A Study of Updated mRNA Seasonal Influenza Vaccines
A Phase 3b/4 Study to Assess the Immunogenicity and Safety of Updated mRNA Seasonal Influenza Vaccine Compositions
The purpose of this study is to evaluate the immunogenicity and safety of updated strain-containing compositions of the mRNA-1010 vaccines within the current epidemiological environment.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study uses a master protocol with a generic study design to allow flexibility in evaluating immunogenicity and safety of updated strain-containing compositions of the mRNA-1010 vaccines. As different strain-containing vaccine compositions will be evaluated, each study intervention will be described in the subprotocol. For each evaluation of an updated strain, a new subprotocol will be generated. Reported outcome measures are based upon each subprotocol. Not all reported outcome measures may be applicable to each subprotocol.
Subprotocol 01 is to evaluate the 2026-2027 mRNA influenza vaccine.
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Moderna WeCare Team
- Telefonnummer: 1-866-663-3762
- E-post: WeCareClinicalTrials@modernatx.com
Studiesteder
-
-
Arizona
-
Tucson, Arizona, Forente stater, 85711
- Rekruttering
- Arizona Clinical Trials
-
-
Kansas
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Lenexa, Kansas, Forente stater, 66219
- Rekruttering
- Johnson County Clin-Trials LLC (JCCT)
-
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Kentucky
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Louisville, Kentucky, Forente stater, 40205
- Rekruttering
- DelRicht Research at Derby City Direct Primary Care
-
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Missouri
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Town and Country, Missouri, Forente stater, 63017
- Rekruttering
- DelRicht Research at Amy Roberts MD and Associates
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Key Inclusion Criteria:
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Female participants must be of non-childbearing potential.
Key Exclusion Criteria:
- Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) [100.4° Fahrenheit [F]]) within 72 hours prior to at the Screening Visit or Day 1.
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, could interfere with interpretation of study results or limit the participant's participation in the study.
- History of myocarditis, pericarditis, or myopericarditis within 90 days prior to Day 1 (Baseline).
- Received corticosteroids at ≥10 mg/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 (Baseline) or within 28 days after Day 1.
- Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to Day 1 (Baseline) or plans to do so during the study.
- Tested positive for influenza by US Centers for Disease Control and Prevention (CDC)-recommended testing methods within 180 days prior to Day 1.
- Received systemic immunoglobulins or blood products within 90 days prior to Day 1 (Baseline) or plans to do so during the study.
- Received any vaccine (excluding seasonal influenza vaccine) authorized or approved by local health agency within 28 days prior to Day 1 (Baseline) or plans to do so within 14 days after Day 1 (Baseline).
- Received a licensed or investigational seasonal influenza vaccine within 6 months prior to Day 1 (Baseline) or plans to do so (outside of this study) at any time during the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: mRNA-1010 Influenza Strain-containing Composition (2026- 2027)
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1. |
Sterile liquid for injection |
|
Aktiv komparator: Licensed High-Dose Seasonal Influenza Vaccine
Participants will receive a single dose of licensed high-dose seasonal influenza vaccine by IM injection on Day 1. |
Sterile liquid for injection |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Geometrisk middeltiter (GMT) av anti-hemagglutinin (HA) antistoffer på dag 29, målt ved hemagglutinasjonshemming (HAI) assay
Tidsramme: Dag 29
|
Dag 29
|
|
|
Number of Participants Reaching Seroconversion at Day 29 as Measured by HAI Assay
Tidsramme: Day 29
|
Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay. |
Day 29
|
|
Number of Participants with an HAI Titer ≥1:40 at Day 29
Tidsramme: Day 29
|
Day 29
|
|
|
Geometric Mean Fold Rise (GMFR), as Measured by HAI Assay
Tidsramme: Baseline to Day 29
|
Baseline to Day 29
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Participants with Unsolicited Adverse Events (AEs)
Tidsramme: Day 1 through Day 29
|
Day 1 through Day 29
|
|
Number of Participants with Serious AEs, Medical-attended AEs and AE of Interest, and AEs Leading to Discontinuation
Tidsramme: Day 1 through Day 29
|
Day 1 through Day 29
|
Samarbeidspartnere og etterforskere
Sponsor
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
- Luftveisinfeksjoner
- Infeksjoner
- Orthomyxoviridae-infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Sykdommer i luftveiene
- Influensa, menneske
- Helsevesenets kvalitet, tilgang og evaluering
- Helsevesenets økonomi og organisasjoner
- Kvalitetssikring, helsehjelp
- Sosial kontroll, formell
- Credentialing
- MRNA-1010 Influensavaksine
- Licensure
Andre studie-ID-numre
- mRNA-1010-P401
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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