Created at Source Raw Value Validated value
June 25, 2024, noon usa

potential participants who meet any of the following exclusion criteria will be excluded from enrolment and participation in the study: 1. the participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a patient under investigation (pui) or has a body temperature ≥38.0ºc (100.4°f) within 24 hours prior to the planned study vaccination. assignment may be made at a later date is permitted at the discretion of the investigator. please notify the sponsor (or medical monitor) of this decision. 2. contraindication to ad26.cov2.s according to labelling of the product. for example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine;refer to the ib (ib edition 5 ad26.cov2.s 2021 and its addenda). 3. pregnant or planning to become pregnant within 3 months after study vaccine administration 4. participant has a history or current condition as follows 1. known documented history of covid-19 infection prior to enrollment 2. any confirmed or suspected immunosuppressive or immunodeficient state. 3. heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia. 4. acute polyneuropathy (e.g. guillain-barré syndrome). 5. capillary leak syndrome 6. contraindication to im injections and blood draws e.g., bleeding disorders. 7. an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well being) or that could prevent, limit, or confound the protocol-specified assessments. 8. major psychiatric illness which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures. 5. if the participant received or plans to receive: 1. licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine. 2. other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine. 3. treatment with immunoglobulins (ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study. 6. if the participant cannot communicate reliably with the investigator, or, in the opinion of the investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of vaccination and observation. 7. employee of the study center directly involved with the proposed study or with study investigators.

potential participants who meet any of the following exclusion criteria will be excluded from enrolment and participation in the study: 1. the participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a patient under investigation (pui) or has a body temperature ≥38.0ºc (100.4°f) within 24 hours prior to the planned study vaccination. assignment may be made at a later date is permitted at the discretion of the investigator. please notify the sponsor (or medical monitor) of this decision. 2. contraindication to ad26.cov2.s according to labelling of the product. for example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine;refer to the ib (ib edition 5 ad26.cov2.s 2021 and its addenda). 3. pregnant or planning to become pregnant within 3 months after study vaccine administration 4. participant has a history or current condition as follows 1. known documented history of covid-19 infection prior to enrollment 2. any confirmed or suspected immunosuppressive or immunodeficient state. 3. heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia. 4. acute polyneuropathy (e.g. guillain-barré syndrome). 5. capillary leak syndrome 6. contraindication to im injections and blood draws e.g., bleeding disorders. 7. an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well being) or that could prevent, limit, or confound the protocol-specified assessments. 8. major psychiatric illness which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures. 5. if the participant received or plans to receive: 1. licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine. 2. other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine. 3. treatment with immunoglobulins (ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study. 6. if the participant cannot communicate reliably with the investigator, or, in the opinion of the investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of vaccination and observation. 7. employee of the study center directly involved with the proposed study or with study investigators.

Feb. 23, 2022, 6:30 p.m. usa

potential participants who meet any of the following exclusion criteria will be excluded from enrolment and participation in the study: the participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a patient under investigation (pui) or has a body temperature ≥38.0ºc (100.4°f) within 24 hours prior to the planned study vaccination. assignment may be made at a later date is permitted at the discretion of the investigator. please notify the sponsor (or medical monitor) of this decision. contraindication to ad26.cov2.s according to labelling of the product. for example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine;refer to the ib (ib edition 5 ad26.cov2.s 2021 and its addenda). pregnant or planning to become pregnant within 3 months after study vaccine administration participant has a history or current condition as follows known documented history of covid-19 infection prior to enrollment any confirmed or suspected immunosuppressive or immunodeficient state. heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia. acute polyneuropathy (e.g. guillain-barré syndrome). capillary leak syndrome contraindication to im injections and blood draws e.g., bleeding disorders. an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well being) or that could prevent, limit, or confound the protocol-specified assessments. major psychiatric illness which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures. if the participant received or plans to receive: licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine. other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine. treatment with immunoglobulins (ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study. if the participant cannot communicate reliably with the investigator, or, in the opinion of the investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of vaccination and observation. employee of the study center directly involved with the proposed study or with study investigators.

potential participants who meet any of the following exclusion criteria will be excluded from enrolment and participation in the study: the participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a patient under investigation (pui) or has a body temperature ≥38.0ºc (100.4°f) within 24 hours prior to the planned study vaccination. assignment may be made at a later date is permitted at the discretion of the investigator. please notify the sponsor (or medical monitor) of this decision. contraindication to ad26.cov2.s according to labelling of the product. for example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine;refer to the ib (ib edition 5 ad26.cov2.s 2021 and its addenda). pregnant or planning to become pregnant within 3 months after study vaccine administration participant has a history or current condition as follows known documented history of covid-19 infection prior to enrollment any confirmed or suspected immunosuppressive or immunodeficient state. heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia. acute polyneuropathy (e.g. guillain-barré syndrome). capillary leak syndrome contraindication to im injections and blood draws e.g., bleeding disorders. an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well being) or that could prevent, limit, or confound the protocol-specified assessments. major psychiatric illness which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures. if the participant received or plans to receive: licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine. other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine. treatment with immunoglobulins (ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study. if the participant cannot communicate reliably with the investigator, or, in the opinion of the investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of vaccination and observation. employee of the study center directly involved with the proposed study or with study investigators.

Dec. 3, 2021, 11:30 p.m. usa

potential participants who meet any of the following exclusion criteria will be excluded from enrolment and participation in the study: the participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a patient under investigation (pui) or has a body temperature ≥38.0ºc (100.4°f) within 24 hours prior to the planned study vaccination. assignment may be made at a later date is permitted at the discretion of the investigator. please notify the sponsor (or medical monitor) of this decision. contraindication to ad26.cov2.s according to labelling of the product. for example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine). participant has a history or current condition as follows known documented history of covid-19 infection prior to enrollment any confirmed or suspected immunosuppressive or immunodeficient state. heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia. acute polyneuropathy (e.g. guillain-barré syndrome). capillary leak syndrome contraindication to im injections and blood draws e.g., bleeding disorders. an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well being) or that could prevent, limit, or confound the protocol-specified assessments. major psychiatric illness which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures. if the participant received or plans to receive: licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine. other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine. treatment with immunoglobulins (ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study. if the participant cannot communicate reliably with the investigator, or, in the opinion of the investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of vaccination and observation. employee of the study center directly involved with the proposed study or with study investigators.

potential participants who meet any of the following exclusion criteria will be excluded from enrolment and participation in the study: the participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a patient under investigation (pui) or has a body temperature ≥38.0ºc (100.4°f) within 24 hours prior to the planned study vaccination. assignment may be made at a later date is permitted at the discretion of the investigator. please notify the sponsor (or medical monitor) of this decision. contraindication to ad26.cov2.s according to labelling of the product. for example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine). participant has a history or current condition as follows known documented history of covid-19 infection prior to enrollment any confirmed or suspected immunosuppressive or immunodeficient state. heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia. acute polyneuropathy (e.g. guillain-barré syndrome). capillary leak syndrome contraindication to im injections and blood draws e.g., bleeding disorders. an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well being) or that could prevent, limit, or confound the protocol-specified assessments. major psychiatric illness which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures. if the participant received or plans to receive: licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine. other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine. treatment with immunoglobulins (ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study. if the participant cannot communicate reliably with the investigator, or, in the opinion of the investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of vaccination and observation. employee of the study center directly involved with the proposed study or with study investigators.

Nov. 16, 2021, 6:30 p.m. usa

potential participants who meet any of the following exclusion criteria will be excluded from enrolment and participation in the study: the participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a patient under investigation (pui) or has a body temperature ≥38.0ºc (100.4°f) within 24 hours prior to the planned study vaccination. assignment may be made at a later date is permitted at the discretion of the investigator. please notify the sponsor (or medical monitor) of this decision. contraindication to ad26.cov2.s according to labelling of the product. for example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine; refer to the ib (ib edition 5 ad26.cov2.s 2021 and its addenda). participant has a history or current condition as follows known documented history of covid-19 infection prior to enrollment any confirmed or suspected immunosuppressive or immunodeficient state. heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia. acute polyneuropathy (e.g. guillain-barré syndrome). capillary leak syndrome contraindication to im injections and blood draws e.g., bleeding disorders. an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well being) or that could prevent, limit, or confound the protocol-specified assessments. major psychiatric illness which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures. if the participant received or plans to receive: licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine. other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine. treatment with immunoglobulins (ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study. if the participant cannot communicate reliably with the investigator, or, in the opinion of the investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of vaccination and observation. employee of the study center directly involved with the proposed study or with study investigators.

potential participants who meet any of the following exclusion criteria will be excluded from enrolment and participation in the study: the participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a patient under investigation (pui) or has a body temperature ≥38.0ºc (100.4°f) within 24 hours prior to the planned study vaccination. assignment may be made at a later date is permitted at the discretion of the investigator. please notify the sponsor (or medical monitor) of this decision. contraindication to ad26.cov2.s according to labelling of the product. for example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine; refer to the ib (ib edition 5 ad26.cov2.s 2021 and its addenda). participant has a history or current condition as follows known documented history of covid-19 infection prior to enrollment any confirmed or suspected immunosuppressive or immunodeficient state. heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia. acute polyneuropathy (e.g. guillain-barré syndrome). capillary leak syndrome contraindication to im injections and blood draws e.g., bleeding disorders. an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well being) or that could prevent, limit, or confound the protocol-specified assessments. major psychiatric illness which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures. if the participant received or plans to receive: licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine. other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine. treatment with immunoglobulins (ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study. if the participant cannot communicate reliably with the investigator, or, in the opinion of the investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of vaccination and observation. employee of the study center directly involved with the proposed study or with study investigators.

Nov. 8, 2021, 3:30 p.m. usa

potential participants who meet any of the following exclusion criteria will be excluded from enrolment and participation in the study: 1. the participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a patient under investigation (pui) or has a body temperature ≥38.0ºc (100.4°f) within 24 hours prior to the planned study vaccination. assignment may be made at a later date is permitted at the discretion of the investigator. please notify the sponsor (or medical monitor) of this decision. 2. contraindication to ad26.cov2.s according to labelling of the product. for example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine; refer to the ib (ib edition 5 ad26.cov2.s 2021 and its addenda). 3. participant has a history or current condition as follows 1. known documented history of covid-19 infection prior to enrollment 2. any confirmed or suspected immunosuppressive or immunodeficient state. 3. heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia. 4. acute polyneuropathy (e.g. guillain-barré syndrome). 5. capillary leak syndrome 6. contraindication to im injections and blood draws e.g., bleeding disorders. 7. an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well being) or that could prevent, limit, or confound the protocol-specified assessments. 8. major psychiatric illness which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures. 4. if the participant received or plans to receive: 1. licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine. 2. other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine. 3. treatment with immunoglobulins (ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study. 5. if the participant cannot communicate reliably with the investigator, or, in the opinion of the investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of vaccination and observation. 6. employee of the study center directly involved with the proposed study or with study investigators.

potential participants who meet any of the following exclusion criteria will be excluded from enrolment and participation in the study: 1. the participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a patient under investigation (pui) or has a body temperature ≥38.0ºc (100.4°f) within 24 hours prior to the planned study vaccination. assignment may be made at a later date is permitted at the discretion of the investigator. please notify the sponsor (or medical monitor) of this decision. 2. contraindication to ad26.cov2.s according to labelling of the product. for example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine; refer to the ib (ib edition 5 ad26.cov2.s 2021 and its addenda). 3. participant has a history or current condition as follows 1. known documented history of covid-19 infection prior to enrollment 2. any confirmed or suspected immunosuppressive or immunodeficient state. 3. heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia. 4. acute polyneuropathy (e.g. guillain-barré syndrome). 5. capillary leak syndrome 6. contraindication to im injections and blood draws e.g., bleeding disorders. 7. an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well being) or that could prevent, limit, or confound the protocol-specified assessments. 8. major psychiatric illness which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures. 4. if the participant received or plans to receive: 1. licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine. 2. other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine. 3. treatment with immunoglobulins (ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study. 5. if the participant cannot communicate reliably with the investigator, or, in the opinion of the investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of vaccination and observation. 6. employee of the study center directly involved with the proposed study or with study investigators.