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Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above

28 mai 2018 mis à jour par: GlaxoSmithKline

A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older

Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This study has 2 phases:

The study ID 107064 corresponds to objectives & outcome measures evaluated from day 0 until day 51.

The study ID 107217 corresponds to objectives & outcome measures evaluated at day 180.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Type d'étude

Interventionnel

Inscription (Réel)

5075

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

  • Allemagne
      • Berlin, Allemagne, 14057
        • GSK Investigational Site
      • Berlin, Allemagne, 10117
        • GSK Investigational Site
      • Berlin, Allemagne, 10787
        • GSK Investigational Site
      • Hamburg, Allemagne, 22143
        • GSK Investigational Site
      • Hamburg, Allemagne, 20249
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Allemagne, 81667
        • GSK Investigational Site
      • Muenchen, Bayern, Allemagne, 80799
        • GSK Investigational Site
      • Regensburg, Bayern, Allemagne, 93053
        • GSK Investigational Site
      • Wuerzburg, Bayern, Allemagne, 97070
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Allemagne, 19055
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Allemagne, 30519
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Witten, Nordrhein-Westfalen, Allemagne, 58455
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Allemagne, 01067
        • GSK Investigational Site
      • Leipzig, Sachsen, Allemagne, 04229
        • GSK Investigational Site
      • Leipzig, Sachsen, Allemagne, 04103
        • GSK Investigational Site
  • Espagne
      • Barcelona, Espagne, 08036
        • GSK Investigational Site
      • Barcelona, Espagne, 08035
        • GSK Investigational Site
      • Madrid, Espagne, 28041
        • GSK Investigational Site
      • Madrid, Espagne, 28006
        • GSK Investigational Site
      • Madrid, Espagne, 28040
        • GSK Investigational Site
      • Marid, Espagne, 28040
        • GSK Investigational Site
      • Valencia, Espagne, 46017
        • GSK Investigational Site
      • Valencia, Espagne, 46014
        • GSK Investigational Site
  • Estonie
      • Tallinn, Estonie, 10617
        • GSK Investigational Site
      • Tartu, Estonie, 50417
        • GSK Investigational Site
  • France
      • Caen cedex 4, France, 14052
        • GSK Investigational Site
      • Lagord, France, 17140
        • GSK Investigational Site
      • Nantes, France, 44093
        • GSK Investigational Site
      • Paris Cedex 18, France, 75877
        • GSK Investigational Site
      • Poitiers, France, 86000
        • GSK Investigational Site
      • Rouen, France, 76100
        • GSK Investigational Site
  • Fédération Russe
      • Ekaterinburg, Fédération Russe, 620078
        • GSK Investigational Site
      • Ekaterinburg, Fédération Russe, 620028
        • GSK Investigational Site
      • Kazan, Fédération Russe, 420015
        • GSK Investigational Site
      • Novokuznetsk, Fédération Russe, 654063
        • GSK Investigational Site
      • Saratov, Fédération Russe
        • GSK Investigational Site
  • Pays-Bas
      • Rotterdam, Pays-Bas, 3011 EN
        • GSK Investigational Site
      • Rotterdam, Pays-Bas, 3015 GE
        • GSK Investigational Site
  • Suède
      • Eskilstuna, Suède, SE-631 88
        • GSK Investigational Site
      • Stockholm, Suède, SE-141 86
        • 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

18 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 will comply with the requirements of the protocol.
  • A male or female aged 18 years or above at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential, for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

  • Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination.
  • Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual interpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first administration of the study vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • History of chronic alcohol consumption and/or drug abuse.
  • History of hypersensitivity to vaccines.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Major congenital defects or serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included).
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the study vaccine or during the study.
  • Lactating women
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.

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: GSK1562902A Group
Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses.
Biologique: Adjuvanted pandemic influenza candidate vaccine
2 doses, intramuscular injection
Comparateur actif: Fluarix+Placebo Group
Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses.
Biologique: Fluarix
One intramuscular injection
Biologique: Placebo
One intramuscular injection

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Subjects With Solicited Local Symptoms
Délai: During a 7 day follow-up period after each dose of vaccine and overall.
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter
During a 7 day follow-up period after each dose of vaccine and overall.
Number of Subjects With Solicited General Symptoms (Dose 1)
Délai: During the 7-day (Days 0-6) after Dose 1
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
During the 7-day (Days 0-6) after Dose 1
Number of Subjects With Solicited General Symptoms (Dose 2)
Délai: During the 7-day (Days 0-6) after Dose 2
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
During the 7-day (Days 0-6) after Dose 2
Number of Subjects With Solicited General Symptoms (Across Doses)
Délai: During the 7-day (Days 0-6) post vaccination across dosses
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
During the 7-day (Days 0-6) post vaccination across dosses
Number of Subjects With Unsolicited Adverse Events (AEs)
Délai: During the 21st Day (Days 0-20) post Dose 1
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.
During the 21st Day (Days 0-20) post Dose 1
Number of Subjects With AEs
Délai: During the 30 Day (Days 0-29) post Dose 2
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.
During the 30 Day (Days 0-29) post Dose 2
Number of Subjects With Serious Adverse Events (SAEs)
Délai: From Day 0 to Day 180
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
From Day 0 to Day 180
Number of Subjects With New Onset Chronic Diseases (NOCDs)
Délai: From Day 0 to Day 180
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
From Day 0 to Day 180
Number of Subjects With Medically Significant Conditions (MSCs)
Délai: From Day 0 to Day 51
MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
From Day 0 to Day 51

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1
Délai: At Day 0 (PRE), 21 and 42
Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).
At Day 0 (PRE), 21 and 42
Number of Seroconverted Subjects Against H5N1
Délai: At Day 21 and Day 42
Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.
At Day 21 and Day 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain
Délai: At Day 21 and Day 42
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.
At Day 21 and Day 42
Number of Seroprotected Subjects Against A/Vietnam Influenza Strain
Délai: At Day 0 (PRE), Day 21 and Day 42
Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
At Day 0 (PRE), Day 21 and Day 42

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.

Publications générales

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 (Réel)

1 mai 2006

Achèvement primaire (Réel)

1 janvier 2007

Achèvement de l'étude (Réel)

31 juillet 2007

Dates d'inscription aux études

Première soumission

26 avril 2006

Première soumission répondant aux critères de contrôle qualité

26 avril 2006

Première publication (Estimation)

27 avril 2006

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juillet 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 mai 2018

Dernière vérification

1 avril 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 107064
  • 107217 (Autre identifiant: GSK)

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: 107064
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  2. Spécification du jeu de données
    Identifiant des informations: 107064
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protocole d'étude
    Identifiant des informations: 107064
    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: 107064
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  5. Ensemble de données de participant individuel
    Identifiant des informations: 107064
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 107064 are summarised with study 107217 on the GSK Clinical Study Register.
  6. Plan d'analyse statistique
    Identifiant des informations: 107064
    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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