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A Phase 2 Safety and Immunogenicity Study of a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers
EU CTIS ID: 2023-505154-18-00
What this study is testing
To describe the safety profile of the mPnC candidate administered as a 2-dose series in children ≥11 to ≤15 months of age.
- Therapeutic exploratory (Phase II)
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
- Toddlers ≥11 and ≤15 months of age at the time of consent.
- Have received exactly 2 infant doses of PCV10 according to a local immunization schedule.
- Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
You likely can't join if
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of study intervention, 13vPnC, 20vPnC, or any diphtheria toxoid–containing vaccine.
- Significant neurological disorder or history of seizure (excluding febrile seizure) or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders.
- Major known congenital malformation or serious chronic disorder.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- Previous vaccination with any licensed pneumococcal vaccine (other than the PCV10 primary infant series) or investigational pneumococcal vaccine, or planned receipt of nonstudy pneumococcal vaccine during study participation.
The study team makes the final eligibility decision.
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.
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.