A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)
NCT ID: NCT07300267
Last Updated: 2026-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
210 participants
INTERVENTIONAL
2026-01-13
2029-05-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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V118C (Stage 1)
Participants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age.
V118C (Stage 1)
IM administration of V118C
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.
V118C (Stage 2)
IM administration of V118C
PCV20 (Stage 1)
Participants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age.
PCV20 (Stage 1)
IM administration of PCV20
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.
PCV20 (Stage 2)
IM administration of PCV20
Interventions
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V118C (Stage 1)
IM administration of V118C
V118C (Stage 2)
IM administration of V118C
PCV20 (Stage 1)
IM administration of PCV20
PCV20 (Stage 2)
IM administration of PCV20
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
\- Has received a PCV dose at 10 months of age and older
Stage 2:
* Has received prior administration of any pneumococcal vaccine
Both stages:
* Has a history of invasive pneumococcal disease (IPD)
* Has a known hypersensitivity to any component of V118C or PCV20 including diphtheria toxoid
2 Months
15 Months
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Madera Family Medical Group ( Site 1004)
Madera, California, United States
Cotton O'Neil Research Center ( Site 1039)
Topeka, Kansas, United States
University of Louisville, Norton Children's Research Institute ( Site 1005)
Louisville, Kentucky, United States
Tribe Clinical Research, LLC-Pediatrics ( Site 1008)
Greenville, South Carolina, United States
Tribe Clinical Research, LLC-Pediatrics ( Site 1001)
Spartanburg, South Carolina, United States
Epic Medical Research - Carrollton ( Site 1038)
Carrollton, Texas, United States
University of Texas Medical Branch ( Site 1020)
League City, Texas, United States
Pediatric Research of Charlottesville, LLC ( Site 1012)
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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V118C-002
Identifier Type: -
Identifier Source: org_study_id
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