A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)
ConditionPneumococcal Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-15
SponsorMerck Sharp & Dohme LLC
About this trial
Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae. V118C is a new vaccine designed to help prevent disease from Streptococcus pneumoniae bacteria.
This study will look at V118C in toddlers and infants. The goal of the study is to learn how safe V118C is for children and how well they tolerate it.
Eligibility criteria
Qualifiers
Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20)
Is 12 through 15 months of age
Was born at full term (gestational age greater than or equal to 37 weeks)
Disqualifiers
Has received prior administration of any pneumococcal vaccine
Has a history of invasive pneumococcal disease (IPD)
Has a known hypersensitivity to any component of V118C or PCV20 including diphtheria toxoid
Trial design
Treatments tested in this trial
- V118C (Stage 1)
- V118C (Stage 2)
- PCV20 (Stage 1)
- PCV20 (Stage 2)
Treatment groups
210 Participants
are divided into 4 treatment groupsLocations
14California
Madera Family Medical Group ( Site 1004)93637, Madera United States
Florida
Acevedo Clinical Research Associates ( Site 1029)33142, Miami United States
University of South Florida-Department of Pediatrics ( Site 1002)33606, Tampa United States
Kansas
Cotton O'Neil Research Center ( Site 1039)66604, Topeka United States
Sponsors and collaborators
Merck Sharp & Dohme LLC
Lead sponsor
Source ClinicalTrials.gov