Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old
16 september 2015 uppdaterad av: 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Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
1893
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Buenos Aires, Argentina
- Site 2: C1425AWK
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Cordoba, Argentina
- Site 1: X5000BJH
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
3 år till 64 år (Barn, Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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);
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
Tidsram: 21 days after vaccination
|
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%.
|
21 days after vaccination
|
|
Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age
Tidsram: 21 days after 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).
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%.
|
21 days after vaccination
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age
Tidsram: 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.
|
7 days after vaccination
|
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Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age
Tidsram: 21 days after vaccination
|
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
|
|
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age
Tidsram: 21 days after 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 one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
|
21 days after vaccination
|
|
Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age
Tidsram: 21 days after vaccination
|
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.
|
21 days after vaccination
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age
Tidsram: 7 days after vaccination
|
Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.
|
7 days after vaccination
|
|
Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age
Tidsram: 50 days after last vaccination
|
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.
|
50 days after last vaccination
|
|
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age
Tidsram: 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
Tidsram: 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.
Tidsram: 7 days after each vaccination
|
Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.
|
7 days after each vaccination
|
|
Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age
Tidsram: 21 days after vaccination
|
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
|
Samarbetspartners och utredare
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Sponsor
Samarbetspartners
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2007
Primärt slutförande (Faktisk)
1 juli 2007
Avslutad studie (Faktisk)
1 december 2007
Studieregistreringsdatum
Först inskickad
23 april 2007
Först inskickad som uppfyllde QC-kriterierna
23 april 2007
Första postat (Uppskatta)
24 april 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
1 oktober 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 september 2015
Senast verifierad
1 september 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- V71P5
- IND: 13299
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .