Study

Overview

Official Title: A Phase 1, Randomized, Double-Blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Novel Pneumococcal Vaccine in Children

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.

Study Type:

Interventional

Study Phase:

Phase 1

Estimated Enrollment:

210

Study Start Date:

January 2026

Estimated Study Completion Date:

May 2029

Estimated Primary Completion Date:

October 2028

Eligibility

Ages Eligible for Study:

2 months to 15 months

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

CRITERIA

Inclusion Criteria:

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)

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Stage 1:

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

Locations

United States Toll Free Number 1-800-770-4674

Madera, California, 93637
Topeka, Kansas, 66604
Louisville, Kentucky, 40202
Greenville, South Carolina, 29607
Spartanburg, South Carolina, 29301
Carrollton, Texas, 75006
League City, Texas, 77573
Charlottesville, Virginia, 22902

Results

No Study Results Posted

Study Detail

A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)

Overview

Eligibility

CRITERIA

Locations

Results