Recruiting
Phase 1

V118C

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07300267

Conditions

Pneumococcal Infection

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Interventions

V118C (Stage 1)

V118C (Stage 2)

PCV20 (Stage 1)

PCV20 (Stage 2)

Study Details

Brief 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.

Conditions

Pneumococcal Infection

Study ID

NCT07300267

Start date

Jan 13, 2026

Status verified date

Apr, 2026

Completion date

May 25, 2029

Anticipated

Primary completion date

Oct 24, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

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

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination [ Time Frame: Up to approximately 30 minutes postvaccination ]
  • Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) [ Time Frame: Up to approximately 7 days postvaccination ]
  • Stage 1: Percentage of Participants With Solicited Systemic AEs [ Time Frame: Up to approximately 7 days postvaccination ]
  • Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs [ Time Frame: Up to approximately 28 days postvaccination ]
  • Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 12 months postvaccination ]
  • Stage 1: Percentage of Participants With Medically Attended AEs (MAAEs) [ Time Frame: Up to approximately 12 months postvaccination ]
  • Stage 2: Percentage of Participants With Immediate AEs Following Vaccination [ Time Frame: Up to approximately 30 minutes after each vaccination ]
  • Stage 2: Percentage of Participants With Solicited Injection-Site AEs [ Time Frame: Up to approximately 7 days after each vaccination ]
  • Stage 2: Percentage of Participants With Solicited Systemic AEs [ Time Frame: Up to approximately 7 days after each vaccination ]
  • Stage 2: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs [ Time Frame: Up to approximately 28 days after each vaccination ]
  • Stage 2: Percentage of Participants With SAEs [ Time Frame: Up to approximately 12 months postdose 4 ]
  • Stage 2: Percentage of Participants With MAAEs [ Time Frame: Up to approximately 12 months postdose 4 ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Madera Family Medical Group ( Site 1004)

Recruiting

Madera, California, United States, 93637

Contacts

Study Coordinator

559-673-3000

Acevedo Clinical Research Associates ( Site 1029)

Recruiting

Miami, Florida, United States, 33142

Contacts

Study Coordinator

305-649-8871

University of South Florida-Department of Pediatrics ( Site 1002)

Recruiting

Tampa, Florida, United States, 33606

Contacts

Study Coordinator

813-821-8039

Cotton O'Neil Research Center ( Site 1039)

Recruiting

Topeka, Kansas, United States, 66604

Contacts

Study Coordinator

785-354-6000

University of Louisville, Norton Children's Research Institute ( Site 1005)

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Study Coordinator

502-629-5820

The Pediatric Center ( Site 1025)

Recruiting

Columbia, Maryland, United States, 21045

Contacts

Study Coordinator

443-721-7224

Saint Louis University Center for Vaccine Development ( Site 1031)

Recruiting

St Louis, Missouri, United States, 63104

Contacts

Study Coordinator

314-977-6333

Child Health Care Associates ( Site 1035)

Recruiting

East Syracuse, New York, United States, 13057

Contacts

Study Coordinator

315-652-8800

Tribe Clinical Research, LLC-Pediatrics ( Site 1008)

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

Study Coordinator

864-334-0141

Tribe Clinical Research - Spartanburg ( Site 1001)

Recruiting

Spartanburg, South Carolina, United States, 29301

Contacts

Study Coordinator

864-334-0141

Epic Medical Research - Carrollton ( Site 1038)

Recruiting

Carrollton, Texas, United States, 75006

Contacts

Study Coordinator

972-777-6956

Epic Medical Research- Garland ( Site 1017)

Recruiting

Garland, Texas, United States, 75043

Contacts

Study Coordinator

972-777-6956

University of Texas Medical Branch ( Site 1020)

Recruiting

League City, Texas, United States, 77573

Contacts

Study Coordinator

832-340-2313

Pediatric Research of Charlottesville, LLC ( Site 1012)

Recruiting

Charlottesville, Virginia, United States, 22902

Contacts

Study Coordinator

434-872-9384

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-04-17.