Study of V118E for Pneumococcal Disease Prevention
This study is testing a new vaccine called V118E. Researchers want to see how safe V118E is and how well people tolerate it, compared to PREVNAR 20™ (another vaccine for pneumococcal disease) and saline (a saltwater solution). These vaccines help your body create antibodies (proteins that fight infection) against Streptococcus pneumoniae bacteria, which can cause illnesses. We are looking for healthy adults between 18 and 49 years old to join. The main goal is to track any side effects at the injection site, throughout the body, and immediately after vaccination. The study is currently recruiting 126 participants.
- Study design
- This interventional study plans to enroll 126 healthy participants. It compares the safety and tolerability of V118E, PREVNAR 20™, and saline.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for injection-site and systemic side effects for up to about 7 days after each vaccination, and for immediate side effects for up to about 30 minutes after each vaccination.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of V118E in Healthy Participants (V118E-003)
At a glance
Conditions
Where it's being run
4 sites across 3 statesStudy leadership
- Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Exclusion
What this trial measures
- Number of Participants With Solicited Injection-Site Adverse Events (AEs)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, which occurs during the course of the study. A solicited AE is a predefined event that participants are specifically asked about and record on their vaccine report card (VRC). Solicited injection-site AEs include redness, swelling, and pain or tenderness. The number of participants with a solicited injection-site AE will be reported.
- Number of Participants With Solicited Systemic AEsUp 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, which occurs during the course of the study. A solicited AE is a predefined event that participants are specifically asked about and record on their VRC. Solicited systemic AEs include fever, muscle aches all over body, joint pain, headache, and tiredness. The number of participants with a solicited systemic AE will be reported.
- Number of Participants With Immediate AEs Following VaccinationUp 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, which occurs during the course of the study. The number of participants with immediate AEs following vaccination will be reported.
- Number of Participants With Unsolicited AEsUp 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, which occurs during the course of the study. An unsolicited AE is an event that is not solicited using a VRC and that is communicated by a participant. The number of participants who experience an unsolicited AE will be reported.
- Number of Participants With a Serious Adverse Event (SAE)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)Up to approximately 12 months after final vaccination
A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. The number of participants who experience a MAAE will be reported.
- Number of Participants With an Adverse Events of Special Interest (AESI)Up to approximately 12 months after final vaccination
AESIs are selected serious and nonserious AEs which include but are not limited to: 1) Potential drug-induced liver injury (DILI) events defined as an elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory value that is ≥3\* the upper limit of normal (ULN) and an elevated total bilirubin laboratory value that is ≥2\* the ULN and, at the same time, an alkaline phosphatase laboratory value that is \<2\* the ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. 2) an overdose of V118E. 3) Potential immune-mediated disease (pIMDs) defined as a subset of AEs that an established autoimmune disease(s) AND inflammatory and/or neurologic disorder(s), which might or might not have an autoimmune etiology. The number of participants who experience an AESI will be reported.