Uusi tutkimus uuden pneumokokkirokotteen V118C vaikutuksista lapsilla (V118C-002)
Fase 1 -tutkimus, satunnaistettu, kaksoissokkokontrolloitu, aktiivista vertailuryhmää käyttävä tutkimus, jossa arvioidaan uuden pneumokokkirokotteen turvallisuutta, siedettävyyttä ja immunogeenisuutta lapsilla
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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).
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Toll Free Number
- Puhelinnumero: 1-888-577-8839
- Sähköposti: Trialsites@msd.com
Opiskelupaikat
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California
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Madera, California, Yhdysvallat, 93637
- Rekrytointi
- Madera Family Medical Group ( Site 1004)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 559-673-3000
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Florida
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Miami, Florida, Yhdysvallat, 33142
- Rekrytointi
- Acevedo Clinical Research Associates ( Site 1029)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 305-649-8871
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Tampa, Florida, Yhdysvallat, 33606
- Rekrytointi
- University of South Florida-Department of Pediatrics ( Site 1002)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 813-821-8039
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Kansas
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Topeka, Kansas, Yhdysvallat, 66604
- Rekrytointi
- Cotton O'Neil Research Center ( Site 1039)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 785-354-6000
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Kentucky
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Louisville, Kentucky, Yhdysvallat, 40202
- Rekrytointi
- University of Louisville, Norton Children's Research Institute ( Site 1005)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 502-629-5820
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Maryland
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Columbia, Maryland, Yhdysvallat, 21045
- Rekrytointi
- The Pediatric Center ( Site 1025)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 443-721-7224
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Missouri
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St Louis, Missouri, Yhdysvallat, 63104
- Rekrytointi
- Saint Louis University Center for Vaccine Development ( Site 1031)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 314-977-6333
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New York
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East Syracuse, New York, Yhdysvallat, 13057
- Rekrytointi
- Child Health Care Associates ( Site 1035)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 315-652-8800
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South Carolina
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Charleston, South Carolina, Yhdysvallat, 29414
- Rekrytointi
- Carolina Family Care ( Site 1021)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 843-870-2225
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Greenville, South Carolina, Yhdysvallat, 29607
- Rekrytointi
- Tribe Clinical Research, LLC-Pediatrics ( Site 1008)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 864-334-0141
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Spartanburg, South Carolina, Yhdysvallat, 29301
- Rekrytointi
- Tribe Clinical Research - Spartanburg ( Site 1001)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 864-334-0141
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Texas
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Carrollton, Texas, Yhdysvallat, 75006
- Rekrytointi
- Epic Medical Research - Carrollton ( Site 1038)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 972-777-6956
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Garland, Texas, Yhdysvallat, 75043
- Rekrytointi
- Epic Medical Research- Garland ( Site 1017)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 972-777-6956
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League City, Texas, Yhdysvallat, 77573
- Rekrytointi
- University of Texas Medical Branch ( Site 1020)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 832-340-2313
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Virginia
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Charlottesville, Virginia, Yhdysvallat, 22902
- Rekrytointi
- Pediatric Research of Charlottesville, LLC ( Site 1012)
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Ottaa yhteyttä:
- Study Coordinator
- Puhelinnumero: 434-872-9384
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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 |
|
Kokeellinen: 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 |
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Active Comparator: 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 |
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Active Comparator: 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 |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination
Aikaikkuna: 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
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Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
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Stage 1: Percentage of Participants With Serious Adverse Events (SAEs)
Aikaikkuna: Up to approximately 12 months postvaccination
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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)
Aikaikkuna: 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
|
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Stage 2: Percentage of Participants With Immediate AEs Following Vaccination
Aikaikkuna: 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
|
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Stage 2: Percentage of Participants With Solicited Injection-Site AEs
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
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Stage 2: Percentage of Participants With SAEs
Aikaikkuna: 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
|
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Stage 2: Percentage of Participants With MAAEs
Aikaikkuna: Up to approximately 12 months postdose 4
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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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)
Aikaikkuna: 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
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Stage 1: Ratio of GMCs of Serotype-Specific IgG of V118C to PCV20 [V118C/PCV20]
Aikaikkuna: 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
|
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Stage 1: Geometric Mean Fold Rises (GMFRs) of Serotype-Specific Immunoglobulin G (IgG)
Aikaikkuna: 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
|
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Stage 1: Percentage of Participants With a ≥ 4-fold Rise for Serotype Specific IgG Concentrations
Aikaikkuna: Day 1 (Baseline) and approximately Day 30 postvaccination
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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
|
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Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 3
Aikaikkuna: 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
|
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Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Predose 4
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Medical Director, Merck Sharp & Dohme LLC
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- V118C-002
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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