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Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate

9 mai 2018 mis à jour par: GlaxoSmithKline

A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ (GlaxoSmithKline Biologicals) Administered Intramuscularly in Elderly Aged 60 Years and Older.

The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

150

Phase

  • Phase 2

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

  • Belgique
      • Gent, Belgique, 9000
        • GSK Investigational Site

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

60 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
  • A male or female 60 years or older at the time of the first vaccination.
  • Free of obvious health problems

Exclusion Criteria:

  • Use of non-registered products
  • Administration of immune-modifying drugs.
  • Administration of vaccine 30 days before enrolment in study.
  • Immunosuppressive or immunodeficient condition.
  • Hypersensitivity to a previous dose of influenza vaccine
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
  • History of confirmed influenza infection within the last 12 Months.
  • Acute disease at the time of enrolment/vaccination.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine

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: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: GSK1247446A Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biologique: GSK1247446A Group
Low dose influenza vaccine adjuvanted with AS03 compared
Autres noms:
  • Low dose adjuvanted influenza vaccine
Comparateur actif: Fluarix Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biologique: Fluarix™
GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Délai: At Days 0 and 21
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
At Days 0 and 21
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Délai: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
At Day 21
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
Délai: At Day 0 and Day 21
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
At Day 0 and Day 21
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Délai: At Day 21
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
At Day 21

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Délai: At Days 0 and 21
The geometric mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).
At Days 0 and 21
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
Délai: At Days 0 and 21
The geometric mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).
At Days 0 and 21
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Délai: During the 7-day (Days 0-6) post-vaccination period
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were considered to be related to vaccination.
During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Délai: During the 7-day (Days 0-6) post-vaccination period
Assessed solicited general symptoms were arthralgia, fatigue, fever [axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Délai: During the 30-day (Days 0-29) post vaccination period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination.
During the 30-day (Days 0-29) post vaccination period
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Délai: During the entire study period (from Day 0 to Day 29)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE considered by the investigator to have a causal relationship to study vaccination.
During the entire study period (from Day 0 to Day 29)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

GlaxoSmithKline

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.

Liens utiles

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

2 octobre 2006

Achèvement primaire (Réel)

1 novembre 2006

Achèvement de l'étude (Réel)

17 novembre 2006

Dates d'inscription aux études

Première soumission

7 août 2006

Première soumission répondant aux critères de contrôle qualité

11 août 2006

Première publication (Estimation)

15 août 2006

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 juin 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 mai 2018

Dernière vérification

1 octobre 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 107975

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Données/documents d'étude

  1. Formulaire de consentement éclairé
    Identifiant des informations: 107975
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  2. Ensemble de données de participant individuel
    Identifiant des informations: 107975
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protocole d'étude
    Identifiant des informations: 107975
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  4. Rapport d'étude clinique
    Identifiant des informations: 107975
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  5. Spécification du jeu de données
    Identifiant des informations: 107975
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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