RecruitingPhase 1

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

United States210 participantsStarted 2026-01-13

Plain-language 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.

Who can participate

Age range2 Months – 15 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination

Timeframe: Up to approximately 30 minutes postvaccination

Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)

Timeframe: Up to approximately 7 days postvaccination

Stage 1: Percentage of Participants With Solicited Systemic AEs

Timeframe: Up to approximately 7 days postvaccination

Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs

Timeframe: Up to approximately 28 days postvaccination

Stage 1: Percentage of Participants With Serious Adverse Events (SAEs)

Timeframe: Up to approximately 12 months postvaccination

Stage 1: Percentage of Participants With Medically Attended AEs (MAAEs)

Timeframe: Up to approximately 12 months postvaccination

Stage 2: Percentage of Participants With Immediate AEs Following Vaccination

Timeframe: Up to approximately 30 minutes after each vaccination

Trial details

NCT IDNCT07300267

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10-24

Contact for this trial

Toll Free Number

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

View on ClinicalTrials.gov More Pneumococcal Infection trials

Plain-language summary

Who can participate

Age range2 Months – 15 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination

Timeframe: Up to approximately 30 minutes postvaccination

Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)

Timeframe: Up to approximately 7 days postvaccination

Stage 1: Percentage of Participants With Solicited Systemic AEs

Timeframe: Up to approximately 7 days postvaccination

Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs

Timeframe: Up to approximately 28 days postvaccination

Stage 1: Percentage of Participants With Serious Adverse Events (SAEs)

Timeframe: Up to approximately 12 months postvaccination

Stage 1: Percentage of Participants With Medically Attended AEs (MAAEs)

Timeframe: Up to approximately 12 months postvaccination

Stage 2: Percentage of Participants With Immediate AEs Following Vaccination

Timeframe: Up to approximately 30 minutes after each vaccination