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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
210
IM administration of V118C
IM administration of V118C
IM administration of PCV20
Madera Family Medical Group ( Site 1004)
Madera, California, United States
RECRUITINGCotton O'Neil Research Center ( Site 1039)
Topeka, Kansas, United States
RECRUITINGStage 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IM administration of PCV20
University of Louisville, Norton Children's Research Institute ( Site 1005)
Louisville, Kentucky, United States
RECRUITINGTribe Clinical Research, LLC-Pediatrics ( Site 1008)
Greenville, South Carolina, United States
RECRUITINGTribe Clinical Research, LLC-Pediatrics ( Site 1001)
Spartanburg, South Carolina, United States
RECRUITINGEpic Medical Research - Carrollton ( Site 1038)
Carrollton, Texas, United States
RECRUITINGUniversity of Texas Medical Branch ( Site 1020)
League City, Texas, United States
RECRUITINGPediatric Research of Charlottesville, LLC ( Site 1012)
Charlottesville, Virginia, United States
RECRUITINGTime frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 12 months postdose 4
Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. GMCs of Serotype-specific IgG at 30 days postvaccination with V118C and PCV20 will be reported.
Time frame: Up to approximately 30 days post vaccination
Stage 1: Ratio of GMCs of Serotype-Specific IgG of V118C to PCV20 [V118C/PCV20]
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of GMCs of serotype-specific IgG of V118C to PCV20 will be reported.
Time frame: Approximately Day 30 postvaccination
Stage 1: Geometric Mean Fold Rises (GMFRs) of Serotype-Specific Immunoglobulin G (IgG)
Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. GMFRs of serotype-specific IgG from baseline (Day 1) to Day 30 with V118C and PCV20 for IgG responses will be reported.
Time frame: Day 1 (Baseline) and approximately Day 30 postvaccination
Stage 1: Percentage of Participants With a ≥ 4-fold Rise for Serotype Specific IgG Concentrations
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 with V118C and PCV20 for IgG responses will be reported.
Time frame: 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
Percentage of participants with IgG ≥0.35 μg/mL (response rates) for each serotype at 30 days postdose 3 (PD3) with V118C and PCV20 will be reported will be reported.
Time frame: Up to approximately 30 days postdose 3
Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Predose 4
Percentage of participants with IgG ≥0.35 μg/mL (response rates) for each serotype at predose 4 (PD4) with V118C and PCV20 will be reported.
Time frame: Up to approximately 6 months post dose 3
Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 4
Percentage of participants with IgG ≥0.35 μg/mL (response rates) for each serotype at 30 days postdose 4 with V118C and PCV20 will be reported.
Time frame: Up to approximately 30 days postdose 4
Stage 2: Difference in the Response Rates [V118C minus PCV20] for Each Serotype at 30 Days Postdose 3
Difference in the response rates \[V118C minus PCV20\] for each serotype at 30 days postdose 3 with V118C and PCV20 will be reported.
Time frame: Up to approximately 30 days postdose 3
Stage 2: Difference in the Response Rates [V118C Minus PCV20] for Each Serotype at 30 Days Postdose 4
Difference in the response rates \[V118C minus PCV20\] for each serotype at 30 days postdose 4 with V118C and PCV20 will be reported.
Time frame: Up to approximately 30 days postdose 4
Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 3
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. GMCs of serotype-specific IgG at 30 days postdose 3 with V118C and PCV20 will be reported.
Time frame: Up to approximately 30 days postdose 3
Stage 2: GMCs of Serotype-Specific IgG at 30 Days Predose 4
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Serotype-specific IgG GMCs at 30 days predose 4 with V118C and PCV20 will be reported.
Time frame: Up to approximately 6 months post dose 3
Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 4
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Serotype-specific IgG GMCs at 30 days postdose 4 with V118C and PCV20 will be reported.
Time frame: Up to approximately 30 days postdose 4
Stage 2: Ratio of Serotype-Specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 Days Postdose 3
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of serotype-specific IgG GMCs of V118C to PCV20 \[V118C/PCV20\] at 30 days postdose 3 will be reported.
Time frame: Up to approximately 30 days postdose 3
Stage 2: Ratio of Serotype-Specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 Days Postdose 4
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of serotype-specific IgG GMCs of V118C to PCV20 \[V118C/PCV20\] at 30 days postdose 4 will be reported.
Time frame: Up to approximately 30 days postdose 4