Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients
29. april 2019 opdateret af: Natasha Halasa, Vanderbilt University
Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High Dose Trivalent Inactivated Influenza Vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia
This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.
Studieoversigt
Status
Afsluttet
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Monroe Carell Jr. Children's Hospital at Vanderbilt
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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
3 år til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia.
- Must be in 1st complete remission.
- Must be 4 weeks into maintenance therapy.
- 17 years of age, inclusive.
- Available for duration of study.
Exclusion Criteria:
- History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein.
- History of Guillain-Barre syndrome.
- Evidence of relapsed disease.
- Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
- Have any condition that the investigator believes may interfere with successful completion of the study.
- History of receiving 2010 - 2011 influenza vaccine.
- Pregnant female.
- History of proven influenza disease after September 1, 2010.
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
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: High-Dose trivalent inactivated influenza vaccine
0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.
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0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.
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Aktiv komparator: Standard dose trivalent inactivated influenza vaccine
0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine
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0.5 mL standard dose trivalent inactivated influenza vaccine
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Local Reactions After Each Vaccination
Tidsramme: From baseline to 7 days after each vaccination
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Number of participants with local reactions after each vaccination
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From baseline to 7 days after each vaccination
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Systemic Reaction
Tidsramme: From baseline to 7 days after each vaccination
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Number of participants with systemic reactions after each vaccination
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From baseline to 7 days after each vaccination
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise
Tidsramme: About 6 months after last dose of vaccine.
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Greater than or equal to a Fourfold titer rise three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)
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About 6 months after last dose of vaccine.
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Immunogenicity:Number of Participants With a Pre-titer ≥1:40
Tidsramme: About 6 months after last dose of vaccine.
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Pre-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)
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About 6 months after last dose of vaccine.
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Immunogenicity: Number of Participants With a Post-titer ≥1:40
Tidsramme: About 6 months after last dose of vaccine.
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Post-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)
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About 6 months after last dose of vaccine.
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Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants
Tidsramme: baseline
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Geometric mean titers pre-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)
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baseline
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Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants
Tidsramme: About 6 months after last dose of vaccine.
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Geometric mean titers post-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)
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About 6 months after last dose of vaccine.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Natasha Halasa, M.D., Vanderbilt Universtiy Medical Center
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
1. oktober 2010
Primær færdiggørelse (Faktiske)
1. maj 2013
Studieafslutning (Faktiske)
1. maj 2013
Datoer for studieregistrering
Først indsendt
5. oktober 2010
Først indsendt, der opfyldte QC-kriterier
5. oktober 2010
Først opslået (Skøn)
7. oktober 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. maj 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VICC PED 1067
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med High-dose trivalent inactivated influenza vaccine
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Sanofi Pasteur, a Sanofi CompanyAktiv, ikke rekrutterendeInfluenza | Sunde frivilligeAustralien, Forenede Stater