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Undersøgelse af monovalente og bivalente rekombinante proteinvacciner mod COVID-19 hos voksne 18 år og ældre (VAT00008)

6. maj 2026 opdateret af: Sanofi Pasteur, a Sanofi Company

En parallelgruppe, fase III, flertrins, modificeret dobbeltblind, multiarmet undersøgelse for at vurdere effektiviteten, sikkerheden og immunogeniciteten af to SARS-CoV-2 adjuverede rekombinante proteinvacciner (monovalent og bivalent) til forebyggelse mod COVID -19 hos voksne 18 år og ældre som en primær serie og åben udvidelse til vurdering af immunogenicitet, sikkerhed, effektivitet af en monovalent boosterdosis af SARS-CoV2 adjuveret rekombinant proteinvaccine

Formålet med dette fase III-studie er at vurdere effektiviteten, sikkerheden og immunogeniciteten af to CoV2 preS dTM-AS03-vacciner (monovalent og bivalent) som en del af primære serievaccinationer i en flertrinstilgang, samt en booster-injektion af en CoV2 preS dTM-AS03-vaccine til voksne 18 år og ældre.

I alt ca. 21 046 deltagere er planlagt til at blive indskrevet (5080 pr. undersøgelsesinterventionsgruppe i trin 1 og 5443 pr. undersøgelsesinterventionsgruppe i trin 2).

Indledende, dobbeltblindede, primære serieundersøgelsesdesign er planlagt til 365 dage efter den sidste initiale injektion (dvs. ca. 386 dage i alt) for hver deltager.

Baseret på beslutninger fra Studietilsynsgruppen, vil trin 1- og trin 2-deltagere blive inviteret til at deltage i et ublindet Crossover / Booster-studiedesign med varighed som følger:

For deltagere, der oprindeligt modtog vaccine: 12 måneder efter booster (dvs. ca. 18 til 24 måneder)
For deltagere, der oprindeligt fik placebo: ≥ 4 måneder efter sidste dosis af den primære serie + 12 måneder efter booster (dvs. ca. 28 til 34 måneder)
For deltagere, der ikke giver samtykke til at fortsætte i den ublindede Crossover/Booster-del af undersøgelsen, vil alle undersøgelsesprocedurer blive stoppet, og deltagerne vil blive afbrudt fra undersøgelsen.

Studieoversigt

Status

Afsluttet

Betingelser

COVID-19

Intervention / Behandling

Detaljeret beskrivelse

Varigheden af deltagelse i det indledende, dobbeltblindede, primære seriedesign af undersøgelsen vil være ca. 365 dage efter sidste injektion (dvs. ca. 386 dage i alt) for hver deltager.

Baseret på beslutninger fra undersøgelsens OG, vil trin 1- og trin 2-deltagere blive inviteret til at deltage i et ublindet Crossover / Booster-studiedesign med varighed som følger:

For deltagere, der oprindeligt modtog vaccine: 12 måneder efter booster (dvs. ca. 18 til 24 måneder)
For deltagere, der oprindeligt fik placebo: ≥ 4 måneder efter sidste dosis af den primære serie + 12 måneder efter booster (dvs. ca. 28 til 34 måneder)
For deltagere, der ikke giver samtykke til at fortsætte i den ublindede Crossover/Booster-del af undersøgelsen, vil alle undersøgelsesprocedurer blive stoppet, og deltagerne vil blive afbrudt fra undersøgelsen.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

23670

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Colombia
- - Aguazul, Colombia, 856018
    - Investigational Site Number : 1700010
  - Barranquilla, Colombia, 080020
    - Investigational Site Number : 1700002
  - Barranquilla, Colombia, 080020
    - Investigational Site Number : 1700008
  - Bogotá, Colombia, 111611
    - Investigational Site Number : 1700001
  - Cali, Colombia, 76001
    - Investigational Site Number : 1700005
  - Chía, Colombia, 0000
    - Investigational Site Number : 1700006
  - Floridablanca, Colombia, 681004
    - Investigational Site Number : 1700004
  - Girardot, Colombia, 252431
    - Investigational Site Number : 1700007
  - Meta, Colombia, 0000
    - Investigational Site Number : 1700009
  - Quindío, Colombia, 630001
    - Investigational Site Number : 1700015
  - Soledad, Colombia, 083001
    - Investigational Site Number : 1700003
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35211
    - AES - DRS - Simon Williamson Clinic, PC - Birmingham- Site Number : 8400004
  - Huntsville, Alabama, Forenede Stater, 35802
    - Optimal Research Alabama- Site Number : 8400019
- California
  - Rolling Hills Estates, California, Forenede Stater, 90274
    - Peninsula Research Associates, Inc.- Site Number : 8400021
- Colorado
  - Centennial, Colorado, Forenede Stater, 80112
    - Synexus Clinical Research US, Inc. Site Number : 8400013
- Florida
  - Melbourne, Florida, Forenede Stater, 32934
    - Optimal Research, LLC-Melbourne- Site Number : 8400002
  - Orlando, Florida, Forenede Stater, 32806
    - Synexus Clinical Research US, Inc. - Orlando- Site Number : 8400020
  - Pinellas Park, Florida, Forenede Stater, 33781
    - AES St. Petersburg- Site Number : 8400017
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30328
    - Synexus Clinical Research US, Inc. - Atlanta- Site Number : 8400005
- Illinois
  - Chicago, Illinois, Forenede Stater, 60602
    - Synexus Clinical Research Chicago- Site Number : 8400012
- Indiana
  - Evansville, Indiana, Forenede Stater, 47714
    - Synexus Clinical Research Evansville- Site Number : 8400008
- Missouri
  - St Louis, Missouri, Forenede Stater, 63141
    - Synexus St. Louis- Site Number : 8400006
- Nevada
  - Henderson, Nevada, Forenede Stater, 89052
    - Synexus Clinical Research US, Inc. - Henderson- Site Number : 8400018
- New York
  - Rochester, New York, Forenede Stater, 14609
    - Rochester Clinical Research, Inc.- Site Number : 8400023
- Ohio
  - Akron, Ohio, Forenede Stater, 44311
    - Synexus Akron- Site Number : 8400009
  - Cincinnati, Ohio, Forenede Stater, 45236
    - Synexus Clinical Research US, Inc. - Cincinnati- Site Number : 8400010
  - Columbus, Ohio, Forenede Stater, 43212
    - Synexus US Columbus- Site Number : 8400011
- South Carolina
  - Anderson, South Carolina, Forenede Stater, 29621
    - Synexus Clinical Research Anderson- Site Number : 8400007
  - North Charleston, South Carolina, Forenede Stater, 29405
    - Coastal Carolina Research Center - N Charleston- Site Number : 8400022
- South Dakota
  - Rapid City, South Dakota, Forenede Stater, 57701
    - American Indian Clinical Trials Research Network Site Number : 8400025
- Texas
  - Austin, Texas, Forenede Stater, 78744
    - AES Austin- Site Number : 8400003
  - Dallas, Texas, Forenede Stater, 75231
    - Synexus Dallas- Site Number : 8400014
  - San Antonio, Texas, Forenede Stater, 78229
    - Synexus Clinical Research US, Inc. - San Antonio- Site Number : 8400015
- Utah
  - Murray, Utah, Forenede Stater, 84123
    - AES Salt Lake City- Site Number : 8400016
Ghana
- - Kintampo, Ghana, P. O. Box 200
    - Investigational Site Number : 2880002
  - Kumasi, Ghana, 00000
    - Investigational Site Number : 2880003
  - Navrongo, Ghana, 114
    - Investigational Site Number : 2880001
Honduras
- - Municipio Del Distrito Central, Honduras, 11101
    - Investigational Site Number : 3400001
  - San Pedro Sula, Honduras, 21104
    - Investigational Site Number : 3400002
Indien
- - Ajmer, Indien, 305001
    - Investigational Site Number : 3560010
  - Ambawadi, Indien, 380015
    - Investigational Site Number : 3560002
  - Belagavi, Indien, 590002
    - Investigational Site Number : 3560007
  - Jaipur, Indien, 302039
    - Investigational Site Number : 3560001
  - Kanpur, Indien, 208002
    - Investigational Site Number : 3560005
  - Nagpur, Indien, 440001
    - Investigational Site Number : 3560009
  - Odisha, Indien, 751003
    - Investigational Site Number : 3560011
  - Patna, Indien, 801507
    - Investigational Site Number : 3560004
  - Punjagutta, Indien, 500082
    - Investigational Site Number : 3560003
  - Tamilnadu, Indien, 603203
    - Investigational Site Number : 3560006
Japan
- Tokyo
  - Chiyoda-ku,, Tokyo, Japan, 101-0041
    - Investigational Site Number : 3920005
  - Haramachi,Shinjuku-ku, Tokyo, Japan, 162-0053
    - Investigational Site Number : 3920004
  - Kouenji minami,Suginami-ku, Tokyo, Japan, 166-0003
    - Investigational Site Number : 3920003
  - Kyobashi Chuo-ku, Tokyo, Japan, 104-0031
    - Investigational Site Number : 3920001
  - Ohta-ku, Tokyo, Japan, 143-0015
    - Investigational Site Number : 3920002
Kenya
- - Butere, Kenya, 50101
    - Investigational Site Number : 4040011
  - Eldoret, Kenya, 30100
    - Investigational Site Number : 4040006
  - Kericho, Kenya, 00200
    - Investigational Site Number : 4040004
  - Kisumu, Kenya, 40100
    - Investigational Site Number : 4040002
  - Kisumu, Kenya, 40100
    - Investigational Site Number : 4040003
  - Kisumu, Kenya, 40123 Kisumu
    - Investigational Site Number : 4040012
  - Mombasa, Kenya, 80107 Ganjoni
    - Investigational Site Number : 4040008
  - Nairobi, Kenya, 00100GPO
    - Investigational Site Number : 4040001
  - Nairobi, Kenya, 00100
    - Investigational Site Number : 4040007
  - Thika, Kenya, 00202 Kiambu
    - Investigational Site Number : 4040009
Mexico
- - Temixco, Mexico, 62587
    - Investigational Site Number : 4840006
  - Veracruz, Mexico, 91910
    - Investigational Site Number : 4840002
- Guanajuato
  - León, Guanajuato, Mexico, 37000
    - Investigational Site Number : 4840005
- Guerrero
  - Acapulco de Juárez, Guerrero, Mexico, 39670
    - Investigational Site Number : 4840004
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44280
    - Investigational Site Number : 4840003
- Mexico City
  - Mexico City, Mexico City, Mexico, 04530
    - Investigational Site Number : 4840009
- Morelos
  - Cuernavaca, Morelos, Mexico, 62290
    - Investigational Site Number : 4840008
Nepal
- - Dhulikhel, Nepal, 45200
    - Investigational Site Number : 5240002
  - Kathmandu, Nepal, 44600
    - Investigational Site Number : 5240003
  - Nepalgunj, Nepal, 21900
    - Investigational Site Number : 5240001
Uganda
- - Entebbe, Uganda
    - Investigational Site Number : 8000002
  - Entebbe, Uganda
    - Investigational Site Number : 8000005
  - Kampala, Uganda
    - Investigational Site Number : 8000001
  - Kampala, Uganda, 10101
    - Investigational Site Number : 8000013
  - Kampala, Uganda, 23491
    - Investigational Site Number : 8000007
  - Kampala, Uganda, 42 Nakasero Road
    - Investigational Site Number : 8000003
  - Kampala, Uganda, Plot 101, Lubowa
    - Investigational Site Number : 8000004
  - Lira, Uganda, 10101
    - Investigational Site Number : 8000014
Ukraine
- - Kiev, Ukraine, 04210
    - Investigational Site Number : 8040002
  - Kyiv, Ukraine, 01023
    - Investigational Site Number : 8040004
  - Kyiv, Ukraine, 02002
    - Investigational Site Number : 8040003
  - Kyiv, Ukraine, 03037
    - Investigational Site Number : 8040001

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Beskrivelse

Inklusionskriterier:

Er 18 år eller ældre på optagelsesdagen.
For personer, der lever med humant immundefektvirus (HIV), stabil HIV-infektion bestemt af deltageren i øjeblikket på antiretrovirale midler med CD4-tal > 200/mm3.
SARS-CoV-2 hurtig serodiagnostisk test udført på tidspunktet for indskrivningen for at påvise tilstedeværelsen af SARS-CoV-2 antistoffer.
Har ikke til hensigt at modtage en autoriseret/godkendt COVID-19-vaccine på trods af opfordring fra investigator om at modtage den autoriserede vaccine, som er tilgængelig for dem på tilmeldingstidspunktet.
Formularen til informeret samtykke er underskrevet og dateret
I stand til at deltage i alle besøg og overholde alle undersøgelsesprocedurer
Dækket af sygeforsikring, kun hvis det kræves af lokale, regionale eller nationale regler
En kvindelig deltager er berettiget til at deltage, hvis hun ikke er gravid eller ammer, og en af følgende betingelser gælder:
- er af ikke-fertilitet. For at blive betragtet som ikke-fertil skal en kvinde være postmenopausal i mindst 1 år eller kirurgisk steril, eller
- er i den fødedygtige alder og accepterer at bruge en effektiv præventionsmetode eller afholdenhed fra mindst 4 uger før den første undersøgelsesinterventionsadministration indtil mindst 12 uger efter den anden undersøgelsesinterventionsadministration.

En deltager i den fødedygtige alder skal have en negativ meget følsom graviditetstest (urin eller serum som krævet af lokal lovgivning) inden for 25 timer før enhver dosis af undersøgelsesintervention.

Ekskluderingskriterier:

Kendt systemisk overfølsomhed over for nogen af vaccinens komponenter eller historie med en livstruende reaktion på en vaccine, der indeholder et eller flere af de samme stoffer.
Demens eller enhver anden kognitiv tilstand på et stadie, der kunne interferere med at følge undersøgelsesprocedurerne baseret på Investigator's dom.
Selvrapporteret trombocytopeni, kontraindikerende intramuskulær (IM) vaccination baseret på Investigators's dom
Blødningsforstyrrelse eller modtagelse af antikoagulantia inden for de seneste 21 dage forud for inklusion, kontraindikerende IM-vaccination baseret på efterforskerens dom.
Ustabil akut eller kronisk sygdom, som efter efterforskerens eller den udpegedes mening udgør yderligere risiko som følge af deltagelse, eller som kan forstyrre undersøgelsesprocedurerne.
Moderat eller svær akut sygdom/infektion (ifølge investigators vurdering) på vaccinationsdagen eller febril sygdom (temperatur ? 38,0 C [? 100,4 F]). En potentiel deltager bør ikke inkluderes i undersøgelsen, før tilstanden er forsvundet, eller feberhændelsen er aftaget.
Modtagelse af enhver vaccine i de 30 dage forud for eller på dagen for den første undersøgelsesvaccination eller planlagt modtagelse af enhver vaccine mellem den første undersøgelsesvaccination og i de 30 dage efter den anden undersøgelsesvaccination undtagen influenzavaccination, som kan modtages på ethvert tid i forhold til studieintervention.
Forudgående administration af en coronavirus-vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome).
Modtagelse af organ- eller knoglemarvstransplantationer inden for de seneste 180 dage.
Modtagelse af kemoterapi mod kræft inden for de sidste 90 dage.
Frihedsberøvet ved en administrativ eller retskendelse, eller i nødsituationer, eller ufrivilligt indlagt.
Identificeret som en efterforsker eller ansat i efterforskeren eller studiecentret med direkte involvering i den foreslåede undersøgelse, eller identificeret som et umiddelbar familiemedlem (dvs. forælder, ægtefælle, naturligt eller adopteret barn) til efterforskeren eller medarbejder med direkte involvering i den foreslåede undersøgelse. undersøgelse.
Deltagelse på tidspunktet for studietilmelding (eller i de 30 dage forud for den første undersøgelsesvaccination) eller planlagt deltagelse i den nuværende undersøgelsesperiode i en anden klinisk undersøgelse, der undersøger en vaccine, lægemiddel, medicinsk udstyr eller medicinsk procedure.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Forebyggelse
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Firedobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Trin 1: SARS-CoV-2-vaccine 2 injektioner af monovalent SARS-CoV-2-vaccine på dag 1 og dag 22	Biologisk: SARS-CoV-2 adjuveret rekombinant proteinvaccine (monovalent D614) (primær serie) Lægemiddelform: emulsion til injektion. Administrationsvej: intramuskulær injektion Biologisk: SARS-CoV-2 adjuveret rekombinant proteinvaccine (monovalent B.1.351) (boosterdosis) >= 4 måneder efter sidste vaccination Lægemiddelform: emulsion til injektion. Administrationsvej: intramuskulær injektion.
Placebo komparator: Trin 1: Placebo 2 injektioner af placebo på dag 1 og dag 22	Biologisk: Placebo Lægemiddelform: flydende. Administrationsvej: intramuskulær administration. Biologisk: SARS-CoV-2 adjuveret rekombinant proteinvaccine(monovalent D614)(primær serie)& SARS-CoV-2 adjuveret rekombinant proteinvaccine(monovalent B.1.351)(boosterdosis)>=4 måneder efter sidste vaccination Lægemiddelform: emulsion til injektion. Administrationsvej: intramuskulær injektion.
Eksperimentel: Trin 2: SARS-CoV-2-vaccine 2 injektioner af bivalent SARS-CoV-2-vaccine på dag 1 og dag 22	Biologisk: SARS-CoV-2 adjuveret rekombinant proteinvaccine (monovalent B.1.351) (boosterdosis) >= 4 måneder efter sidste vaccination Lægemiddelform: emulsion til injektion. Administrationsvej: intramuskulær injektion. Biologisk: SARS-CoV-2 adjuveret rekombinant proteinvaccine (bivalent D614 + B.1.351) (primær serie) Lægemiddelform: emulsion til injektion. Administrationsvej: intramuskulær injektion.
Placebo komparator: Trin 2: Placebo 2 injektioner af placebo på dag 1 og dag 22	Biologisk: Placebo Lægemiddelform: flydende. Administrationsvej: intramuskulær administration. Biologisk: SARS-CoV-2 adjuveret rekombinant proteinvaccine(monovalent D614)(primær serie)& SARS-CoV-2 adjuveret rekombinant proteinvaccine(monovalent B.1.351)(boosterdosis)>=4 måneder efter sidste vaccination Lægemiddelform: emulsion til injektion. Administrationsvej: intramuskulær injektion.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Stage 1 and Stage 2: Number of Participants With Onset of Symptomatic Coronavirus Disease 2019 (COVID-19) Episode Tidsramme: From Day 36 up to Day 387	Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness (CLI).	From Day 36 up to Day 387
Stage 1 and Stage 2: Number of Participants With Solicited Injection Site and Systemic Reactions Tidsramme: Up to 7 days after each vaccination (post-dose on Days 1 and 22)	A solicited reaction was defined as an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form (CRF) collected within 7 days after each injection and considered to be related to the corresponding study vaccine administered. An injection site reaction was an AR at and around the injection site of the study vaccine. Systemic AR were all ARs that were not injection site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the injection site.	Up to 7 days after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Unsolicited Non-Serious Adverse Events (AEs) Tidsramme: Up to 21 days after each vaccination (post-dose on Days 1 and 22)	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. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that was pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.	Up to 21 days after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Immediate Adverse Events Tidsramme: Up to 30 minutes after each vaccination (post-dose on Days 1 and 22)	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. Immediate events were recorded to capture medically relevant unsolicited injection site and systemic AEs which occurred within the first 30 minutes after vaccination.	Up to 30 minutes after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Medically Attended Adverse Events (MAAE), Serious Adverse Events (SAE), and Adverse Events of Special Interest (AESI) Tidsramme: From first dose of study vaccine administration (Day 1) up to 387 days	An SAE was defined as any AE that at any dose 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, or was an important medical event. An AESI (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.	From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Percentage of Participants With Virologically-Confirmed SARS-CoV-2 Infection and/or Symptomatic COVID-19 Tidsramme: From first dose of study vaccine administration (Day 1) up to 387 days	Virologically-confirmed SARS-CoV-2 infection was defined as a positive result for SARS CoV-2 by nucleic acid amplification test (NAAT) on at least 1 respiratory sample. This included positive results by any NAAT that included tests performed outside the trial protocol if confirmed by the adjudication committee. Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Percentages are rounded off to the tenth decimal place. Here, percentage of participants with virologically-confirmed SARS-CoV-2 infection and/or symptomatic COVID-19 (regardless of adjudication) are reported.	From first dose of study vaccine administration (Day 1) up to 387 days

Sekundære resultatmål

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Dayan GH, Rouphael N, Walsh SR, Chen A, Grunenberg N, Allen M, Antony J, Asante KP, Bhate AS, Beresnev T, Bonaparte MI, Celle M, Ceregido MA, Corey L, Dobrianskyi D, Fu B, Grillet MH, Keshtkar-Jahromi M, Juraska M, Kee JJ, Kibuuka H, Koutsoukos M, Masotti R, Michael NL, Neuzil KM, Reynales H, Robb ML, Villagomez Martinez SM, Sawe F, Schuerman L, Tong T, Treanor J, Wartel TA, Diazgranados CA, Chicz RM, Gurunathan S, Savarino S, Sridhar S; VAT00008 Study Team. Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, parallel, randomised, modified double-blind, placebo-controlled trial. Lancet Respir Med. 2023 Nov;11(11):975-990. doi: 10.1016/S2213-2600(23)00263-1. Epub 2023 Sep 13.

Hjælpsomme links

VAT00008 Plain Language Results Summary

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. maj 2021

Primær færdiggørelse (Faktiske)

31. august 2024

Studieafslutning (Faktiske)

31. august 2024

Datoer for studieregistrering

Først indsendt

26. maj 2021

Først indsendt, der opfyldte QC-kriterier

26. maj 2021

Først opslået (Faktiske)

27. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

VAT00008 (Anden identifikator: Sanofi Identifier)
U1111-1264-3238 (Registry Identifier: ICTRP)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til data på patientniveau og relaterede undersøgelsesdokumenter, herunder den kliniske undersøgelsesrapport, undersøgelsesprotokol med eventuelle ændringer, blank case-rapportformular, statistisk analyseplan og datasætspecifikationer. Data på patientniveau vil blive anonymiseret, og undersøgelsesdokumenter vil blive redigeret for at beskytte forsøgsdeltagernes privatliv. Yderligere detaljer om Sanofis kriterier for datadeling, kvalificerede undersøgelser og proces for at anmode om adgang kan findes på: https://vivli.org

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med COVID-19

Pfizer

Aktiv, ikke rekrutterende

En undersøgelse for at lære om, hvor godt årlige opdateringer til Covid-19-vaccinearbejdet for at beskytte mennesker mod Covid-19, og hvor mange penge folk bruger på sundhedsydelser til Covid-19

COVID-19 | Coronavirus sygdom 2019 (COVID-19) | Covid-19-infektion | Vacciner mod covid-19 | SARS-CoV-2-infektion, COVID19 | COVID-19-vaccination | SARS-CoV-2-infektion, COVID-19 | COVID-19 (Coronavirus sygdom 2019) | COVID-19 SARS-CoV-2-infektion

Forenede Stater
Pfizer

Rekruttering

En undersøgelse af, hvordan Ibuzatrelvir optages i blodet hos raske voksne efter indtagelse af forskellige tabletter af Ibuzatrelvir

Luftvejssygdomme | COVID-19 | Lungebetændelse | Lungesygdomme | Coronavirussygdom 2019 | Coronavirus sygdom 2019 (COVID-19) | Covid-19-infektion | Øvre luftvejsinfektioner | Luftvejsinfektion | COVID-19 (Coronavirus sygdom 2019) | COVID-19 SARS-CoV-2-infektion

Belgien
Shanghai Public Health Clinical Center

Ikke rekrutterer endnu

Sikkerhed og immunogenicitetsvurdering af det rekombinante flagellinproteinadjuvans

COVID-19

Kina
Duke University
National Institute on Minority Health and Health Disparities (NIMHD)

Afsluttet

Du og mig sunde: Test til behandling (YMTT)

COVID-19

Forenede Stater
Eggensberger OHG
Bavarian Health and Food Safety Authority (LGL)

Rekruttering

Effekter af Kneipp-hydroterapi hos post-kovide patienter (HydroCoVitalB)

Tilstand efter COVID-19 | Efter COVID-19 | Post COVID-19 syndrom | Langt COVID-19 syndrom | Post COVID-19 tilstand (PCC)

Tyskland
Yang I. Pachankis

Aktiv, ikke rekrutterende

COVID-19 Vaccination Afgiftning

COVID-19 luftvejsinfektion | COVID-19 stresssyndrom | COVID-19-vaccinebivirkning | COVID-19-associeret tromboembolisme | COVID-19 Post-Intensive Care Syndrome | COVID-19-associeret slagtilfælde

Kina
University of Roma La Sapienza
Queen Mary University of London; Università degli studi di Roma Foro Italico og andre samarbejdspartnere

Afsluttet

Svovlholdigt vandterapi ved virale luftvejssygdomme (STWandRVD)

Postakutte følgesygdomme af COVID-19 | Tilstand efter COVID-19 | Langtids-COVID | Kronisk COVID-19 syndrom

Italien
Lawson Research Institute of St. Joseph's
Canadian Institutes of Health Research (CIHR); Western University, Canada

Rekruttering

Forfølge reduktion i træthed efter COVID-19 via træning og genoptræning (PREFACER): Et randomiseret gennemførlighedsforsøg (PREFACER)

Træthed | Post-COVID-19 syndrom | Tilstand efter COVID-19 | Post-COVID syndrom | Lang COVID-19 | Langtids-COVID | Post-COVID tilstand

Canada
University of Missouri, Kansas City
National Institute on Minority Health and Health Disparities (NIMHD)

Aktiv, ikke rekrutterende

COVID-19 Hurtig Test-til-Behandling Med Afroamerikanske Kirker (Trofast Respons II) (FRII)

Covid-19 testadfærd

Forenede Stater
RSUP Persahabatan

Afsluttet

Inspiratorisk muskelpres og diafragmastyrke hos kvinder med Long COVID-19: Et studie med trykbiofeedback-vejledet træning

Post COVID-19 syndrom | Langt COVID-19 syndrom | Post COVID-syndrom Long Covid

Indonesien

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Stage 1 and Stage 2: Number of Participants With SARS-CoV-2 Infection Tidsramme: From Day 36 up to Day 387	SARS-CoV-2 infection was defined as a serologically-confirmed SARS-CoV-2 infection or virologically-confirmed SARS-CoV-2 infection.	From Day 36 up to Day 387
Stage 1 and Stage 2: Number of Participants With Occurrence of Severe COVID-19 Tidsramme: From Day 36 up to Day 387	Severe COVID-19 was defined as COVID-19 with any 1 of the following: Any clinical signs of severe illness measured at least on 2 occasions separated by 30 minutes. Supplemental oxygen administration for > 1 hour. Use of invasive or non-invasive ventilation or extracorporeal membrane oxygenation. Clinical diagnosis of respiratory failure. Significant acute renal, hepatic, or neurologic dysfunction. Shock. Admission to an intensive care unit. Death.	From Day 36 up to Day 387
Stage 1 and Stage 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection Tidsramme: From first dose of study vaccine administration (Day 1) up to 387 days	Asymptomatic SARS-CoV-2 infection was defined as SARS-CoV-2 infection, with no reported COVID-19-like illness episodes between enrollment and 14 days after the timepoint at which SARS-CoV-2 infection was ascertained.	From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Swabs With Positive Nucleic Acid Amplification Test (NAAT) Tidsramme: From first dose of study vaccine administration (Day 1) up to 387 days	The viral copies were collected as protocol-defined respiratory swabs during participant's illness episode and reported as positive continuous values. Here, duration between two consecutive positive NAAT results was calculated as: (the date of last swab tested positive) - (the date of first tested positive) + 1.	From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Respective Number of Days Between Two Consecutive Positive Nucleic Acid Amplification Test Tidsramme: From first dose of study vaccine administration (Day 1) up to 387 days	Duration between two consecutive positive NAAT results was calculated as: the date of last swab tested positive - the date of first swab tested positive + 1.	From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Positive NAAT for SARS-CoV-2 Tidsramme: From first dose of study vaccine administration (Day 1) up to 387 days	Virologically-confirmed SARS-CoV-2 infection was defined as a positive result for SARS-CoV-2 by NAAT on at least 1 respiratory sample. Respiratory samples for NAAT testing were collected in participants with CLI through the study.	From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Centers for Disease Control and Prevention (CDC)-Defined COVID-19 Tidsramme: From first dose of study vaccine administration (Day 1) up to 387 days	CDC-defined COVID-19 included virologically-confirmed SARS-CoV-2 infection with at least 1 of: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.	From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Occurrences of Hospitalized COVID-19 Tidsramme: From first dose of study vaccine administration (Day 1) up to 387 days	Hospitalized COVID-19 was defined as an episode of symptomatic COVID-19 that required inpatient hospitalization.	From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Symptomatic COVID-19 With Severity of Moderate or Worse Tidsramme: From first dose of study vaccine administration (Day 1) up to 387 days	Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined CLI. Moderate COVID-19 was defined as symptomatic COVID-19 with either shortness of breath that persisted for at least 12 hours or clinical signs of moderate illness measured at least on 2 occasions separated by 30 minutes and no clinical signs indicative of severe COVID-19.	From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, and 43 Tidsramme: Pre-vaccination on Day 1 and post-vaccination on Days 22, and 43	Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.	Pre-vaccination on Day 1 and post-vaccination on Days 22, and 43
Crossover: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G and B.1.351 Strains at Days 1, 43, 142, 163, and 322 Tidsramme: Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163 and 322	Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.	Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163 and 322
Booster: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G and B.1.351 Strains at Days 1, 22, and 202 Tidsramme: Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202	Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.	Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202
Stage 1 and Stage 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22 and 43 Tidsramme: Post-vaccination on Days 22 and 43	Responders are participants who had baseline values below lower limit of quantification (LLOQ) with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.	Post-vaccination on Days 22 and 43
Crossover: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 43, 142, 163, and 322 Tidsramme: Post-vaccination on Days 43, 142, 163 and 322	Responders are participants who had baseline values below LLOQ with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.	Post-vaccination on Days 43, 142, 163 and 322
Booster: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 22 and 202 Tidsramme: Post-vaccination on Days 22, and 202	Responders are participants who had baseline values below LLOQ with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.	Post-vaccination on Days 22, and 202
Stage 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22 and 43 Tidsramme: Pre-vaccination on Day 1 and post-vaccination on Days 22 and 43	Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) are reported.	Pre-vaccination on Day 1 and post-vaccination on Days 22 and 43
Crossover: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 43, 142, 163, and 322 Tidsramme: Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163, and 322	Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) are reported.	Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163, and 322
Booster: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 22 and 202 Tidsramme: Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202	Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) are reported.	Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202
Number of Participants With Symptomatic COVID-19 Episodes Tidsramme: Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487	Symptomatic COVID-19 is defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined CLI. Grade 1: A type of AE that was usually transient and required only minimal treatment or therapeutic intervention and did not generally interfere with usual activities of daily living. Grade 2: A type of AE that was usually alleviated with additional therapeutic intervention and interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the research participant. Grade 3: A type of AE that interrupted usual activities of daily living, or significantly affects clinical status, or required intensive therapeutic intervention.	Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Number of Participants With COVID-19 Severity Using a 7-Point Ordinal Scale Tidsramme: Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487	The COVID-19 severity scale was based on the 7-point ordinal scale of clinical assessments: 1: death; 2: hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 3: hospitalized, on non-invasive ventilation or high flow oxygen devices; 4: hospitalized, that required supplemental oxygen; 5: hospitalized, that did not require supplemental oxygen- discharged but required ongoing medical care (COVID-19 related or otherwise); 6: hospitalized, that did not require supplemental oxygen discharged without ongoing medical care; 7: not hospitalized.	Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Number of Deaths Associated With COVID-19 Tidsramme: Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487	Death associated with COVID-19 was defined as death in a participant with COVID-19 who died within 28 days of the first positive specimen date or who died more than 28 days after the first specimen date and COVID-19 was mentioned as an immediate or underlying cause of death on the death certificate.	Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487

Undersøgelse af monovalente og bivalente rekombinante proteinvacciner mod COVID-19 hos voksne 18 år og ældre (VAT00008)

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Publikationer og nyttige links

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

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

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

produkt fremstillet i og eksporteret fra U.S.A.

Kliniske forsøg med COVID-19

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Taiwan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer