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Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)

31 juillet 2018 mis à jour par: GlaxoSmithKline

Immunogenicity and Safety Study of GSK Biologicals' Influenza Candidate Vaccine GSK2340274A

This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

This Protocol Posting has been updated following Protocol amendment 1& 2, October 2009. The sections impacted are study design and outcome measures

Type d'étude

Interventionnel

Inscription (Réel)

100

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

      • Fukuoka, Japon, 813-8588
        • GSK Investigational Site
      • Tokyo, Japon, 204-8585
        • 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

20 ans à 64 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive.
  • Good general health as assessed by medical history and physical examination
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
  • Females of non-childbearing potential may be enrolled in the study.
  • Female of childbearing potential may be enrolled in the study, if she:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • History of previous administration of a novel [H1N1]v vaccine.
  • Previous participation in study NCT00742885.
  • Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
  • Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Presence of an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • Diagnosed with cancer, or treatment for cancer within 3 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
  • Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
  • Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome.
  • Administration of any vaccines within 30 days before vaccination or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182, with the exception of seasonal influenza vaccine.
  • Administration of any seasonal influenza vaccine within 14 days before vaccination on Day 0, or planned administration within the first vaccination up to blood sampling at Day 42 and within 14 days prior to blood sampling at Day 182.
  • Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known pregnancy or a positive urine test result prior to the time of first vaccination.
  • Lactating or nursing female.
  • Excessive underweight (Body Mass Index [BMI] < 18.5) or excessive obesity (BMI >= 30).
  • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start.

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: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: GSK2340274A GROUP
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Two intramuscular injections on Day 0 and Day 21, respectively

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Day 0
Titers are presented as geometric mean titers (GMTs).
At Day 0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Day 21
Titers are presented as geometric mean titers (GMTs).
At Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Day 42
Titers are presented as geometric mean titers (GMTs).
At Day 42
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
Délai: At Day 0
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
At Day 0
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Day 21
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
At Day 21
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Day 42
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
At Day 42
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller 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 four-fold increase in post-vaccination titer.
At Day 21
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Day 42
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller 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 four-fold increase in post-vaccination titer.
At Day 42
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Day 0
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
At Day 0
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Day 21
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
At Day 21
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Day 42
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
At Day 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
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.
At Day 21
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Day 42
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.
At Day 42

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
Délai: At Days 0, 21, 42 and 182
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
At Days 0, 21, 42 and 182
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Days 0, 21, 42 and 182
Titers are presented as geometric mean titers (GMTs).
At Days 0, 21, 42 and 182
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Days 21, 42 and 182
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller 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 four-fold increase in post-vaccination titer.
At Days 21, 42 and 182
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Days 0, 21, 42 and 182
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
At Days 0, 21, 42 and 182
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Délai: At Days 21, 42 and 182
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.
At Days 21, 42 and 182
Titers for Serum Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Délai: At Days 0, 21, 42 and 182
Titers are presented as geometric mean titers (GMTs).
At Days 0, 21, 42 and 182
Number of Seropositive Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Délai: At Days 0, 21, 42 and 182
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:8.
At Days 0, 21, 42 and 182
Number of Seroconverted Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Délai: At Days 21, 42 and 182
A seroconverted subject was defined as a vaccinated subject with a minimum 4-fold increase in post vaccination neutralizing titer.
At Days 21, 42 and 182
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Délai: During a 7-day (Days 0-6) follow-up after each vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
During a 7-day (Days 0-6) follow-up after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Délai: During a 7-day (Days 0-6) follow-up after each vaccination
Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
During a 7-day (Days 0-6) follow-up after each vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Délai: During a 21-day (Days 0-20) follow-up period after the first vaccination and during a 63-day (Days 21-84) follow-up after the second vaccination
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.
During a 21-day (Days 0-20) follow-up period after the first vaccination and during a 63-day (Days 21-84) follow-up after the second vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Délai: During the entire study period (Days 0-182)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
During the entire study period (Days 0-182)
Number of Subjects With Any Adverse Events of Specific Interest (AESIs).
Délai: During the entire study period (Days 0-182)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
During the entire study period (Days 0-182)
Number of Days With Any Solicited Local Symptoms
Délai: During a 7-day (Days 0-6) follow-up after each vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited local symptom was assessed in subjects who have reported at least once the symptom.
During a 7-day (Days 0-6) follow-up after each vaccination
Number of Days With Any Solicited General Symptoms
Délai: During a 7-day (Days 0-6) follow-up after each vaccination
Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited general symptom was assessed in subjects who have reported at least once the symptom.
During a 7-day (Days 0-6) follow-up after each vaccination

Collaborateurs et enquêteurs

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

Parrainer

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 octobre 2009

Achèvement primaire (Réel)

19 avril 2010

Achèvement de l'étude (Réel)

19 avril 2010

Dates d'inscription aux études

Première soumission

1 octobre 2009

Première soumission répondant aux critères de contrôle qualité

1 octobre 2009

Première publication (Estimation)

5 octobre 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 janvier 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 juillet 2018

Dernière vérification

1 avril 2017

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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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. Rapport d'étude clinique
    Identifiant des informations: 113519
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  2. Plan d'analyse statistique
    Identifiant des informations: 113519
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulaire de consentement éclairé
    Identifiant des informations: 113519
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  4. Ensemble de données de participant individuel
    Identifiant des informations: 113519
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protocole d'étude
    Identifiant des informations: 113519
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formulaire de rapport de cas annoté
    Identifiant des informations: 113519
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  7. Spécification du jeu de données
    Identifiant des informations: 113519
    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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