Uno studio per conoscere l'influenza e le risposte al vaccino contro il vaccino in persone sane
Uno studio di fase 1/2, randomizzato, in cieco per osservatori per valutare la sicurezza, la tollerabilità e l'immunogenicità dei candidati a vaccini combinati contro l'influenza e Covid-19 in soggetti sani
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
California
-
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
-
Miami, Florida, Stati Uniti, 33176
- Miami Dade Medical Research Institute, LLC
-
Miami Lakes, Florida, Stati Uniti, 33014
- Palm Springs Community Health Center
-
Orlando, Florida, Stati Uniti, 32819
- Headlands Research Orlando
-
-
Georgia
-
Stockbridge, Georgia, Stati Uniti, 30281
- Clinical Research Atlanta
-
-
Hawaii
-
Honolulu, Hawaii, Stati Uniti, 96814
- East-West Medical Research Institute
-
-
Missouri
-
Chesterfield, Missouri, Stati Uniti, 63005
- Clinical Research Professionals
-
Springfield, Missouri, Stati Uniti, 65802
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO
-
Springfield, Missouri, Stati Uniti, 65807
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
-
-
Nebraska
-
Omaha, Nebraska, Stati Uniti, 68134
- Velocity Clinical Research, Omaha
-
-
Nevada
-
Las Vegas, Nevada, Stati Uniti, 89030
- Las Vegas Clinical Trials
-
-
New Hampshire
-
Portsmouth, New Hampshire, Stati Uniti, 03801
- ActivMed Practices & Research, LLC.
-
-
Texas
-
Houston, Texas, Stati Uniti, 77065
- DM Clinical Research- Cyfair
-
Mesquite, Texas, Stati Uniti, 75149
- SMS Clinical 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
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Criteri di inclusione:
- Partecipanti di età pari o superiore a 18 anni
- I partecipanti sani determinati dalla storia medica, dall'esame fisico (se clinicamente richiesto) e al giudizio clinico dell'investigatore possono essere ammissibili per l'inclusione nello studio.
Criteri di esclusione:
- VACCINAZIONE CON QUALSIASI INGUQUI INTERESTIMENTI O LUCIFICAZIONE DELLA FORMULAZIONE DELLA STAGIONE DELL'INFINGENZA DELL'INTERNO o COVID-19 VACINE.
- Trattato con terapie antivirali per l'influenza (ad es. Tamiflu) entro 180 giorni prima del giorno 1
Fare riferimento al contatto dello studio per ulteriori dettagli di ammissibilità.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: Arm A/AA
Low Dose COVID-19 Vaccine and Placebo
|
Salino
Pfizer-Biontech vaccino Covid-19
|
|
Sperimentale: Arm B/BB
Medium Dose COVID-19 Vaccine and Placebo
|
Salino
Pfizer-Biontech vaccino Covid-19
|
|
Comparatore attivo: Arm C/CC
High Dose COVID-19 Vaccine and Placebo
|
Salino
Pfizer-Biontech vaccino Covid-19
|
|
Sperimentale: Arm D/DD
Low Dose Investigational Influenza Vaccine and Placebo
|
Salino
Vaccino antinfluenzale studiato
|
|
Comparatore attivo: Arm E
Licensed Influenza Vaccine 1 and Licensed COVID-19 Vaccine
|
Pfizer-Biontech vaccino Covid-19
Vaccino antinfluenzale autorizzato 1
|
|
Comparatore attivo: Arm EE
Licensed Influenza Vaccine 2 and Licensed COVID-19 Vaccine
|
Pfizer-Biontech vaccino Covid-19
Vaccino antinfluenzale autorizzato 2
|
|
Sperimentale: Arm F/FF
Medium Dose Investigational Influenza Vaccine and Placebo
|
Salino
Vaccino antinfluenzale studiato
|
|
Sperimentale: Arm G/GG
Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Salino
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Sperimentale: Arm H/HH
Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine and Placebo
|
Salino
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Sperimentale: Arm I/II
Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Salino
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Sperimentale: Arm J/JJ
High Dose Investigational Influenza Vaccine and Placebo
|
Salino
Vaccino antinfluenzale studiato
|
|
Sperimentale: Arm K/KK
Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Salino
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Sperimentale: Arm L/LL
Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Salino
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Sperimentale: Arm M/MM
High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Salino
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Sperimentale: Arm N
High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Salino
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
Lasso di tempo: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination.
Local reactions were graded per the 'Local Reaction Grading Scale' per protocol.
Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
|
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
|
Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
Lasso di tempo: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination.
Local reactions were graded per the 'Local Reaction Grading Scale' per protocol.
Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
|
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
|
Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
Lasso di tempo: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination.
Systemic events were graded per the 'Systemic Events Grading Scale' per protocol.
Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
|
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
|
Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
Lasso di tempo: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination.
Systemic events were graded per the 'Systemic Events Grading Scale' per protocol.
Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
|
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
|
Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination
Lasso di tempo: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
|
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
AEs included both serious and all non-serious AEs.
Serious AE (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.
Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
|
From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
|
|
Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 1 Month After Vaccination
Lasso di tempo: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
|
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
AEs included both serious and all non-serious AEs.
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.
Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
|
From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
|
|
Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
Lasso di tempo: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
|
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, and any other pre-specified criteria in protocol of the study or other important medical event.
Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events [if any]) were included in this outcome measure.
|
From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
|
|
Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
Lasso di tempo: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
|
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, and any other pre-specified criteria in protocol of the study or other important medical event.
Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events [if any]) were included in this outcome measure.
|
From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
|
Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Direttore dello studio: Pfizer CT.gov Call Center, Pfizer
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Infezioni delle vie respiratorie
- Infezioni
- Infezioni da Orthomyxoviridae
- Infezioni da virus a RNA
- Malattie virali
- Malattie delle vie respiratorie
- Malattie polmonari
- Polmonite, virale
- Polmonite
- Infezioni da coronavirus
- Infezioni da Coronaviridae
- Infezioni da Nidovirus
- COVID-19
- Influenza, umana
- Prodotti biologici
- Miscele complesse
- Vaccini
- Vaccini virali
- Vaccini contro il covid-19
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- C5261023
- C5261023-C1; C5261023-C2 (Altro identificatore: Alias Study Number)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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 .