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

NCT07300267 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: V118C-002
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Pneumococcal Infection

Outcome Measures

Primary Outcomes (12)

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

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.

  Up to approximately 30 minutes postvaccination

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

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants legally acceptable representative (LAR) are specifically asked about and record on their electronic vaccine report card (eVRC). Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.

  Up to approximately 7 days postvaccination

• Stage 1: Percentage of Participants With Solicited Systemic AEs

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be reported.

  Up to approximately 7 days postvaccination

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

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.

  Up to approximately 28 days postvaccination

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

  A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.

  Up to approximately 12 months postvaccination

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

  A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.

  Up to approximately 12 months postvaccination

• Stage 2: Percentage of Participants With Immediate AEs Following Vaccination

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.

  Up to approximately 30 minutes after each vaccination

• Stage 2: Percentage of Participants With Solicited Injection-Site AEs

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.

  Up to approximately 7 days after each vaccination

• Stage 2: Percentage of Participants With Solicited Systemic AEs

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be recorded.

  Up to approximately 7 days after each vaccination

• Stage 2: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.

  Up to approximately 28 days after each vaccination

• Stage 2: Percentage of Participants With SAEs

  A SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.

  Up to approximately 12 months postdose 4

• Stage 2: Percentage of Participants With MAAEs

  A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.

  Up to approximately 12 months postdose 4

Secondary Outcomes (14)

• Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)

  Up to approximately 30 days post vaccination

• Stage 1: Ratio of GMCs of Serotype-Specific IgG of V118C to PCV20 [V118C/PCV20]

  Approximately Day 30 postvaccination

• Stage 1: Geometric Mean Fold Rises (GMFRs) of Serotype-Specific Immunoglobulin G (IgG)

  Day 1 (Baseline) and approximately Day 30 postvaccination

• Stage 1: Percentage of Participants With a ≥ 4-fold Rise for Serotype Specific IgG Concentrations

  Day 1 (Baseline) and approximately Day 30 postvaccination

• Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 3

  Up to approximately 30 days postdose 3

Study Arms (4)

V118C (Stage 1)

EXPERIMENTAL

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

Biological: V118C (Stage 1)

V118C (Stage 2)

EXPERIMENTAL

Participants will receive a single 0.5 mL IM injection of V118C administered at 2,4,6, and 12 months of age.

Biological: V118C (Stage 2)

PCV20 (Stage 1)

ACTIVE COMPARATOR

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

Biological: PCV20 (Stage 1)

PCV20 (Stage 2)

ACTIVE COMPARATOR

Participants will receive a single 0.5 mL IM injection of PCV20 administered at 2,4,6, and 12 months of age.

Biological: PCV20 (Stage 2)

Interventions

PCV20 (Stage 1) BIOLOGICAL

IM administration of PCV20

PCV20 (Stage 1)

V118C (Stage 1) BIOLOGICAL

IM administration of V118C

V118C (Stage 1)

V118C (Stage 2) BIOLOGICAL

IM administration of V118C

V118C (Stage 2)

PCV20 (Stage 2) BIOLOGICAL

IM administration of PCV20

PCV20 (Stage 2)

Eligibility Criteria

• Age: 2 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (14)

Madera Family Medical Group ( Site 1004)

Madera, California, 93637, United States

RECRUITING

Acevedo Clinical Research Associates ( Site 1029)

Miami, Florida, 33142, United States

RECRUITING

University of South Florida-Department of Pediatrics ( Site 1002)

Tampa, Florida, 33606, United States

RECRUITING

Cotton O'Neil Research Center ( Site 1039)

Topeka, Kansas, 66604, United States

RECRUITING

University of Louisville, Norton Children's Research Institute ( Site 1005)

Louisville, Kentucky, 40202, United States

RECRUITING

The Pediatric Center ( Site 1025)

Columbia, Maryland, 21045, United States

RECRUITING

Saint Louis University Center for Vaccine Development ( Site 1031)

St Louis, Missouri, 63104, United States

RECRUITING

Child Health Care Associates ( Site 1035)

East Syracuse, New York, 13057, United States

RECRUITING

Tribe Clinical Research, LLC-Pediatrics ( Site 1008)

Greenville, South Carolina, 29607, United States

RECRUITING

Tribe Clinical Research - Spartanburg ( Site 1001)

Spartanburg, South Carolina, 29301, United States

RECRUITING

Epic Medical Research - Carrollton ( Site 1038)

Carrollton, Texas, 75006, United States

RECRUITING

Epic Medical Research- Garland ( Site 1017)

Garland, Texas, 75043, United States

RECRUITING

University of Texas Medical Branch ( Site 1020)

League City, Texas, 77573, United States

RECRUITING

Pediatric Research of Charlottesville, LLC ( Site 1012)

Charlottesville, Virginia, 22902, United States

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): October 24, 2028
• Study Completion (Estimated): May 25, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (14)