V118C pneumococcal vaccine in infants and toddlers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial tests the safety and tolerability of V118C, a novel pneumococcal conjugate vaccine, in young children. Stage 1 enrolls healthy full‑term toddlers 12–15 months old who previously completed a 3‑dose infant series with licensed PCV20 and will receive a toddler dose, while Stage 2 enrolls approximately 2‑month‑old infants who will follow a 3+1 schedule (three infant doses plus a toddler dose). Key exclusions include prior invasive pneumococcal disease and known hypersensitivity to vaccine components, and standard clinic visits will capture safety and tolerability data. The study is sponsored by Merck and conducted at sites in California and Florida to generate early pediatric safety data to guide further development.

Why it matters

Who can join: the full rules

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

Where it's running

• Madera Family Medical Group ( Site 1004)
  Madera, California, United States Recruiting
• Acevedo Clinical Research Associates ( Site 1029)
  Miami, Florida, United States Recruiting
• University of South Florida-Department of Pediatrics ( Site 1002)
  Tampa, Florida, United States Recruiting
• Cotton O'Neil Research Center ( Site 1039)
  Topeka, Kansas, United States Recruiting
• University of Louisville, Norton Children's Research Institute ( Site 1005)
  Louisville, Kentucky, United States Recruiting
• The Pediatric Center ( Site 1025)
  Columbia, Maryland, United States Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pneumococcal Vaccine Test for severely malnourished kids in hospital

  This study tests whether giving Pneumosil to children aged 6–59 months with severe acute malnutrition in hospital elicits a better immune response than a Typhoid vaccine, with follow-up visits over six months.

  Recruiting Phase 4 Menzies School of Health Research · Dili · NCT06817421

• Safety and immune response of three PG4 vaccine lots vs 20vPnC in adults

  This study tests three different lots of a new pneumococcal vaccine and the standard 20vPnC vaccine in adults to see if they are similarly safe and provoke a similar immune response.

  Recruiting at 37 sites Phase 3 Pfizer · Birmingham, Alabama and 36 other locations · NCT07794748

• New pneumococcal vaccine safety and immune response in children and teens

  This study tests whether a new pneumococcal vaccine is as safe and as effective as Prevnar 20 in children and adolescents who have previously received PCV.

  Recruiting at 68 sites Phase 3 Pfizer · Birmingham, Alabama and 76 other locations · NCT07660198

• New pneumococcal vaccine in infants shows safety and how it stacks up against Prevnar 20

  A new pneumococcal vaccine is being tested in healthy infants to see if it is as safe as Prevnar 20 and whether it triggers a similar or better immune response.

  Recruiting at 125 sites Phase 3 Pfizer · Bessemer, Alabama and 129 other locations · NCT07629440

• New pneumococcal vaccine for healthy infants

  A new pneumococcal vaccine is being tested in about 2-month-old healthy babies to see if it is as safe as Prevnar 20 and whether it may offer broader protection against germs that cause pneumonia, meningitis, and ear infections.

  Recruiting at 72 sites Phase 3 Pfizer · Estero, Florida and 90 other locations · NCT07573462

• Serum collection after Gamma-PN vaccination to support assay development

  This project will collect blood samples from people who receive the Gamma-PN vaccine to help develop lab tests for pneumococcal disease.

  Recruiting Phase 1 GPN Vaccines · Adelaide, South Australia · NCT07205289

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.