Created at Source Raw Value Validated value
March 27, 2022, 4 p.m. usa

Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose;Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose;The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring up to 28 Days After Boost Immunization or After Prime Immunization (if no Boost Immunization);The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Prime Immunization up to Boost Immunization or 28 Days After Prime Immunization

Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose;Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose;The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring up to 28 Days After Boost Immunization or After Prime Immunization (if no Boost Immunization);The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Prime Immunization up to Boost Immunization or 28 Days After Prime Immunization

June 27, 2021, 2:30 a.m. usa

Solicited local reactions at the injection site (pain/tenderness, erythema/redness, induration/swelling) recorded up to 7 days after each immunization;Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7 days after each immunization;The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28 days after the boost immunization;The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE) occurring after prime immunization up to boost immunization or 28 days after prime immunization

Solicited local reactions at the injection site (pain/tenderness, erythema/redness, induration/swelling) recorded up to 7 days after each immunization;Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7 days after each immunization;The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28 days after the boost immunization;The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE) occurring after prime immunization up to boost immunization or 28 days after prime immunization

Feb. 5, 2021, 12:31 a.m. usa

Solicited local reactions at the injection site (pain/tenderness, erythema/redness, induration/swelling) recorded up to 7 days after each immunization.;Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7 days after each immunization.;The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28 days after the boost immunization.;The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE) occurring up to 21 days after the prime immunization.

Solicited local reactions at the injection site (pain/tenderness, erythema/redness, induration/swelling) recorded up to 7 days after each immunization.;Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7 days after each immunization.;The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28 days after the boost immunization.;The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE) occurring up to 21 days after the prime immunization.

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

Solicited local reactions at the injection site (pain/tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization.;Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization.;The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the boost immunization.;The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE) occurring up to 21±2 days after the prime immunization.

Solicited local reactions at the injection site (pain/tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization.;Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization.;The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the boost immunization.;The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE) occurring up to 21±2 days after the prime immunization.