- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06436703
En studie om modifiserte RNA-vaksiner mot influensa hos friske voksne
EN STUDIE FOR Å EVALUERE SIKKERHETEN, TOLERABILITETEN OG IMMUNOGENISITETEN TIL MODIFISERT RNA-VAKSIN MOT INFLUENSA HOS SUNE VOKSNE
Formålet med denne studien er å finne ut om modifiserte RNA (modRNA) vaksiner for forebygging av influensa er:
- sikker; og
- hvordan disse vaksinene produserer en immunrespons hos generelt friske voksne. Immunrespons er måten kroppen beskytter seg mot ting den ser på som skadelig eller fremmed.
RNA (også kalt ribonukleinsyre) er en av to typer nukleinsyre laget av celler. RNA inneholder informasjon som er kopiert fra DNA (den andre typen nukleinsyre). Celler lager flere forskjellige former for RNA, og hver form har en bestemt jobb i cellen. Mange former for RNA har funksjoner knyttet til å lage proteiner. RNA er også arvestoffet til noen virus i stedet for DNA. RNA kan lages i laboratoriet og brukes i forskningsstudier. Også kalt ribonukleinsyre.
Influensa er betegnelsen på influensasykdom. Det er en infeksjon forårsaket av et virus som påvirker munn, nese og svelg.
Studien søker etter deltakere som:
- er minst 18 år
- ikke har mottatt influensavaksine de siste 6 månedene
- er generelt sunne
Denne studien vil bli delt inn i tre delstudier: Delstudie A (SSA), Delstudie B (SSB), og Delstudie C (SSC).
Alle deltakere, uavhengig av delstudie, vil motta 1 dose av en av følgende vaksiner som en injeksjon i armen:
- 1 av modRNA-influensavaksinen som studeres; eller
- en godkjent influensavaksine godkjent for bruk i deres respektive aldersgruppe.
Deltakerne vil være involvert i denne studien i ca. 6 måneder. I løpet av denne tiden vil deltakerne ha minst 3 klinikkbesøk.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Alabama
-
Mobile, Alabama, Forente stater, 36608
- AMR Clinical
-
-
Arizona
-
Scottsdale, Arizona, Forente stater, 85260
- Headlands Research - Scottsdale
-
-
California
-
Anaheim, California, Forente stater, 92801
- Anaheim Clinical Trials, LLC
-
Lake Forest, California, Forente stater, 92630
- Orange County Research Center
-
San Diego, California, Forente stater, 92103
- Artemis Institute for Clinical Research
-
Walnut Creek, California, Forente stater, 94598
- Diablo Clinical Research, Inc.
-
-
Connecticut
-
Milford, Connecticut, Forente stater, 06460
- Clinical Research Consulting
-
-
Florida
-
Hialeah, Florida, Forente stater, 33012
- Indago Research & Health Center, Inc
-
Hollywood, Florida, Forente stater, 33024
- Research Centers of America
-
Hollywood, Florida, Forente stater, 33024
- Research Centers of America ( Hollywood )
-
Miami Lakes, Florida, Forente stater, 33014
- Palm Springs Community Health Center
-
Orlando, Florida, Forente stater, 32801
- Clinical Neuroscience Solutions, Inc.
-
Orlando, Florida, Forente stater, 32819
- Headlands Research Orlando
-
South Miami, Florida, Forente stater, 33143
- Qps-Mra, Llc
-
-
Hawaii
-
Honolulu, Hawaii, Forente stater, 96814
- East-West Medical Research Institute
-
-
Louisiana
-
New Orleans, Louisiana, Forente stater, 70119
- Alliance for Multispecialty Research, LLC
-
-
Minnesota
-
Saint Paul, Minnesota, Forente stater, 55114
- Prism Research LLC dba Nucleus Network
-
-
Missouri
-
Chesterfield, Missouri, Forente stater, 63005
- Clinical Research Professionals
-
Kansas City, Missouri, Forente stater, 64114
- Alliance for Multispecialty Research, LLC
-
-
New York
-
Rochester, New York, Forente stater, 14609
- Rochester Clinical Research, LLC
-
-
North Carolina
-
Durham, North Carolina, Forente stater, 27703
- Duke Vaccine and Trials Unit
-
Raleigh, North Carolina, Forente stater, 27612
- M3 Wake Research, Inc.
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19107
- DM Clinical Research - Philadelphia
-
-
Texas
-
Brownsville, Texas, Forente stater, 78526
- Headlands Horizons LLC
-
Mesquite, Texas, Forente stater, 75149
- SMS Clinical Research
-
San Antonio, Texas, Forente stater, 78229
- Clinical Trials of Texas, LLC
-
San Antonio, Texas, Forente stater, 78229
- Clinical Trials of Texas, LLC dba Flourish Research
-
Tomball, Texas, Forente stater, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
-
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Utah
-
Salt Lake City, Utah, Forente stater, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
-
Salt Lake City, Utah, Forente stater, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
-
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Virginia
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Charlottesville, Virginia, Forente stater, 22911
- Charlottesville Medical Research
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Norfolk, Virginia, Forente stater, 23502
- AMR Clinical
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Viktige inkluderingskriterier
Gjelder alle 3 delstudiene:
- deltakere ≥18 år.
- generelt friske deltakere.
KUN delstudie C:
- mottak av lisensiert influensavaksinasjon for influensasesongen 2023-2024 for minst 6 måneder siden.
Nøkkeleksklusjonskriterier
Alle 3 delstudiene:
- diagnostisering av influensa (ved klinisk testing) de siste 6 månedene.
- immunkompromitterte individer med kjent eller mistenkt immunsvikt
- mottak av eventuelle undersøkelses- eller lisensierte influensavaksiner innen 6 måneder.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: SSA: Influensa ModRNA-vaksine 2A
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSA: Influensa ModRNA-vaksine 3A
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSA: Influensa ModRNA-vaksine 4A
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSA: Influensa ModRNA-vaksine 5A
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Aktiv komparator: SSA: QIV1
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSB: Influensa ModRNA-vaksine 3B
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSB: Influensa ModRNA-vaksine 4B
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSB: Influensa ModRNA-vaksine 5B
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Aktiv komparator: SSB: QIV2
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Aktiv komparator: SSB: QIV3
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSC: Influensa ModRNA-vaksine 3C
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSC: Influensa ModRNA-vaksine 4C
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSC: Influensa ModRNA-vaksine 5C
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSC: Influensa ModRNA-vaksine 6C
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSC: Influensa ModRNA-vaksine 7C
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSC: Influensa ModRNA-vaksine 8C
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Eksperimentell: SSC: Influensa ModRNA-vaksine 9C
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Aktiv komparator: SSC: QIV2
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
|
Aktiv komparator: SSC: QIV3
- Enkeltdose på dag 1
|
Intramuskulær injeksjon
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
SSA: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
Andre studie-ID-numre
- C4781013
- NCT06436703 (Registeridentifikator: ClinicalTrials.gov)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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