En klinisk studie av den nye pneumokokkvaksinen V118C hos barn (V118C-002)
En fase 1, randomisert, dobbeltblind, aktiv komparatorkontrollert studie for å evaluere sikkerhet, tolerabilitet og immunogeniteten til en ny pneumokokkvaksine hos barn
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studiesteder
-
-
California
-
Madera, California, Forente stater, 93637
- Rekruttering
- Madera Family Medical Group ( Site 1004)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 559-673-3000
-
-
Florida
-
Miami, Florida, Forente stater, 33142
- Rekruttering
- Acevedo Clinical Research Associates ( Site 1029)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 305-649-8871
-
Tampa, Florida, Forente stater, 33606
- Rekruttering
- University of South Florida-Department of Pediatrics ( Site 1002)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 813-821-8039
-
-
Kansas
-
Topeka, Kansas, Forente stater, 66604
- Rekruttering
- Cotton O'Neil Research Center ( Site 1039)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 785-354-6000
-
-
Kentucky
-
Louisville, Kentucky, Forente stater, 40202
- Rekruttering
- University of Louisville, Norton Children's Research Institute ( Site 1005)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 502-629-5820
-
-
Maryland
-
Columbia, Maryland, Forente stater, 21045
- Rekruttering
- The Pediatric Center ( Site 1025)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 443-721-7224
-
-
Missouri
-
St Louis, Missouri, Forente stater, 63104
- Rekruttering
- Saint Louis University Center for Vaccine Development ( Site 1031)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 314-977-6333
-
-
New York
-
East Syracuse, New York, Forente stater, 13057
- Rekruttering
- Child Health Care Associates ( Site 1035)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 315-652-8800
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29414
- Rekruttering
- Carolina Family Care ( Site 1021)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 843-870-2225
-
Greenville, South Carolina, Forente stater, 29607
- Rekruttering
- Tribe Clinical Research, LLC-Pediatrics ( Site 1008)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 864-334-0141
-
Spartanburg, South Carolina, Forente stater, 29301
- Rekruttering
- Tribe Clinical Research - Spartanburg ( Site 1001)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 864-334-0141
-
-
Texas
-
Carrollton, Texas, Forente stater, 75006
- Rekruttering
- Epic Medical Research - Carrollton ( Site 1038)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 972-777-6956
-
Garland, Texas, Forente stater, 75043
- Rekruttering
- Epic Medical Research- Garland ( Site 1017)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 972-777-6956
-
League City, Texas, Forente stater, 77573
- Rekruttering
- University of Texas Medical Branch ( Site 1020)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 832-340-2313
-
-
Virginia
-
Charlottesville, Virginia, Forente stater, 22902
- Rekruttering
- Pediatric Research of Charlottesville, LLC ( Site 1012)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 434-872-9384
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: V118C (Stage 1)
Participants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age. |
IM administration of V118C |
|
Eksperimentell: V118C (Stage 2)
Participants will receive a single 0.5 mL IM injection of V118C administered at 2,4,6, and 12 months of age. |
IM administration of V118C |
|
Aktiv komparator: PCV20 (Stage 1)
Participants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age. |
IM administration of PCV20 |
|
Aktiv komparator: PCV20 (Stage 2)
Participants will receive a single 0.5 mL IM injection of PCV20 administered at 2,4,6, and 12 months of age. |
IM administration of PCV20 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination
Tidsramme: 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. |
Up to approximately 30 minutes postvaccination
|
|
Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
Tidsramme: 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. |
Up to approximately 7 days postvaccination
|
|
Stage 1: Percentage of Participants With Solicited Systemic AEs
Tidsramme: 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. |
Up to approximately 7 days postvaccination
|
|
Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
Tidsramme: 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. |
Up to approximately 28 days postvaccination
|
|
Stage 1: Percentage of Participants With Serious Adverse Events (SAEs)
Tidsramme: 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. |
Up to approximately 12 months postvaccination
|
|
Stage 1: Percentage of Participants With Medically Attended AEs (MAAEs)
Tidsramme: 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. |
Up to approximately 12 months postvaccination
|
|
Stage 2: Percentage of Participants With Immediate AEs Following Vaccination
Tidsramme: 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. |
Up to approximately 30 minutes after each vaccination
|
|
Stage 2: Percentage of Participants With Solicited Injection-Site AEs
Tidsramme: 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. |
Up to approximately 7 days after each vaccination
|
|
Stage 2: Percentage of Participants With Solicited Systemic AEs
Tidsramme: 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. |
Up to approximately 7 days after each vaccination
|
|
Stage 2: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
Tidsramme: 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. |
Up to approximately 28 days after each vaccination
|
|
Stage 2: Percentage of Participants With SAEs
Tidsramme: 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. |
Up to approximately 12 months postdose 4
|
|
Stage 2: Percentage of Participants With MAAEs
Tidsramme: 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. |
Up to approximately 12 months postdose 4
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)
Tidsramme: Up to approximately 30 days post vaccination
|
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
|
|
Stage 1: Ratio of GMCs of Serotype-Specific IgG of V118C to PCV20 [V118C/PCV20]
Tidsramme: Approximately Day 30 postvaccination
|
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)
Tidsramme: Day 1 (Baseline) and approximately Day 30 postvaccination
|
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
Tidsramme: Day 1 (Baseline) and approximately Day 30 postvaccination
|
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
Tidsramme: Up to approximately 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
Tidsramme: Up to approximately 6 months post dose 3
|
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
Tidsramme: Up to approximately 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
Tidsramme: Up to approximately 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
Tidsramme: Up to approximately 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
Tidsramme: Up to approximately 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
Tidsramme: Up to approximately 6 months post dose 3
|
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
Tidsramme: Up to approximately 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
Tidsramme: Up to approximately 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
Tidsramme: Up to approximately 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- V118C-002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .