BridgeMD
Safety and Immunogenicity of V116 in Children and Adolescents With Increased Risk for Pneumococcal Disease
EU CTIS ID: 2023-506236-32-00
What this study is testing
1. To evaluate the safety and tolerability of V116 with respect to the proportion of participants with adverse events (AEs) 2. To compare the serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs) at 30 days postvaccination with V116 versus PPSV23.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has one or more of the following risk conditions for pneumococcal disease: • Diabetes mellitus receiving treatment with antidiabetic medication • Chronic compensated liver disease • Chronic lung disease • Chronic heart disease • Chronic kidney disease, with chronic kidney insufficiency/impairment
- Receiving stable medical management for the risk conditions listed above for ≥3 months.
- Has not received pneumococcal vaccine, polyvalent (23-valent) (PPSV23) or has received not more than 1 dose of PPSV23 ≥5 years before study vaccination.
You likely can't join if
- Had a curative procedure/surgery for chronic heart disease and does not require medication, follow-up, additional interventions, or further management per local guidelines.
- History of active hepatitis within 3 months before study vaccination
- History of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before study vaccination
- History of severely decreased kidney function
- History of severe pulmonary hypertension
- History of invasive pneumococcal disease (IPD) or known history of other culture-positive pneumococcal disease within 3 years before study vaccination
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- Chile
- Canada
- Colombia
- Japan
- Turkey
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; Chile; Canada; Colombia; Japan; Turkey and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.