Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old
16 septembre 2015 mis à jour par: 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Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
1893
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Buenos Aires, Argentine
- Site 2: C1425AWK
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Cordoba, Argentine
- Site 1: X5000BJH
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
3 ans à 64 ans (Enfant, Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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);
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age
Délai: 7 days after vaccination
|
Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.
|
7 days after vaccination
|
|
Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2007
Achèvement primaire (Réel)
1 juillet 2007
Achèvement de l'étude (Réel)
1 décembre 2007
Dates d'inscription aux études
Première soumission
23 avril 2007
Première soumission répondant aux critères de contrôle qualité
23 avril 2007
Première publication (Estimation)
24 avril 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
1 octobre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 septembre 2015
Dernière vérification
1 septembre 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- V71P5
- IND: 13299
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