Clinical Trials in the USA / NCT07300267
Recruiting
Phase 1
A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)
NCT07300267 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Pneumococcal Infection
Investigational drug(s) / intervention(s)
V118C (Stage 1): IM administration of V118C
V118C (Stage 2): IM administration of V118C
PCV20 (Stage 1): IM administration of PCV20
PCV20 (Stage 2): IM administration of PCV20
Study 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.
Eligibility
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
Primary outcome measure(s)
- Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination — Up to approximately 30 minutes postvaccination
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. - Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) — Up to approximately 7 days postvaccination
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. - Stage 1: Percentage of Participants With Solicited Systemic AEs — Up to approximately 7 days postvaccination
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. - Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs — Up to approximately 28 days postvaccination
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. - Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) — Up to approximately 12 months postvaccination
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. - Stage 1: Percentage of Participants With Medically Attended AEs (MAAEs) — Up to approximately 12 months postvaccination
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. - Stage 2: Percentage of Participants With Immediate AEs Following Vaccination — Up to approximately 30 minutes after each 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. - Stage 2: Percentage of Participants With Solicited Injection-Site AEs — Up to approximately 7 days after each 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. 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. - Stage 2: Percentage of Participants With Solicited Systemic AEs — Up to approximately 7 days after each 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. 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. - Stage 2: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs — Up to approximately 28 days after each 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. 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. - Stage 2: Percentage of Participants With SAEs — Up to approximately 12 months postdose 4
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. - Stage 2: Percentage of Participants With MAAEs — Up to approximately 12 months postdose 4
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.
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| Madera Family Medical Group ( Site 1004) | Madera | California | Recruiting |
| Acevedo Clinical Research Associates ( Site 1029) | Miami | Florida | Recruiting |
| University of South Florida-Department of Pediatrics ( Site 1002) | Tampa | Florida | Recruiting |
| Cotton O'Neil Research Center ( Site 1039) | Topeka | Kansas | Recruiting |
| University of Louisville, Norton Children's Research Institute ( Site 1005) | Louisville | Kentucky | Recruiting |
| The Pediatric Center ( Site 1025) | Columbia | Maryland | Recruiting |
| Saint Louis University Center for Vaccine Development ( Site 1031) | St Louis | Missouri | Recruiting |
| Child Health Care Associates ( Site 1035) | East Syracuse | New York | Recruiting |
| Carolina Family Care ( Site 1021) | Charleston | South Carolina | Recruiting |
| Tribe Clinical Research, LLC-Pediatrics ( Site 1008) | Greenville | South Carolina | Recruiting |
| Tribe Clinical Research - Spartanburg ( Site 1001) | Spartanburg | South Carolina | Recruiting |
| Epic Medical Research - Carrollton ( Site 1038) | Carrollton | Texas | Recruiting |
| Epic Medical Research- Garland ( Site 1017) | Garland | Texas | Recruiting |
| University of Texas Medical Branch ( Site 1020) | League City | Texas | Recruiting |
| Pediatric Research of Charlottesville, LLC ( Site 1012) | Charlottesville | Virginia | Recruiting |
More Merck Sharp & Dohme LLC trials in the USA
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07300267 on ClinicalTrials.gov ↗ ← All trials in the USA