Et forsøg til evaluering af effekten af CD388 på immunogeniteten af Fluzone® HD-vaccinen
En fase 1, dobbeltblind, randomiseret undersøgelse til vurdering af sikkerhed og immunogenicitet af Fluzone® High-Dose influenza-vaccine, når den administreres samtidig med CD388, et nyt langtidsvirkende antiviral konjugat til forebyggelse af influenza
Approximately one billion cases of seasonal influenza occur annually. Of these, 3 to 5 million illnesses are severe and responsible for up to 650,000 deaths per year (WHO 2025). Yearly administration of an influenza vaccine for the prevention of influenza is currently recommended. However, the real-world vaccine effectiveness varied from 10% to 60% in the general population across the years of 2004 to 2024, with effectiveness in most years below 50% (CDC 2025) and decreasing to as low as 5% in immunocompromised individuals (Hughes 2021). Researchers are looking for other ways to prevent severe illness from the influenza virus.
The goals of this study are to learn if:
- MK-1406 (formerly CD388) is safe to take with Fluzone®
- MK-1406 affects the immune response to Fluzone®
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This is a Phase 1, double-blind, randomized trial to evaluate the immunogenicity of Fluzone® HD influenza vaccine when concomitantly administered with either MK-1406 or placebo, in healthy participants. This study will also evaluate the safety and tolerability of MK-1406 when administered with Fluzone® High-Dose (HD) compared to Fluzone® HD with placebo.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-mail: Trialsites@msd.com
Studiesteder
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California
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Glendale, California, Forenede Stater, 91206
- Rekruttering
- Parexel ( Site 0001)
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Kontakt:
- Study Coordinator
- Telefonnummer: 888-228-7425
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Maryland
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Baltimore, Maryland, Forenede Stater, 21225
- Rekruttering
- Parexel ( Site 0002)
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Kontakt:
- Study Coordinator
- Telefonnummer: 410-350-3200
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Be ≥18 to ≤49 years of age
- Be deemed healthy by the Investigator
- Have not received any seasonal influenza vaccine and have not had a diagnosed or suspected influenza infection within 12 months prior to Day 1 of the trial
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Had an active malignancy within 5 years prior to screening, except basal cell or squamous cell skin cancer. Any history of breast cancer or melanoma is exclusionary.
- Has previously been diagnosed with Guillain-Barre Syndrome following a previous influenza vaccination.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Fluzone® High-Dose (HD) plus MK-1406
Participants will receive open-label Fluzone® HD influenza vaccine by intramuscular (IM) injection plus MK-1406 by subcutaneous (SC) injection on Day 1. |
Fluzone® HD injectable suspension administered by intramuscular (IM) injection
Andre navne:
MK-1406 liquid for injection administered subcutaneously
Andre navne:
|
|
Placebo komparator: Fluzone® HD plus Placebo
Participants will receive open-label Fluzone® HD influenza vaccine by IM injection plus placebo by SC injection on Day 1. |
Fluzone® HD injectable suspension administered by intramuscular (IM) injection
Andre navne:
MK-1406 matched liquid for SC injection |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Geometric Mean of Hemagglutinin Inhibition (HAI) Titers Against the Influenza Strains Contained in the Vaccine Among Participants Receiving Concomitant Fluzone® High-Dose (HD) and MK-1406 Compared to Participants Who Receive Fluzone® HD and Placebo
Tidsramme: Predose (Day 1), Day 15 and Day 29
|
Geometric mean of HAI titers at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. HAI testing will be performed using validated methods in accordance with applicable Good Clinical Laboratory Practice (GCLP) and laboratory Standard Operating Procedures (SOPs). Geometric Mean Titers (GMTs) will be summarized by treatment group and influenza strain. |
Predose (Day 1), Day 15 and Day 29
|
|
Percentage of Participants with Seroconversion Rates against the Influenza Strains Contained in the Vaccine Among Participants Receiving Concomitant Fluzone® HD and MK-1406 Compared to Participants Who Receive Fluzone® HD and Placebo
Tidsramme: Predose (Day 1), Day 15 and Day 29
|
Seroconversion is defined as a 4-fold increase in influenza titer as measured by HAI assay at each visit compared to baseline. Seroconversion rates at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. Seroconversion rates will be summarized by treatment group and influenza strain. |
Predose (Day 1), Day 15 and Day 29
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of participants with ≥1 Adverse Event (AE)
Tidsramme: Up to approximately Day 29
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
Up to approximately Day 29
|
|
Percentage of Participants Who Discontinued from the Study Due to an Adverse Event
Tidsramme: Up to approximately Day 29
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinued the study because of an AE (as defined above) will be assessed. |
Up to approximately Day 29
|
|
Percentage of Participants with a Solicited Injection-site Adverse Event
Tidsramme: Up to approximately Day 8 post-dose
|
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. The solicited injection-site AEs assessed are redness/erythema, swelling, and tenderness/pain. |
Up to approximately Day 8 post-dose
|
|
Percentage of Participants with a Solicited Systemic Adverse Event
Tidsramme: Up to approximately Day 29
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The solicited systemic AEs assessed are muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. |
Up to approximately Day 29
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1406-007
- CD388.SQ.1.08 (Anden identifikator: Cidara)
- MK-1406-007 (Anden identifikator: MSD)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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