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Fase 2-studie av VLA15, en vaksinekandidat mot Lyme Borreliosis, i en sunn studiepopulasjon for pediatrisk og voksen

19. august 2026 oppdatert av: Pfizer

Sikkerhets- og immunogenisitetsstudie av VLA15, en multivalent rekombinant OspA-basert vaksinekandidat mot Lyme Borreliosis: En randomisert, kontrollert, observatørblind fase 2-studie i en sunn pediatrisk og voksen studiepopulasjon

VLA15-221 er en fase 2-studie, som vil bli gjennomført i to deler: Hovedstudiefase (del A) og boosterfase (del B). Studien vil sammenligne sikkerheten og immunogenisiteten til to forskjellige primærimmuniseringsplaner med tre (måned 0-2-6) eller to (måned 0-6) vaksinasjoner. Innenfor studien vil 600 friske forsøkspersoner i alderen 5-65 år inkluderes. Personer med en historie med Lyme-borreliose (tidligere infeksjon med Borrelia) samt Borrelia-naive forsøkspersoner vil bli registrert. Studievarighet per emne vil være maksimalt 19 måneder i del A og ytterligere 37 måneder for emner som er registrert i del B.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

VLA15-221 er en randomisert, observatørblind, placebokontrollert, multisenter fase 2-studie, som er satt opp i to deler: Hovedstudiefase (del A) og boosterfase (del B). I del A vil 600 forsøkspersoner i alderen 5-65 år bli registrert 1:1:1 i tre grupper: Gruppe 1 vil bli vaksinert med VLA15 ved måned 0-2-6, gruppe 2 vil bli vaksinert med VLA15 ved måned 0-6 og med placebo ved måned 2 og gruppe 3 vil bli vaksinert med placebo ved måned 0-2-6. I del B vil en undergruppe av forsøkspersoner motta en boosterinjeksjon med VLA15 eller placebo ved måned 18.

Studietype

Intervensjonell

Registrering (Faktiske)

625

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Connecticut
      • Bridgeport, Connecticut, Forente stater, 06606
        • New England Research Associates
      • Stamford, Connecticut, Forente stater, 06905
        • Stamford Therapeutics Consortium
      • Waterbury, Connecticut, Forente stater, 06708
        • Chase Medical Research, LLC
      • Waterbury, Connecticut, Forente stater, 06708
        • Pediatric Associates of Conn. PC
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55402
        • Clinical Research Institute, Inc.
    • New Jersey
      • East Orange, New Jersey, Forente stater, 07018
        • Foundation Pediatrics
      • Irvington, New Jersey, Forente stater, 07111
        • Med Clinical Research Partners, LLC
    • New York
      • Binghamton, New York, Forente stater, 13905
        • Meridian Clinical Research LLC
      • Rochester, New York, Forente stater, 14609
        • Rochester Clinical Research, Inc.
      • Staten Island, New York, Forente stater, 10314
        • Richmond Behavioral Associates
      • The Bronx, New York, Forente stater, 10467
        • Advantage Clinical Trials
    • Ohio
      • Cleveland, Ohio, Forente stater, 44122
        • Velocity Clinical Research, Inc.
    • Pennsylvania
      • Erie, Pennsylvania, Forente stater, 16506
        • Allegheny Health and Wellness Pavilion
      • Erie, Pennsylvania, Forente stater, 16508
        • Liberty Family Practice
      • Fort Washington, Pennsylvania, Forente stater, 19034
        • Lockman & Lubell Pediatric Associates
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, Forente stater, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, Forente stater, 02903
        • Hasbro Children's Hospital
      • Warwick, Rhode Island, Forente stater, 02886
        • Velocity Clinical Research Providence

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

5 år til 65 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Beskrivelse

Inklusjonskriterier:

  • Forsøkspersonen er i alderen 5 til 65 år på screeningsdagen (besøk 0)
  • Emnet har god generell helse

  • Foreldre/juridisk representant(er) og forsøksperson forstår studien og dens prosedyrer, godtar bestemmelsene

    • for personer i alderen 18-65 år: skriftlig informert samtykke før eventuelle studierelaterte prosedyrer
    • for forsøkspersoner i alderen 5-17 år: skriftlig informert samtykke fra forsøkspersonens juridiske representant(er), i henhold til lokale krav, og skriftlig informert samtykke fra emnet, hvis aktuelt, før eventuelle studierelaterte prosedyrer.

  • Hvis forsøkspersonen er i fertil alder: Forsøkspersonen har en negativ serumgraviditetstest ved screening (besøk 0) og samtykker i å bruke tilstrekkelige prevensjonstiltak i henhold til følgende tidslinjer:

    • Hovedstudiefase: varighet av hele studien
    • Boosterfase: til måned 23 (dvs. 5 måneder etter boosterdose)
  • Forsøkspersonen er villig og i stand til å overholde planlagte besøk, behandlingsplan og andre studieprosedyrer
  • Emnet er tilgjengelig under studiens varighet og kan kontaktes på telefon under studiedeltakelsen

Ekskluderingskriterier:

  • Personen har en kronisk sykdom relatert til Lyme borreliose (LB), en aktiv symptomatisk LB, eller mottatt behandling for LB i løpet av de siste 3 månedene før dag 1;
  • Personen fikk tidligere vaksinasjon mot LB;
  • Personen hadde et flåttbitt innen 4 uker før dag 1;
  • Personen har en sykehistorie med eller har for tiden en klinisk relevant sykdom;
  • Personen har en medisinsk historie med eller har for tiden en nevroinflammatorisk eller autoimmun sykdom;
  • Personen har en kjent trombocytopeni, blødningsforstyrrelse eller mottok antikoagulantia i løpet av de 3 ukene før dag 1;
  • Personen har mottatt en aktiv eller passiv immunisering innen 4 uker før dag 1;
  • Forsøkspersonen har mottatt et annet registrert eller ikke-registrert legemiddel i en annen klinisk utprøving innen 4 uker før vaksinasjon på dag 1;
  • Personen har en kjent eller mistenkt defekt i immunsystemet eller mottok immunsuppressiv behandling innen 4 uker før dag 1;
  • Personen har en historie med anafylaksi av ukjent årsak eller alvorlige allergiske reaksjoner av ukjent årsak eller har en kjent overfølsomhet eller allergiske reaksjoner mot en av komponentene i vaksinen;
  • Personen har hatt malignitet de siste 5 årene;
  • Forsøkspersonen er gravid, har planer om å bli gravid i løpet av studiet eller ammer ved påmelding;
  • Personen har donert eller planlegger å donere blod eller blodavledede produkter 4 uker før dag 1;
  • Forsøkspersonen har en tilstand som kan kompromittere dets velvære, kan forstyrre evalueringen av studiens endepunkter, eller som vil begrense forsøkspersonens evne til å fullføre studien;
  • Subjektet er i et avhengighetsforhold;

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Del A+B – Gruppe 1
Del A: VLA15 ved måned 0, 2 og 6. Del B: VLA15 ved måned 18, 30 og 42
Biologisk: VLA15
en multivalent rekombinant Outer Surface Protein A (OspA) basert vaksinekandidat
Eksperimentell: Del A+B – Gruppe 2
Del A: VLA15 ved måned 0 og 6, placebo ved måned 2 Del B: VLA15 ved måned 18, 30 og 42
Biologisk: VLA15
en multivalent rekombinant Outer Surface Protein A (OspA) basert vaksinekandidat
Biologisk: Placebo
PBS (fosfatbufret saltvann)
Placebo komparator: Del A+B – Gruppe 3
Del A: Placebo ved måned 0, 2 og 6 Del B: Placebo ved måned 18, 30 og 42
Biologisk: Placebo
PBS (fosfatbufret saltvann)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Tidsramme: From Day 1 to Day 7 after vaccination 1 at Month 0
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness meeting grading scale (MGS), swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 1 at Month 0
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Tidsramme: From Day 1 to Day 7 after vaccination 2 at Month 2
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 2 at Month 2
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Tidsramme: From Day 1 to Day 7 after vaccination 3 at Month 6
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 3 at Month 6
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Tidsramme: From Day 1 to Day 7 after any vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after any vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
Tidsramme: At Day 208 (Month 7)
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 was presented in this outcome measure.
At Day 208 (Month 7)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 1 Booster Dose
Tidsramme: From Day 1 to Day 7 after vaccination 1 booster dose at Month 18
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 1 booster dose at Month 18
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 Booster Dose
Tidsramme: From Day 1 to Day 7 after vaccination 2 booster dose at Month 30
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 2 booster dose at Month 30
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 Booster Dose
Tidsramme: From Day 1 to Day 7 after vaccination 3 booster dose at Month 42
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 3 booster dose at Month 42
Percentage of Participants With Serious Adverse Events (SAEs)
Tidsramme: From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)
A SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition.
From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Tidsramme: From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)
An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor were appropriate.
From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)
Percentage of Participants With Unsolicited AE
Tidsramme: Up to 28 Days after vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively, and up to 28 Days after vaccination 1, 2 or 3 booster dose at Month 18, 30 and 42, respectively
An AE was any untoward medical occurrence in a participant administered an investigational product, whether or not related to this treatment. Unsolicited AEs were defined as any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event.
Up to 28 Days after vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively, and up to 28 Days after vaccination 1, 2 or 3 booster dose at Month 18, 30 and 42, respectively
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
Tidsramme: SAEs & AESIs: From Day 1 of vaccination up to Month 48; Solicited AEs: from Day 1 to Day 7 after vaccination 1, 2, 3, 4, 5 and 6; Unsolicited AEs: up to 28 Days after vaccination 1, 2, 3, 4, 5 and 6
Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs stratified by age group 5-11, 12-17 and 18-65 years were reported. SAE: any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. AESI: scientific and medical concern specific to the sponsor's product or program. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AEs: any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event.
SAEs & AESIs: From Day 1 of vaccination up to Month 48; Solicited AEs: from Day 1 to Day 7 after vaccination 1, 2, 3, 4, 5 and 6; Unsolicited AEs: up to 28 Days after vaccination 1, 2, 3, 4, 5 and 6
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Days 85, 180, 365 and Month 18
Tidsramme: Baseline; Days 85, 180 and 365; Month 18
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay were evaluated.
Baseline; Days 85, 180 and 365; Month 18
Seroconversion Rate (SCR) at Days 85, 180, 208, 365 and Month 18
Tidsramme: Days 85, 180, 208 and 365; Month 18
Seroconversion for enzyme linked immunosorbent assay (ELISA) was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a greater than or equal to (>=) 4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA.
Days 85, 180, 208 and 365; Month 18
Geometric Mean of the Fold Rise (GMFR) for IgG When Compared to Baseline Against Each OspA Serotype (ST1 to ST6) at Days 85 and 208
Tidsramme: Days 85 and 208
GMFR for IgG when compared to baseline against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208 were evaluated.
Days 85 and 208
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Days 85, 180, 194, 365 and Month 18
Tidsramme: Baseline; Days 85, 180, 194 (18 to 65 years only) and 365; Month 18
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (5-11, 12-17 and 18-65 years) were evaluated. Day 194 data was reported for adult participants only as pre-specified in protocol.
Baseline; Days 85, 180, 194 (18 to 65 years only) and 365; Month 18
SCR Stratified by Age Group at Days 85, 180, 194, 208, 365 and Month 18
Tidsramme: Days 85, 180, 194 (18 to 65 years only), 208 and 365; Month 18
Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a >=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA. Day 194 data was reported for adult participants only as pre-specified in protocol.
Days 85, 180, 194 (18 to 65 years only), 208 and 365; Month 18
GMFR for IgG When Compared to Baseline Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Days 85 and 208
Tidsramme: Days 85 and 208
GMFR for IgG when compared to baseline against each OspA serotype ST1 to ST6, stratified by age group (5-11, 12-17 and 18-65 years) determined by IgG binding assay at Day 85 and Day 208 were evaluated.
Days 85 and 208
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Tidsramme: Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay were evaluated.
Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
SCR at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Tidsramme: Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a >=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA.
Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Months 19, 31 and 43 During the Booster Phase
Tidsramme: Months 19, 31 and 43
GMFRs for IgG were determined by IgG binding assay for each OspA serotype (ST1-ST6) at Months 19, 31, and 43 relative to the corresponding pre-booster timepoints Months 18, 30, and 42, respectively.
Months 19, 31 and 43
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Tidsramme: Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (5-11, 12-17 and 18-65 years) were evaluated.
Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
SCR Stratified by Age Group at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Tidsramme: Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a >=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA.
Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Months 19, 31 and 43 During the Booster Phase
Tidsramme: Months 19, 31 and 43
GMFRs for IgG were determined by IgG binding assay for each OspA serotype (ST1-ST6), stratified by age group (5-11, 12-17 and 18-65 years) at Months 19, 31, and 43 relative to the corresponding pre-booster timepoints Months 18, 30, and 42, respectively.
Months 19, 31 and 43

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Samarbeidspartnere

Valneva Austria GmbH

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. mars 2021

Primær fullføring (Faktiske)

25. mars 2022

Studiet fullført (Faktiske)

2. juli 2025

Datoer for studieregistrering

Først innsendt

8. mars 2021

Først innsendt som oppfylte QC-kriteriene

15. mars 2021

Først lagt ut (Faktiske)

17. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VLA15-221
  • C4601008 (Annen identifikator: Alias Study Number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer vil gi tilgang til individuelle avidentifiserte deltakerdata og relaterte studiedokumenter (f.eks. protokoll, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) på forespørsel fra kvalifiserte forskere, og underlagt visse kriterier, betingelser og unntak. Ytterligere detaljer om Pfizers datadelingskriterier og prosess for å be om tilgang finnes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere