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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V118C (Stage 1) | Biological | IM administration of V118C |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 30 days post vaccination |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Stage 1:
Stage 2:
- Is approximately 2 months of age
Both Stages:
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:
Both stages:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madera Family Medical Group ( Site 1004) | Recruiting | Madera | California | 93637 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| V118C (Stage 2) |
| Biological |
IM administration of V118C |
|
| PCV20 (Stage 1) | Biological | IM administration of PCV20 |
|
| PCV20 (Stage 2) | Biological | IM administration of PCV20 |
|
| 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 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to approximately 30 days postdose 4 |
| Acevedo Clinical Research Associates ( Site 1029) | Recruiting | Miami | Florida | 33142 | United States |
|
| University of South Florida-Department of Pediatrics ( Site 1002) | Recruiting | Tampa | Florida | 33606 | United States |
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| Cotton O'Neil Research Center ( Site 1039) | Recruiting | Topeka | Kansas | 66604 | United States |
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| University of Louisville, Norton Children's Research Institute ( Site 1005) | Recruiting | Louisville | Kentucky | 40202 | United States |
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| The Pediatric Center ( Site 1025) | Recruiting | Columbia | Maryland | 21045 | United States |
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| Saint Louis University Center for Vaccine Development ( Site 1031) | Recruiting | St Louis | Missouri | 63104 | United States |
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| Child Health Care Associates ( Site 1035) | Recruiting | East Syracuse | New York | 13057 | United States |
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| Tribe Clinical Research, LLC-Pediatrics ( Site 1008) | Recruiting | Greenville | South Carolina | 29607 | United States |
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| Tribe Clinical Research - Spartanburg ( Site 1001) | Recruiting | Spartanburg | South Carolina | 29301 | United States |
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| Epic Medical Research - Carrollton ( Site 1038) | Recruiting | Carrollton | Texas | 75006 | United States |
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| Epic Medical Research- Garland ( Site 1017) | Recruiting | Garland | Texas | 75043 | United States |
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| University of Texas Medical Branch ( Site 1020) | Recruiting | League City | Texas | 77573 | United States |
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| Pediatric Research of Charlottesville, LLC ( Site 1012) | Recruiting | Charlottesville | Virginia | 22902 | United States |
|
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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