Number of Participants with Solicited Local Adverse Events (AEs) at 7 Days Post-vaccination 1
Number of participants with solicited local AEs at 7 days post-vaccination 1 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.
Number of Participants with Solicited Local AEs at 7 Days Post-vaccination 2
Number of participants with solicited local AEs at 7 days post-vaccination 2 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.
Number of Participants with Solicited Local AEs by Severity at 7 Days Post-vaccination 1
Number of participants with solicited local AEs by severity at 7 days post-vaccination 1 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. Severity will be assessed using Food and Drug Administration (FDA) Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Number of Participants with Solicited Local AEs by Severity at 7 Days Post-vaccination 2
Number of participants with solicited local AEs by severity at 7 days post-vaccination 2. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Duration of Solicited Local AEs at 7 Days Post-vaccination 1
Duration of solicited local AEs on at 7 days post-vaccination 1 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site.
Duration of Solicited Local AEs at 7 Days Post-vaccination 2
Duration of solicited local AEs at 7 days post-vaccination 2 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site.
Number of Participants with Solicited Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited systemic AEs at 7 days post-vaccination 1 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature greater than or equal to [>=] 38 degree C).
Number of Participants with Solicited Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited systemic AEs at 7 days post-vaccination 2 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C).
Number of Participants with Solicited Systemic AEs by Severity at 7 Days Post-vaccination 1
Number of participants with solicited systemic AEs by severity at 7 days post-vaccination 1 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C). Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Number of Participants with Solicited Systemic AEs by Severity at 7 Days Post-vaccination 2
Number of participants with solicited systemic AEs by severity at 7 days post-vaccination 2 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea and fever (body temperature >=38 degree C). Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Duration of Solicited Systemic AEs at 7 Days Post-vaccination 1
Duration of solicited systemic AEs on at 7 days post-vaccination 1 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea and fever (body temperature >=38 degree C).
Duration of Solicited Systemic AEs at 7 Days Post-vaccination 2
Duration of solicited systemic AEs on at 7 days post-vaccination 2 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C).
Number of Participants with Solicited Systemic AEs Related to Study Vaccine at 7 Days Post-vaccination 1
Number of participants with solicited systemic AEs related to study vaccine at 7 days post-vaccination 1 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C).
Number of Participants with Solicited Systemic AEs Related to Study Vaccine at 7 Days Post-vaccination 2
Number of participants with solicited systemic AEs related to study vaccine at 7 days post-vaccination 2 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants will be instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs include fatigue, headache, myalgia, nausea, and fever (body temperature >=38 degree C).
Number of Participants with Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs at 28 days post-vaccination 1 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Number of Participants with Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs at 28 days post-vaccination 2 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Number of Participants with Unsolicited AEs by Severity at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs by severity at 28 days post-vaccination 1 by severity will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary. Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Number of Participants with Unsolicited AEs by Severity at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs by severity at 28 days post-vaccination 2 by severity will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned. Severity will be assessed using FDA Toxicity grading scale which includes Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening).
Duration of Unsolicited AEs at 28 Days Post-vaccination 1
Duration of unsolicited AEs at 28 days post-vaccination 1 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Duration of Unsolicited AEs at 28 Days Post-vaccination 2
Duration of unsolicited AEs at 28 days post-vaccination 2 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Number of Participants with Unsolicited AEs Related to Study Vaccine at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs related to study vaccine at 28 days post-vaccination 1 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Number of Participants with Unsolicited AEs Related to Study Vaccine at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs related to study vaccine at 28 days post-vaccination 2 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's diary.
Number of Participants with Serious Adverse Events (SAEs)
An SAE is any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.
Number of Participants with Serious Adverse Events (SAEs) Related to Study Vaccine
An SAE is any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.