210 Participants Needed

V118C Vaccine for Pneumococcal Infections

Recruiting at 7 trial locations
TF
Overseen ByToll Free Number
Age: < 18
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Pneumococcal vaccine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, V118C, to determine if it can safely prevent infections caused by Streptococcus pneumoniae in young children. Researchers aim to assess how well children tolerate the vaccine and compare it to the existing vaccine, PCV20. The trial seeks full-term toddlers who have already received routine doses of the PCV20 vaccine and infants around 2 months old who have not had any pneumococcal vaccines. This study holds importance for parents interested in protecting their children from serious bacterial infections. As a Phase 1 trial, the research focuses on understanding how the new vaccine works in people, offering participants the unique opportunity to be among the first to receive this potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the V118C vaccine is undergoing tests to prevent infections caused by *Streptococcus pneumoniae*. An earlier study with healthy adults found the vaccine to be generally well-tolerated, with most side effects being mild and temporary, such as soreness at the injection site or a mild fever.

Data on current pneumococcal vaccines indicates that most side effects are not serious. For instance, a large review found that over 80% of side effects were mild, like swelling or redness at the injection site. Serious side effects were much less common.

As the V118C vaccine is still in the early stages of testing with children, its safety profile is still being established. However, information from adult trials and existing vaccines suggests it may be safe.12345

Why do researchers think this study treatment might be promising?

V118C is unique because it offers a new approach to preventing pneumococcal infections in young children. Unlike current vaccines like PCV13 and PCV20, which have been the standard options, V118C is designed to be administered at both earlier and more frequent intervals, potentially providing broader and more robust immunity. Researchers are particularly excited about V118C's potential to cover additional pneumococcal strains, which could enhance protection and reduce the incidence of these infections in a vulnerable age group.

What evidence suggests that this trial's treatments could be effective for preventing pneumococcal infections?

This trial will compare the V118C vaccine with the PCV20 vaccine. Research has shown that the V118C vaccine is designed to protect against infections caused by Streptococcus pneumoniae bacteria. Early studies found that similar vaccines can trigger strong immune responses, helping the body fight the bacteria more effectively. Although data on V118C remains limited, the vaccine aims to provide effective protection. The goal is to help prevent serious illnesses caused by this bacteria, especially in young children.12678

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for toddlers and infants who are about 2 months old, born at full term (37 weeks or more), and have already received 3 doses of the PCV20 vaccine. They should be between 12 to 15 months old to participate.

Inclusion Criteria

I received 3 doses of the PCV20 vaccine as an infant.
I am between 12 and 15 months old.
My child is about 2 months old.
See 1 more

Exclusion Criteria

I received a PCV vaccine dose when I was 10 months old or older.
I have received a pneumococcal vaccine before.
I have had a serious lung infection before.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (Stage 1)

Participants receive a single 0.5 mL IM injection of V118C or PCV20 at 12 to 15 months of age

1 day
1 visit (in-person)

Treatment (Stage 2)

Participants receive a single 0.5 mL IM injection of V118C or PCV20 at 2, 4, 6, and 12 months of age

10 months
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • V118C

Trial Overview

The study is testing a new pneumococcal vaccine called V118C in children. It aims to determine the safety and tolerance of this vaccine compared to PCV20, which is an existing pneumococcal vaccine.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: V118C (Stage 2)Experimental Treatment1 Intervention
Group II: V118C (Stage 1)Experimental Treatment1 Intervention
Group III: PCV20 (Stage 1)Active Control1 Intervention
Group IV: PCV20 (Stage 2)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

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Pneumococcal Vaccine Safety

You can protect against serious pneumococcal infections with vaccination. ... A closer look at the safety data. A 2004 study of VAERS data ...

Post-marketing safety surveillance of pneumococcal vaccines

According to VAERS data, 81.84% of AEs following pneumococcal vaccination were classified as non-serious, while 18.16% constituted serious AEs.

Pneumococcal

PPSV23 is 60-70% effective against invasive pneumococcal disease caused by vaccine serotypes, although ineffective in children younger than 2 years of age.