Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age
18. november 2014 opdateret af: Novartis Vaccines
A Phase III, Observer Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Chicken Eggs (Fluvirin®), in Healthy Children and Adolescents 4 to 17 Years of Age.
Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2055
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Westmead, New South Wales, Australien, 2145
- 100, Novartis Investigational Site
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Queensland
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Auchenflower, Queensland, Australien, 4066
- 108, Novartis Investigational Site
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Sherwood, Queensland, Australien, 4075
- 107, Novartis Investigational Site
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South Australia
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North Adelaide, South Australia, Australien, 5006
- 104, Novartis Investigational Site
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Victoria
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Carlton, Victoria, Australien, 3010
- 103, Novartis Investigational Site
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Western Australia
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Subiaco, Western Australia, Australien, 6008
- 105, Novartis Investigational Site
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Alabang
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Muntinlupa City, Alabang, Filippinerne, 1781
- 250, Novartis Investigational Site
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Muntinlupa City, Alabang, Filippinerne, 1781
- 251, Novartis Investigational Site
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Muntinlupa City, Alabang, Filippinerne, 1781
- 254, Novartis Investigational Site
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Ermita
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Manila, Ermita, Filippinerne, 1001
- 253, Novartis Investigational Site
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Sampaloc
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Manila, Sampaloc, Filippinerne, 1001
- 252, Novartis Investigation Site
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Alabama
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Mobile, Alabama, Forenede Stater, 36608
- 320, Novartis Investigational Site
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Florida
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Ponte Vedra, Florida, Forenede Stater, 32081
- 312, Novartis Investigational Site
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Kansas
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Augusta, Kansas, Forenede Stater, 67010
- 313, Novartis Investigational Site
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Newton, Kansas, Forenede Stater, 67114
- 305, Novartis Investigational Site
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Wichita, Kansas, Forenede Stater, 67205
- 302, Novartis Investigational Site
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Wichita, Kansas, Forenede Stater, 67207
- 301, Novartis Investigational Site
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Nebraska
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Fremont, Nebraska, Forenede Stater, 68025
- 311, Novartis Investigational Site
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North Carolina
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Winston-salem, North Carolina, Forenede Stater, 27103
- 308, Novartis Investigational Site
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Ohio
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Cleveland, Ohio, Forenede Stater, 44121
- 317, Novartis Investigational Site
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74127
- 309, Novartis Investigational Site
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Rhode Island
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Warwick, Rhode Island, Forenede Stater, 02886
- 314, Novartis Investigational Site
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South Carolina
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Mount Pleasant, South Carolina, Forenede Stater, 29464
- 319, Novartis Investigational Site
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Tennessee
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Bristol, Tennessee, Forenede Stater, 37620
- 310, Novartis Investigational Site
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Nashville, Tennessee, Forenede Stater, 37203
- 318, Novartis Investigational Site
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Utah
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Salt Lake, Utah, Forenede Stater, 84124
- 315, Novartis Investigational Site
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Salt Lake City, Utah, Forenede Stater, 84109
- 304, Novartis Investigational Site
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Salt Lake City, Utah, Forenede Stater, 84121
- 306, Novartis Investigational Site
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South Jordan, Utah, Forenede Stater, 84095
- 303, Novartis Investigational Site
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Auckland
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Takapuna, Auckland, New Zealand, 0622
- 151, Novartis Investigational Site
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Christchurch
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Beckenham, Christchurch, New Zealand, 8024
- 150, Novartis Investigational Site
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Muang
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Khon Kaen, Muang, Thailand, 40002
- 201, Novartis Investigational Site
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Rajathevi
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Bangkok, Rajathevi, Thailand, 10400
- 200, Novartis Investigational Site
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Siriraj
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Bangkoknoi, Siriraj, Thailand, 10700
- 202, Novartis Investigational Site
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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
4 år til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy subjects 4-17 years of age
Exclusion Criteria:
- Subjects who are not healthy,
- Subjects who are pregnant or breast feeding,
- Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: TIVc
Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
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Aktiv komparator: TIVf
Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.
Tidsramme: Day 1 to Day 7 after any vaccination
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Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
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Day 1 to Day 7 after any vaccination
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Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Tidsramme: Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.
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Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
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Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.
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Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.
Tidsramme: Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects
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Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.
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Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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. maj 2013
Primær færdiggørelse (Faktiske)
1. juni 2014
Studieafslutning (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først indsendt
16. maj 2013
Først indsendt, der opfyldte QC-kriterier
17. maj 2013
Først opslået (Skøn)
20. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. november 2014
Sidst verificeret
1. november 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- V58_31
- U1111-1139-9440 (Anden identifikator: Universal Trial Number (UTN))
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 .