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V118C pneumococcal vaccine in infants and toddlers

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

Phase 1 Interventional Merck Sharp & Dohme LLC · NCT07300267

This will try a new pneumococcal vaccine called V118C in infants and toddlers to check safety and how well they tolerate it.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment210 (estimated)
Ages2 Months to 15 Months
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations14 sites (Madera, California and 13 other locations)
Trial IDNCT07300267 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy full‑term infants around 2 months old for the infant schedule or healthy full‑term toddlers 12–15 months old who have completed a 3‑dose PCV20 infant series.

Not a fit: Children with a history of invasive pneumococcal disease, known hypersensitivity to vaccine components, premature birth before 37 weeks, or prior disallowed pneumococcal vaccination would be excluded and therefore would not receive potential benefit from this study.

Why it matters

Potential benefit: If successful, V118C could become an additional pneumococcal vaccine option that may offer broader or improved protection for young children.

How similar studies have performed: Licensed pneumococcal conjugate vaccines such as PCV13 and PCV20 have previously reduced pneumococcal disease in children, but V118C is a novel formulation being tested for safety in this early‑phase trial.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Madera, California and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pneumococcal Infection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.