or having a close relative with congenital immunodeficiency,12.Subjects who have experienced documented anaphylaxis caused by an ingredient of the investigational product (thimerosal),13.Subjects who participated in other clinical trials or clinical trials within 120 days from the date of inoculation of the study drug, or subjects who plan to participate by the end of the follow-up period of this study.14.Subjects who have received transfusion or a gamma globulin preparation within three months (90 days), or a bolus therapy (>=200 mg/kg) with a gamma globulin preparation within six months (180 days), prior to the date of the first dose of study product,15.Subject who have received any treatments that may affect the immune function within six months (180 days) prior to the date of the first dose of study product, including radiotherapy, immunosuppressants (except for external use), immunosuppressive therapy, antirheumatics, adrenocorticotropic hormones, or corticosteroids (treatment at prednisolone equivalent doses >=2 mg/kg/day for >=14 days, except for external use.),16.Subjects who are judged by the principal investigator or the sub-investigator as ineligible for the study as a result of the screening test,17.Subject being otherwise ineligible for this study in the principal investigator's or sub-investigator's opinion.<Subjects who have been infected with SARS-CoV-2 at the time of inoculation of this investigational drug for less than three months or more than 24 months have passed.>