Created at Source Raw Value Validated value
March 10, 2025, 10:20 a.m. usa

Frequency of dosed participants with at least one adverse event (AE) for each DL cohort;Frequency of dosed participants with at least one serious adverse event (SAE) for each DL cohort;Frequency of dosed participants with solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after every investigational medicinal product (IMP) dose for each DL cohort;Frequency of dosed participants with solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) recorded up to 7 days after every IMP dose for each DL cohort;Percentage of dosed participants with abnormal hematology or chemistry laboratory values for each DL cohort;Percentage of dosed participants with grading shifts in hematology or chemistry laboratory for each DL cohort;Percentage of dosed participants with new electrocardiogram (ECG) abnormalities for each DL cohort

Frequency of dosed participants with at least one adverse event (AE) for each DL cohort;Frequency of dosed participants with at least one serious adverse event (SAE) for each DL cohort;Frequency of dosed participants with solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after every investigational medicinal product (IMP) dose for each DL cohort;Frequency of dosed participants with solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) recorded up to 7 days after every IMP dose for each DL cohort;Percentage of dosed participants with abnormal hematology or chemistry laboratory values for each DL cohort;Percentage of dosed participants with grading shifts in hematology or chemistry laboratory for each DL cohort;Percentage of dosed participants with new electrocardiogram (ECG) abnormalities for each DL cohort

June 22, 2024, 8 a.m. usa

Frequency of participants with at least one adverse event (AE) for each DL cohort;Frequency of participants with at least one serious adverse event (SAE) for each DL cohort;Frequency of participants with solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after every investigational medicinal product (IMP) dose for each DL cohort;Frequency of participants with solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) recorded up to 7 days after every IMP dose for each DL cohort;Percentage of dosed participants with abnormal hematology or chemistry laboratory values for each DL cohort;Percentage of dosed participants with grading shifts in hematology or chemistry laboratory for each DL cohort;Percentage of dosed participants with new electrocardiogram (ECG) abnormalities for each DL cohort

Frequency of participants with at least one adverse event (AE) for each DL cohort;Frequency of participants with at least one serious adverse event (SAE) for each DL cohort;Frequency of participants with solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after every investigational medicinal product (IMP) dose for each DL cohort;Frequency of participants with solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) recorded up to 7 days after every IMP dose for each DL cohort;Percentage of dosed participants with abnormal hematology or chemistry laboratory values for each DL cohort;Percentage of dosed participants with grading shifts in hematology or chemistry laboratory for each DL cohort;Percentage of dosed participants with new electrocardiogram (ECG) abnormalities for each DL cohort

Aug. 10, 2023, noon usa

Frequency of participants with at least one adverse event (AE) occurring up to 28 days after every IMP dose for each DL cohort;Frequency of participants with at least one serious adverse event (SAE) occurring up to 6 months after every IMP dose for each DL cohort;Frequency of participants with solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after every investigational medicinal product (IMP) dose for each DL cohort;Frequency of participants with solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) recorded up to 7 days after every IMP dose for each DL cohort;Percentage of dosed participants with abnormal hematology and chemistry laboratory values 3 days (Dose 1 sentinel group only) and 7 days after every IMP dose for each DL cohort;Percentage of dosed participants with grading shifts in hematology and chemistry laboratory assessments between baseline and 3 days (Dose 1 sentinel group only) and 7 days after every IPM dose for each DL cohort;Percentage of dosed participants with new electrocardiogram (ECG) abnormalities 3 days (Dose 1 sentinel group only) and 7 days after every IMP dose for each DL cohort

Frequency of participants with at least one adverse event (AE) occurring up to 28 days after every IMP dose for each DL cohort;Frequency of participants with at least one serious adverse event (SAE) occurring up to 6 months after every IMP dose for each DL cohort;Frequency of participants with solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after every investigational medicinal product (IMP) dose for each DL cohort;Frequency of participants with solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) recorded up to 7 days after every IMP dose for each DL cohort;Percentage of dosed participants with abnormal hematology and chemistry laboratory values 3 days (Dose 1 sentinel group only) and 7 days after every IMP dose for each DL cohort;Percentage of dosed participants with grading shifts in hematology and chemistry laboratory assessments between baseline and 3 days (Dose 1 sentinel group only) and 7 days after every IPM dose for each DL cohort;Percentage of dosed participants with new electrocardiogram (ECG) abnormalities 3 days (Dose 1 sentinel group only) and 7 days after every IMP dose for each DL cohort

Dec. 28, 2022, midnight usa

Frequency of participants with at least one adverse event (AE) occurring up to 28 days after IMP administration;Frequency of participants with at least one serious adverse event (SAE) occurring up to 6 months after IMP administration;Frequency of participants with solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after investigational medicinal product (IMP) administration;Frequency of participants with solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) recorded up to 7 d after IMP administration;Percentage of dosed participants with abnormal hematology and chemistry laboratory values 3 days (sentinel group only) and 7 days after each dose;Percentage of dosed participants with grading shifts in hematology and chemistry laboratory assessments between baseline and 3 days (sentinel group only) and 7 days after each dose;Percentage of dosed participants with new electrocardiogram (ECG) abnormalities 3 days (sentinel group only) and 7 days after each dose

Frequency of participants with at least one adverse event (AE) occurring up to 28 days after IMP administration;Frequency of participants with at least one serious adverse event (SAE) occurring up to 6 months after IMP administration;Frequency of participants with solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after investigational medicinal product (IMP) administration;Frequency of participants with solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) recorded up to 7 d after IMP administration;Percentage of dosed participants with abnormal hematology and chemistry laboratory values 3 days (sentinel group only) and 7 days after each dose;Percentage of dosed participants with grading shifts in hematology and chemistry laboratory assessments between baseline and 3 days (sentinel group only) and 7 days after each dose;Percentage of dosed participants with new electrocardiogram (ECG) abnormalities 3 days (sentinel group only) and 7 days after each dose

Sept. 17, 2022, 2:30 a.m. usa

Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose;Frequency of solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) recorded up to 7 d after each dose;Percentage of participants receiving each dose of trial vaccine per DL cohort with new electrocardiogram (ECG) abnormalities 3 days (sentinel group only) and 7 days after each dose;Percentage of participants with abnormal hematology and chemistry laboratory values 3 days (sentinel group only) and 7 days after each dose;Percentage of participants with grading shifts in hematology and chemistry laboratory assessments between baseline and 3 days (sentinel group only) and 7 days after each dose;Proportion of participants with at least one adverse event (AE) occurring up to 28 days after each dose;Proportion of participants with at least one serious adverse event (SAE) occurring up to 6 months after their last dose

Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose;Frequency of solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) recorded up to 7 d after each dose;Percentage of participants receiving each dose of trial vaccine per DL cohort with new electrocardiogram (ECG) abnormalities 3 days (sentinel group only) and 7 days after each dose;Percentage of participants with abnormal hematology and chemistry laboratory values 3 days (sentinel group only) and 7 days after each dose;Percentage of participants with grading shifts in hematology and chemistry laboratory assessments between baseline and 3 days (sentinel group only) and 7 days after each dose;Proportion of participants with at least one adverse event (AE) occurring up to 28 days after each dose;Proportion of participants with at least one serious adverse event (SAE) occurring up to 6 months after their last dose