MedDataX Logo

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

NCT ID: NCT07300267

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-21

Study Completion Date

2029-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumococcal Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

PCV20 (Stage 2)

Intervention Type BIOLOGICAL

IM administration of PCV20

V118C (Stage 1)

Participants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age.

Group Type EXPERIMENTAL

V118C (Stage 1)

Intervention Type BIOLOGICAL

IM administration of V118C

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.

Group Type EXPERIMENTAL

V118C (Stage 2)

Intervention Type BIOLOGICAL

IM administration of V118C

PCV20 (Stage 1)

Participants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age.

Group Type ACTIVE_COMPARATOR

PCV20 (Stage 1)

Intervention Type BIOLOGICAL

IM administration of PCV20

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

V118C (Stage 1)

IM administration of V118C

Intervention Type BIOLOGICAL

V118C (Stage 2)

IM administration of V118C

Intervention Type BIOLOGICAL

PCV20 (Stage 1)

IM administration of PCV20

Intervention Type BIOLOGICAL

PCV20 (Stage 2)

IM administration of PCV20

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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
Minimum Eligible Age

2 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Related Links

Access external resources that provide additional context or updates about the study.

https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

V118C-002

Identifier Type: -

Identifier Source: org_study_id