A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V118 Formulation C in Healthy Adults

Number of Participants with Solicited Injection Site Adverse Events (AEs)

时间窗: Up to approximately 7 days after each vaccination

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with a solicited injection-site AE will be reported.

Number of Participants with Solicited Systemic AEs

时间窗: Up to approximately 7 days after each vaccination

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with a solicited systemic AE will be reported.

Number of Participants with Immediate AEs Following Vaccination

时间窗: Up to approximately 30 minutes after each vaccination

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with Immediate AEs following vaccination will be reported.

Number of Participants with Unsolicited AEs

时间窗: Up to approximately 28 days after each vaccination

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. An unsolicited AE is an AE that is not solicited using a vaccine report card (VRC) and that is communicated by a participant. The number of participants that experienced an unsolicited AE will be reported.

Number of Participants With a Serious Adverse Event (SAE)

时间窗: Up to approximately 12 months after final vaccination

An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The number of participants who experience an SAE will be reported.

Number of Participants with a Medically Attended Adverse Event (MAAE)

时间窗: Up to approximately 12 months after final vaccination

An MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason. The number of participants who experience an MAAE will be reported.

Number of Participants with an Event of Clinical Interest (ECI)

时间窗: Up to approximately 12 months after final vaccination

An ECI includes but is not limited to: 1) An overdose defined as: A participant receiving more than 1 dose of study vaccine in a 24-hour period or more than 2 doses of study vaccine throughout the study. 2) Potential drug-induced liver injury (DILI) events defined as: An elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is ≥3 times the upper limit of normal (ULN) and an elevated total bilirubin lab value that is ≥2 times ULN and, at the same time, an alkaline phosphatase lab value that is \<2 times ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. 3) Potential immune-mediated disease (pIMDs) defined as: A subset of AEs that include either an established autoimmune disease(s) or Inflammatory and/or neurologic disorder(s), which might or might not have an autoimmune etiology. The number of participants who experience an ECI will be reported.