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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 2 Months and 15 Months
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Biological: V118C (Stage 1)
    IM administration of V118C
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.
  • Biological: V118C (Stage 2)
    IM administration of V118C
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.
  • Biological: PCV20 (Stage 1)
    IM administration of PCV20
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.
  • Biological: PCV20 (Stage 2)
    IM administration of PCV20

Recruiting Locations

University of Texas Medical Branch ( Site 1020)
League City 4705692, Texas 4736286 77573
Contact:
Study Coordinator
832-340-2313

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Detailed Description

Stage 1 of the study will be conducted in toddlers enrolled at 12 through 15 months of age who previously completed a primary 3-dose infant series with a licensed pneumococcal conjugate vaccine (PCV). Stage 2 will be conducted in infants enrolled at approximately 2 months of age, who will receive the 3+1 schedule (3 infant doses followed by a toddler dose).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.