A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years

Percentage of participants reporting unsolicited adverse events (AEs) within 28 days after the second vaccine dose administered at Day 57

An unsolicited AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention, whether or not considered related to the study intervention and that was not included in a list of solicited events using a Participant Diary.

Time frame: Within 28 days after the second vaccine dose (administered at Day 57)

Percentage of participants reporting medically attended AEs (MAEs)

A MAE is an unsolicited AE for which the participants received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.

Time frame: From Day 1 up to study end at Day 421

Percentage of participants reporting serious adverse events (SAEs)

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient or results in abnormal pregnancy outcomes.

Time frame: From Day 1 up to study end at Day 421

Percentage of participants reporting potential immune-mediated diseases (pIMDs)

PIMDs are a subset of adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Time frame: From Day 1 up to study end at Day 421

Percentage of participants reporting potential orolabial HSV-1 recurrence

Potential orolabial HSV-1 recurrence represents a subset of adverse events of special interest (AESIs).

Time frame: From Day 1 up to study end at Day 421

Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-vaccination (Day 1)

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.

Time frame: At pre-vaccination (Day 1)

Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 2

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.

Time frame: At Day 2

Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.

Time frame: At Day 8

Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.

Time frame: At Day 57

Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 58

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.

Time frame: At Day 58

Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.

Time frame: At Day 64

Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 85

Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.

Time frame: At Day 85