A Phase 1, Randomized, Double-Blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Novel Pneumococcal Vaccine in Children
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 1
Healthy Volunteers: t
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⁃ The main inclusion criteria include but are not limited to the following:
⁃ Stage 1:
• Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20)
• Is 12 through 15 months of age
⁃ Stage 2:
⁃ \- Is approximately 2 months of age
⁃ Both Stages:
• Was born at full term (gestational age greater than or equal to 37 weeks)
Locations
United States
California
Madera Family Medical Group ( Site 1004)
RECRUITING
Madera
Kansas
Cotton O'Neil Research Center ( Site 1039)
RECRUITING
Topeka
Kentucky
University of Louisville, Norton Children's Research Institute ( Site 1005)
RECRUITING
Louisville
South Carolina
Tribe Clinical Research, LLC-Pediatrics ( Site 1008)
RECRUITING
Greenville
Tribe Clinical Research, LLC-Pediatrics ( Site 1001)
RECRUITING
Spartanburg
Texas
Epic Medical Research - Carrollton ( Site 1038)
RECRUITING
Carrollton
University of Texas Medical Branch ( Site 1020)
RECRUITING
League City
Virginia
Pediatric Research of Charlottesville, LLC ( Site 1012)
RECRUITING
Charlottesville
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date:2026-01-13
Estimated Completion Date:2029-05-25
Participants
Target number of participants:210
Treatments
Experimental: V118C (Stage 1)
Participants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age.
Experimental: V118C (Stage 2)
Participants will receive a single 0.5 mL IM injection of V118C administered at 2,4,6, and 12 months of age.
Active_comparator: PCV20 (Stage 1)
Participants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age.
Active_comparator: PCV20 (Stage 2)
Participants will receive a single 0.5 mL IM injection of PCV20 administered at 2,4,6, and 12 months of age.