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- Klinische proef NCT00464672
Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old
16 september 2015 bijgewerkt door: Novartis
A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Immunogenicity of Two Trivalent Subunit Inactivated Influenza Vaccines in Healthy Children Aged 3 to 8 Years, in Healthy Children/Adolescents Aged 9 to 17 Years,and in Healthy Adults Aged 18 to 64 Years
This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US.
The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1893
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Buenos Aires, Argentinië
- Site 2: C1425AWK
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Cordoba, Argentinië
- Site 1: X5000BJH
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
3 jaar tot 64 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Healthy subjects 3 to 64 years of age
Exclusion Criteria:
- Receipt of other investigational products within 3 months or other vacine within 1 month;
- Allergy to eggs, egg products, or any other vaccine component;
- Laboratory confirmed influenza disease within 6 months;
- Have previously received an influenza vaccination (3 to 8 years only);
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Influenza virus vaccine
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Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
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Actieve vergelijker: Comparator influenza vaccine
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Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
Tijdsspanne: 21 days after vaccination
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To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age.
The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.
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21 days after vaccination
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Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age
Tijdsspanne: 21 days after vaccination
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Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase).
According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.
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21 days after vaccination
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age
Tijdsspanne: 7 days after vaccination
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Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.
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7 days after vaccination
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Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age
Tijdsspanne: 21 days after vaccination
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To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
|
21 days after vaccination
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Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age
Tijdsspanne: 21 days after vaccination
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Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
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21 days after vaccination
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Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age
Tijdsspanne: 21 days after vaccination
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To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
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21 days after vaccination
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Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age
Tijdsspanne: 7 days after vaccination
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Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.
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7 days after vaccination
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Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age
Tijdsspanne: 50 days after last vaccination
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To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
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50 days after last vaccination
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Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age
Tijdsspanne: 50 days after last vaccination
|
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
|
50 days after last vaccination
|
Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age
Tijdsspanne: 50 days after last vaccination
|
To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
|
50 days after last vaccination
|
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.
Tijdsspanne: 7 days after each vaccination
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Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.
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7 days after each vaccination
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Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age
Tijdsspanne: 21 days after vaccination
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Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.
|
21 days after vaccination
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2007
Primaire voltooiing (Werkelijk)
1 juli 2007
Studie voltooiing (Werkelijk)
1 december 2007
Studieregistratiedata
Eerst ingediend
23 april 2007
Eerst ingediend dat voldeed aan de QC-criteria
23 april 2007
Eerst geplaatst (Schatting)
24 april 2007
Updates van studierecords
Laatste update geplaatst (Schatting)
1 oktober 2015
Laatste update ingediend die voldeed aan QC-criteria
16 september 2015
Laatst geverifieerd
1 september 2015
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- V71P5
- IND: 13299
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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