Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine (NCT06077656) | Clinical Trial Compass
CompletedPhase 2
Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine
Canada220 participantsStarted 2023-10-25
Plain-language summary
Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion Criteria:
* Healthy adults who are 18 through 49 years old on the day of randomization (Day 1).
* Participant must provide voluntary written informed consent to participate in the study.
* Participant must be able to comprehend and comply with study requirements and procedures and be willing and able to return for all scheduled follow-up visits.
* Adult female participants who are not surgically sterile must have a negative pregnancy test at screening and negative pregnancy test prior to vaccination and must agree to employ a highly effective method to avoid pregnancy through Day 57 of the study.
Exclusion Criteria:
* Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation.
* Adults who have previously been vaccinated against S. pneumoniae.
* History of microbiologically confirmed invasive disease caused by S. pneumoniae.
* History of allergic disease (including angioedema) or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines, including PEG.
* Any abnormal vital sign deemed clinically relevant by the PI.
* Acute illness at time of randomization (moderate or severe) and/or fever (body temperature of ≥ 38.0°C)
* History of any non-study vaccine administration within 14 days of study vaccine administration.
* No planned vaccines until after Day 29 (Visit 3).
* Chronic administration (defined as mor…