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Uno studio sui vaccini a RNA modificato contro l’influenza negli adulti sani

9 giugno 2026 aggiornato da: Pfizer

UNO STUDIO PER VALUTARE LA SICUREZZA, LA TOLLERABILITÀ E L'IMMUNOGENICITÀ DEI VACCINI A RNA MODIFICATO CONTRO L'INFLUENZA NEGLI ADULTI SANI

Lo scopo di questo studio è scoprire se i vaccini a RNA modificato (modRNA) per la prevenzione dell'influenza sono:

  • sicuro; E
  • come questi vaccini producono una risposta immunitaria negli adulti generalmente sani. La risposta immunitaria è il modo in cui il corpo si protegge da cose che considera dannose o estranee.

L'RNA (chiamato anche acido ribonucleico) è uno dei due tipi di acido nucleico prodotti dalle cellule. L'RNA contiene informazioni che sono state copiate dal DNA (l'altro tipo di acido nucleico). Le cellule producono diverse forme di RNA e ciascuna forma ha un lavoro specifico nella cellula. Molte forme di RNA hanno funzioni legate alla produzione di proteine. L'RNA è anche il materiale genetico di alcuni virus al posto del DNA. L'RNA può essere prodotto in laboratorio e utilizzato negli studi di ricerca. Chiamato anche acido ribonucleico.

L'influenza è il termine usato per la malattia influenzale. È un'infezione causata da un virus che colpisce la bocca, il naso e la gola.

Lo studio è alla ricerca di partecipanti che:

  • hanno almeno 18 anni
  • non hanno ricevuto un vaccino antinfluenzale negli ultimi 6 mesi
  • sono generalmente sani

Questo studio sarà diviso in tre sottostudi: sottostudio A (SSA), sottostudio B (SSB) e sottostudio C (SSC).

Tutti i partecipanti, indipendentemente dal sottostudio, riceveranno 1 dose di uno dei seguenti vaccini come iniezione nel braccio:

  • 1 dei vaccini antinfluenzali modRNA in fase di studio; O
  • un vaccino antinfluenzale approvato per l'uso nella rispettiva fascia di età.

I partecipanti saranno coinvolti in questo studio per circa 6 mesi. Durante questo periodo, i partecipanti avranno almeno 3 visite cliniche.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1202

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Mobile, Alabama, Stati Uniti, 36608
        • AMR Clinical
    • Arizona
      • Scottsdale, Arizona, Stati Uniti, 85260
        • Headlands Research - Scottsdale
    • California
      • Anaheim, California, Stati Uniti, 92801
        • Anaheim Clinical Trials, LLC
      • Lake Forest, California, Stati Uniti, 92630
        • Orange County Research Center
      • San Diego, California, Stati Uniti, 92103
        • Artemis Institute for Clinical Research
      • Walnut Creek, California, Stati Uniti, 94598
        • Diablo Clinical Research, Inc.
    • Connecticut
      • Milford, Connecticut, Stati Uniti, 06460
        • Clinical Research Consulting
    • Florida
      • Hialeah, Florida, Stati Uniti, 33012
        • Indago Research & Health Center, Inc
      • Hollywood, Florida, Stati Uniti, 33024
        • Research Centers of America
      • Hollywood, Florida, Stati Uniti, 33024
        • Research Centers of America ( Hollywood )
      • Miami Lakes, Florida, Stati Uniti, 33014
        • Palm Springs Community Health Center
      • Orlando, Florida, Stati Uniti, 32801
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, Stati Uniti, 32819
        • Headlands Research Orlando
      • South Miami, Florida, Stati Uniti, 33143
        • Qps-Mra, Llc
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti, 96814
        • East-West Medical Research Institute
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti, 70119
        • Alliance for Multispecialty Research, LLC
    • Minnesota
      • Saint Paul, Minnesota, Stati Uniti, 55114
        • Prism Research LLC dba Nucleus Network
    • Missouri
      • Chesterfield, Missouri, Stati Uniti, 63005
        • Clinical Research Professionals
      • Kansas City, Missouri, Stati Uniti, 64114
        • Alliance for Multispecialty Research, LLC
    • New York
      • Rochester, New York, Stati Uniti, 14609
        • Rochester Clinical Research, LLC
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27703
        • Duke Vaccine and Trials Unit
      • Raleigh, North Carolina, Stati Uniti, 27612
        • M3 Wake Research, Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • DM Clinical Research - Philadelphia
    • Texas
      • Brownsville, Texas, Stati Uniti, 78526
        • Headlands Horizons LLC
      • Mesquite, Texas, Stati Uniti, 75149
        • SMS Clinical Research
      • San Antonio, Texas, Stati Uniti, 78229
        • Clinical Trials of Texas, LLC
      • San Antonio, Texas, Stati Uniti, 78229
        • Clinical Trials of Texas, LLC dba Flourish Research
      • Tomball, Texas, Stati Uniti, 77375
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84109
        • J. Lewis Research, Inc. / Foothill Family Clinic
      • Salt Lake City, Utah, Stati Uniti, 84121
        • J. Lewis Research, Inc. / Foothill Family Clinic South
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22911
        • Charlottesville Medical Research
      • Norfolk, Virginia, Stati Uniti, 23502
        • AMR Clinical

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

Criteri chiave di inclusione

Si applica a tutti e 3 i sottostudi:

  • partecipanti di età ≥18 anni.
  • partecipanti generalmente sani.

SOLO sottostudio C:

- ricezione della vaccinazione antinfluenzale autorizzata per la stagione influenzale 2023-2024 almeno 6 mesi fa.

Criteri chiave di esclusione

Tutti e 3 i sottostudi:

  • diagnosi di influenza (mediante test clinici) negli ultimi 6 mesi.
  • soggetti immunocompromessi con immunodeficienza nota o sospetta
  • ricezione di eventuali vaccini antinfluenzali sperimentali o autorizzati entro 6 mesi.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: SSA: vaccino antinfluenzale ModRNA 2A
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Sperimentale: SSA: vaccino antinfluenzale ModRNA 3A
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Sperimentale: SSA: vaccino antinfluenzale ModRNA 4A
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Sperimentale: SSA: vaccino antinfluenzale ModRNA 5A
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Comparatore attivo: SSA: QIV1
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale quadrivalente (QIV)
Iniezione intramuscolare
Sperimentale: SSB: vaccino antinfluenzale ModRNA 3B
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Sperimentale: SSB: vaccino antinfluenzale ModRNA 4B
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Sperimentale: SSB: vaccino antinfluenzale ModRNA 5B
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Comparatore attivo: SSB: QIV2
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale quadrivalente (QIV)
Iniezione intramuscolare
Comparatore attivo: SSB: QIV3
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale quadrivalente (QIV)
Iniezione intramuscolare
Sperimentale: SSC: vaccino antinfluenzale ModRNA 3C
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Sperimentale: SSC: vaccino antinfluenzale ModRNA 4C
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Sperimentale: SSC: vaccino antinfluenzale ModRNA 5C
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Sperimentale: SSC: vaccino antinfluenzale ModRNA 6C
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Sperimentale: SSC: vaccino antinfluenzale ModRNA 7C
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Sperimentale: SSC: vaccino antinfluenzale ModRNA 8C
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Sperimentale: SSC: vaccino antinfluenzale ModRNA 9C
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale ModRNA
Iniezione intramuscolare
Comparatore attivo: SSC: QIV2
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale quadrivalente (QIV)
Iniezione intramuscolare
Comparatore attivo: SSC: QIV3
- Dose singola il giorno 1
Biologico: Vaccino antinfluenzale quadrivalente (QIV)
Iniezione intramuscolare

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
SSA: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Lasso di tempo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. All local reactions were graded based on center for biologics evaluation and research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSB: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Lasso di tempo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSC: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Lasso di tempo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSA: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Lasso di tempo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSB: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Lasso di tempo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSC: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Lasso di tempo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSA: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
Lasso di tempo: From study vaccination on Day 1 through 4 weeks after study vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From study vaccination on Day 1 through 4 weeks after study vaccination
SSB: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
Lasso di tempo: From study vaccination on Day 1 through 4 weeks after study vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From study vaccination on Day 1 through 4 weeks after study vaccination
SSC: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
Lasso di tempo: From study vaccination on Day 1 through 4 weeks after study vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From study vaccination on Day 1 through 4 weeks after study vaccination
SSA: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
Lasso di tempo: From study vaccination on Day 1 through 6 months after study vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
From study vaccination on Day 1 through 6 months after study vaccination
SSB: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
Lasso di tempo: From study vaccination on Day 1 through 6 months after study vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
From study vaccination on Day 1 through 6 months after study vaccination
SSC: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
Lasso di tempo: From study vaccination on Day 1 through 6 months after study vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
From study vaccination on Day 1 through 6 months after study vaccination
SSA: Percentage of Participants With Medically Attended Adverse Events (MAEs) From Vaccination Through 6 Months After Vaccination
Lasso di tempo: From study vaccination on Day 1 through 6 months after study vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From study vaccination on Day 1 through 6 months after study vaccination
SSB: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
Lasso di tempo: From study vaccination on Day 1 through 6 months after study vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From study vaccination on Day 1 through 6 months after study vaccination
SSC: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
Lasso di tempo: From study vaccination on Day 1 through 6 months after study vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From study vaccination on Day 1 through 6 months after study vaccination
SSA: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Through 6 Months After Vaccination
Lasso di tempo: From study vaccination on Day 1 through 6 months after study vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
From study vaccination on Day 1 through 6 months after study vaccination
SSB: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
Lasso di tempo: From study vaccination on Day 1 through 6 months after study vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
From study vaccination on Day 1 through 6 months after study vaccination
SSC: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
Lasso di tempo: From study vaccination on Day 1 through 6 months after study vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
From study vaccination on Day 1 through 6 months after study vaccination

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
Lasso di tempo: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
GMTs and the corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
SSA: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
Lasso di tempo: From before study vaccination on Day 1 up to 4 weeks after study vaccination
GMFR was defined as the geometric mean of the fold rise in the assay results from before vaccination to a specified time point after vaccination.
From before study vaccination on Day 1 up to 4 weeks after study vaccination
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
Lasso di tempo: 4 weeks after study vaccination
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with at least a 4-fold rise at the time point of interest.
4 weeks after study vaccination
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
Lasso di tempo: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
Lasso di tempo: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
SSB: GMFRs of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
Lasso di tempo: From before study vaccination on Day 1 up to 4 weeks after study vaccination
From before study vaccination on Day 1 up to 4 weeks after study vaccination
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
Lasso di tempo: 4 weeks after study vaccination
4 weeks after study vaccination
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
Lasso di tempo: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Investigatori

  • Direttore dello studio: Pfizer CT.gov Call Center, Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 maggio 2024

Completamento primario (Effettivo)

5 febbraio 2025

Completamento dello studio (Effettivo)

5 febbraio 2025

Date di iscrizione allo studio

Primo inviato

24 maggio 2024

Primo inviato che soddisfa i criteri di controllo qualità

30 maggio 2024

Primo Inserito (Effettivo)

31 maggio 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C4781013
  • NCT06436703 (Identificatore di registro: ClinicalTrials.gov)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Pfizer fornirà l'accesso ai dati dei singoli partecipanti non identificati e ai relativi documenti di studio (ad es. protocollo, Piano di Analisi Statistica (SAP), Rapporto di Studio Clinico (CSR)) su richiesta di ricercatori qualificati e soggetto a determinati criteri, condizioni ed eccezioni. Ulteriori dettagli sui criteri di condivisione dei dati di Pfizer e sul processo di richiesta di accesso sono disponibili all'indirizzo: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Influenza, umana

Prove cliniche su Vaccino antinfluenzale ModRNA

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Brazil

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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