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

* is acutely ill or febrile 72 hours prior to or at screening or dosing (part b and part c). fever is defined as a body temperature ≥38.0°celsius/100.4°fahrenheit. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled/dosed at the discretion of the investigator. * is pregnant or breastfeeding. * (part a only) known history of sars-cov-2 infection. * prior (part a) or concurrent (part b and part c) administration of non-study coronavirus (sars-cov, middle east respiratory syndrome \[mers\]-cov) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19. * (part a only) demonstrated inability to comply with the study procedures. * an immediate family member or household member of this study's personnel. * known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. * bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. * has received or plans to receive a vaccine within 28 days prior to the first dose (day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (ip) (except for seasonal influenza vaccine). * (part a only) has participated in an interventional clinical study within 28 days prior to the day of enrollment. * immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, and recurrent severe infections. * has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to ip dose administration (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). * has received systemic immunoglobulins or blood products within 3 months prior to the day of ip dose administration. * has donated ≥450 milliliters (ml) of blood products within 28 days prior to ip dose administration.

* is acutely ill or febrile 72 hours prior to or at screening or dosing (part b and part c). fever is defined as a body temperature ≥38.0°celsius/100.4°fahrenheit. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled/dosed at the discretion of the investigator. * is pregnant or breastfeeding. * (part a only) known history of sars-cov-2 infection. * prior (part a) or concurrent (part b and part c) administration of non-study coronavirus (sars-cov, middle east respiratory syndrome \[mers\]-cov) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19. * (part a only) demonstrated inability to comply with the study procedures. * an immediate family member or household member of this study's personnel. * known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. * bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. * has received or plans to receive a vaccine within 28 days prior to the first dose (day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (ip) (except for seasonal influenza vaccine). * (part a only) has participated in an interventional clinical study within 28 days prior to the day of enrollment. * immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, and recurrent severe infections. * has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to ip dose administration (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). * has received systemic immunoglobulins or blood products within 3 months prior to the day of ip dose administration. * has donated ≥450 milliliters (ml) of blood products within 28 days prior to ip dose administration.

May 20, 2022, 9 a.m. usa

is acutely ill or febrile 72 hours prior to or at screening or dosing (part b and part c). fever is defined as a body temperature ≥38.0°celsius/100.4°fahrenheit. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled/dosed at the discretion of the investigator. is pregnant or breastfeeding. (part a only) known history of sars-cov-2 infection. prior (part a) or concurrent (part b and part c) administration of non-study coronavirus (sars-cov, middle east respiratory syndrome [mers]-cov) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19. (part a only) demonstrated inability to comply with the study procedures. an immediate family member or household member of this study's personnel. known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. has received or plans to receive a vaccine within 28 days prior to the first dose (day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (ip) (except for seasonal influenza vaccine). (part a only) has participated in an interventional clinical study within 28 days prior to the day of enrollment. immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, and recurrent severe infections. has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to ip dose administration (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). has received systemic immunoglobulins or blood products within 3 months prior to the day of ip dose administration. has donated ≥450 milliliters (ml) of blood products within 28 days prior to ip dose administration.

is acutely ill or febrile 72 hours prior to or at screening or dosing (part b and part c). fever is defined as a body temperature ≥38.0°celsius/100.4°fahrenheit. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled/dosed at the discretion of the investigator. is pregnant or breastfeeding. (part a only) known history of sars-cov-2 infection. prior (part a) or concurrent (part b and part c) administration of non-study coronavirus (sars-cov, middle east respiratory syndrome [mers]-cov) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19. (part a only) demonstrated inability to comply with the study procedures. an immediate family member or household member of this study's personnel. known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. has received or plans to receive a vaccine within 28 days prior to the first dose (day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (ip) (except for seasonal influenza vaccine). (part a only) has participated in an interventional clinical study within 28 days prior to the day of enrollment. immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, and recurrent severe infections. has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to ip dose administration (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). has received systemic immunoglobulins or blood products within 3 months prior to the day of ip dose administration. has donated ≥450 milliliters (ml) of blood products within 28 days prior to ip dose administration.

Dec. 14, 2021, 1 a.m. usa

is acutely ill or febrile 72 hours prior to or at screening or dosing (part b and part c). fever is defined as a body temperature ≥38.0°celsius/100.4°fahrenheit. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled/dosed at the discretion of the investigator. is pregnant or breastfeeding. (part a only) known history of sars-cov-2 infection. (part a only) prior administration of an investigational coronavirus (sars-cov, middle east respiratory syndrome [mers]-cov) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19. (part a only) demonstrated inability to comply with the study procedures. (part a only) an immediate family member or household member of this study's personnel. known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. has received or plans to receive a vaccine within 28 days prior to the first dose (day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (except for seasonal influenza vaccine). has participated in an interventional clinical study within 28 days prior to the day of enrollment. (part a only) immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, and recurrent severe infections. (part a only) has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. (part a only) has donated ≥450 milliliters (ml) of blood products within 28 days prior to screening.

is acutely ill or febrile 72 hours prior to or at screening or dosing (part b and part c). fever is defined as a body temperature ≥38.0°celsius/100.4°fahrenheit. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled/dosed at the discretion of the investigator. is pregnant or breastfeeding. (part a only) known history of sars-cov-2 infection. (part a only) prior administration of an investigational coronavirus (sars-cov, middle east respiratory syndrome [mers]-cov) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19. (part a only) demonstrated inability to comply with the study procedures. (part a only) an immediate family member or household member of this study's personnel. known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. has received or plans to receive a vaccine within 28 days prior to the first dose (day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (except for seasonal influenza vaccine). has participated in an interventional clinical study within 28 days prior to the day of enrollment. (part a only) immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, and recurrent severe infections. (part a only) has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. (part a only) has donated ≥450 milliliters (ml) of blood products within 28 days prior to screening.

Feb. 18, 2021, 12:31 a.m. usa

- is acutely ill or febrile 72 hours prior to or at screening. fever is defined as a body temperature ≥38.0°celsius/100.4°fahrenheit. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. - is pregnant or breastfeeding. - (part a only) known history of sars-cov-2 infection. - prior administration of an investigational coronavirus (sars-cov, middle east respiratory syndrome [mers]-cov) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19. - (part a only) demonstrated inability to comply with the study procedures. - (part a only) an immediate family member or household member of this study's personnel. - known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. - bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. - has received or plans to receive a vaccine within 28 days prior to the first dose (day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (except for seasonal influenza vaccine). - has participated in an interventional clinical study within 28 days prior to the day of enrollment. - immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, and recurrent severe infections. - has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). - has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. - has donated ≥450 milliliters (ml) of blood products within 28 days prior to screening.

- is acutely ill or febrile 72 hours prior to or at screening. fever is defined as a body temperature ≥38.0°celsius/100.4°fahrenheit. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. - is pregnant or breastfeeding. - (part a only) known history of sars-cov-2 infection. - prior administration of an investigational coronavirus (sars-cov, middle east respiratory syndrome [mers]-cov) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19. - (part a only) demonstrated inability to comply with the study procedures. - (part a only) an immediate family member or household member of this study's personnel. - known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. - bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. - has received or plans to receive a vaccine within 28 days prior to the first dose (day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (except for seasonal influenza vaccine). - has participated in an interventional clinical study within 28 days prior to the day of enrollment. - immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, and recurrent severe infections. - has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). - has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. - has donated ≥450 milliliters (ml) of blood products within 28 days prior to screening.

Oct. 26, 2020, 11:31 p.m. usa

- is acutely ill or febrile 72 hours prior to or at screening. fever is defined as a body temperature ≥38.0°c/100.4°f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. - is pregnant or breastfeeding. - known history of sars-cov-2 infection. - prior administration of an investigational coronavirus (sars-cov, middle east respiratory syndrome [mers]-cov) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19. - demonstrated inability to comply with the study procedures. - an immediate family member or household member of this study's personnel. - history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. - bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. - has received or plans to receive a vaccine within 28 days prior to the first dose (day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (except for seasonal influenza vaccine). - has participated in an interventional clinical study within 28 days prior to the day of enrollment. - immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, and recurrent severe infections. - has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). topical tacrolimus is allowed if not used within 14 days prior to screening. - has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. - has donated ≥450 milliliters (ml) of blood products within 28 days prior to screening.

- is acutely ill or febrile 72 hours prior to or at screening. fever is defined as a body temperature ≥38.0°c/100.4°f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. - is pregnant or breastfeeding. - known history of sars-cov-2 infection. - prior administration of an investigational coronavirus (sars-cov, middle east respiratory syndrome [mers]-cov) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19. - demonstrated inability to comply with the study procedures. - an immediate family member or household member of this study's personnel. - history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. - bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. - has received or plans to receive a vaccine within 28 days prior to the first dose (day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (except for seasonal influenza vaccine). - has participated in an interventional clinical study within 28 days prior to the day of enrollment. - immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, and recurrent severe infections. - has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). topical tacrolimus is allowed if not used within 14 days prior to screening. - has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. - has donated ≥450 milliliters (ml) of blood products within 28 days prior to screening.