A Study of V118E in Healthy Participants (V118E-003) (NCT07168915) | Clinical Trial Compass
RecruitingPhase 1
A Study of V118E in Healthy Participants (V118E-003)
United States126 participantsStarted 2025-10-08
Plain-language summary
Researchers are looking for new vaccines to prevent illnesses caused by a type of bacteria called Streptococcus pneumoniae. There are many different types of Streptococcus pneumoniae bacteria, called serotypes. Vaccines contain small parts of certain serotypes. These parts will not cause an infection but help the body create antibodies (proteins) to fight the bacteria.
PREVNAR 20™ is a vaccine given to help to prevent disease from Streptococcus pneumoniae bacteria. Researchers designed a new vaccine, V118E, to help prevent disease from Streptococcus pneumoniae bacteria.
The goal of this study is to learn how safe V118 formulation E is in Healthy Adults and how well people tolerate it.
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
\- Is in good health before randomization
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination
* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Solicited Injection-Site Adverse Events (AEs)
Timeframe: Up to approximately 7 days after each vaccination
2
Number of Participants With Solicited Systemic AEs
Timeframe: Up to approximately 7 days after each vaccination
3
Number of Participants With Immediate AEs Following Vaccination
Timeframe: Up to approximately 30 minutes after each vaccination
4
Number of Participants With Unsolicited AEs
Timeframe: Up to approximately 28 days after each vaccination
5
Number of Participants With a Serious Adverse Event (SAE)
Timeframe: Up to approximately 12 months after final vaccination
6
Number of Participants With a Medically Attended Adverse Event (MAAE)
Timeframe: Up to approximately 12 months after final vaccination
7
Number of Participants With an Adverse Events of Special Interest (AESI)