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Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control

2 juillet 2018 mis à jour par: GlaxoSmithKline

Clinical Study in Children, 6 Months to 3 Years of Age, to Assess the Immunogenicity and Safety of Two Dose Levels of Thimerosal-free Fluviral® Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control

Children younger than 5 years of age are at high risk for severe influenza disease (flu) and hospitalization due to flu. Scientists are in the process of re-evaluating the dosing initially based on whole virus vaccines to improve their efficacy in infants. In this study, we will compare two different dose levels of GSK1557482A flu vaccine. Another already approved flu vaccine made by a different company will be used as a control.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This is a study of two different dose levels of a new formulation of flu vaccine for the 2008/2009 flu season using the World Health Organization recommended virus strains. Subjects will be randomly put into one of three different groups to receive either one or two doses of:

0.25 mL dose of the new flu vaccine, or 0.5 mL dose of the new flu vaccine or the licensed Vaxigrip flu vaccine (control) The parents of the subjects and the study doctor and nurses will not know the group of their child until the study is completed.

The children will be vaccinated with either one dose or two doses depending on whether or not they have received a flu vaccine before. The doctor will decide on the schedule for each child based on the information provided by the parents. The active phase of the study will last approximately two months for children receiving two doses and one month for those receiving a single dose. An extended safety follow-up will continue until Study Month 6.

Two blood samples will be taken from each subject. These will be used to evaluate how well the vaccine works in the children and which dose level works best compared to the control.

The parents will fill in a diary card for four days to record any reactions or symptoms which may occur after vaccination. Parents will also keep a record of other symptoms that may occur between vaccinations and up to six months after the first vaccination and will keep a record of any medication their child takes in this time period.

Type d'étude

Interventionnel

Inscription (Réel)

390

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • GSK Investigational Site
    • British Columbia
      • Langley, British Columbia, Canada, V3A 4H9
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 5B6
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • GSK Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 5G8
        • GSK Investigational Site
      • London, Ontario, Canada, N6H 4P2
        • GSK Investigational Site
      • London, Ontario, Canada, N6A 5R9
        • GSK Investigational Site
      • Mississauga, Ontario, Canada, L5A 3V4
        • GSK Investigational Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • GSK Investigational Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3E 1H5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 1N8
        • GSK Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 5N4
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • GSK Investigational Site
      • Quebec City, Quebec, Canada, G1V 4M6
        • GSK Investigational Site
      • Ste-Foy, Quebec, Canada, G1X 3V7
        • GSK Investigational Site
      • Trois Rivières, Quebec, Canada, G8T 7A1
        • 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

6 mois à 3 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • A male or female child 6 months to < 3 years of age at the time of the vaccination, regardless of previous administration of influenza vaccine in a previous season;
  • Subjects must be in good health established by medical history and physical examination before entering into the study;
  • Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study;
  • Written informed consent obtained from the subject's parent/guardian.
  • Parents/guardian access to a consistent means of telephone contact, land line or mobile

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion;
  • History of hypersensitivity to any vaccine;
  • History of allergy to or reactions likely to be exacerbated by, any component of the vaccine including egg, chicken protein, formaldehyde, or sodium deoxycholate;
  • History of any congenital, acquired, or iatrogenic immunodeficiency state (current or potential) including HIV infection, disorders of the lymphoid system or bone marrow, or chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune-modifying drugs within 3 months prior to the administration of the study vaccine.
  • Acute disease at the time of enrolment.
  • History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine;
  • Any significant disorder of blood coagulation or treatment with vitamin K antagonists; or any known disorder of hemostasis;
  • Receipt of any immunoglobulins and/or any blood products within three months of study enrollment or planned administration of any of these products during the study period.
  • Receipt of a non-study related influenza vaccine outside of this study and during the current (2008-09) influenza immunization campaign.
  • Any use of analgesics/antipyretics 12 hours before receipt of 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: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Fluviral F1 Group
Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Biologique: GSK Biologicals' influenza vaccine GSK1557482A
one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
Autres noms:
  • Fluviral
Expérimental: Fluviral F2 Group
Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Biologique: GSK Biologicals' influenza vaccine GSK1557482A
one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
Autres noms:
  • Fluviral
Comparateur actif: Vaxigrip Group
Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Biologique: Vaxigrip
one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Délai: During the 4-day follow-up period (Days 0-3) after any vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 4-day follow-up period (Days 0-3) after any vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
Délai: During the 4-day follow-up period (Days 0-3) after any vaccination
Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 4-day follow-up period (Days 0-3) after any vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
Délai: During the 28-day follow-up period (Days 0-27) after vaccination
Unsolicited AEs 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 28-day follow-up period (Days 0-27) after vaccination
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Délai: During the 28-day post-vaccination period

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 28-day post-vaccination period
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Délai: During the 6-month safety follow up after vaccination

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 6-month safety follow up after vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Délai: During the 28-day post-vaccination period

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. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 28-day post-vaccination period
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Délai: During the 6-month safety follow up after vaccination

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. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
During the 6-month safety follow up after vaccination

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Titers for Serum Hemagglutination Inhibition (HI) Antibodies
Délai: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Number of Subjects Seroconverted to HI Antibodies
Délai: At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
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 flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Number of Subjects Seroprotected Against HI Antibodies
Délai: At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]

A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.

The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Seroconversion Factor for HI Antibodies
Délai: At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]

The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).

The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Délai: During the 4-day follow-up period (Days 0-3) after any vaccination

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 4-day follow-up period (Days 0-3) after any vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
Délai: During the 4-day follow-up period (Days 0-3) after any vaccination

Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 4-day follow-up period (Days 0-3) after any vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
Délai: During the 28-day follow-up period (Days 0-27) after vaccination

Unsolicited AEs 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 28-day follow-up period (Days 0-27) after vaccination
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Délai: During the 28-day post-vaccination period after vaccination

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 28-day post-vaccination period after vaccination
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Délai: During the 6-month safety follow up after vaccination

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 6-month safety follow up after vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Délai: During the 28-day post-vaccination period

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. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 28-day post-vaccination period
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Délai: During the 6-month safety follow up after vaccination

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. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
During the 6-month safety follow up after vaccination

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

10 novembre 2008

Achèvement primaire (Réel)

19 août 2009

Achèvement de l'étude (Réel)

19 août 2009

Dates d'inscription aux études

Première soumission

23 octobre 2008

Première soumission répondant aux critères de contrôle qualité

23 octobre 2008

Première publication (Estimation)

24 octobre 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 août 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juillet 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

  • 111635

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. Rapport d'étude clinique
    Identifiant des informations: 111635
    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: 111635
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  3. Plan d'analyse statistique
    Identifiant des informations: 111635
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  4. Formulaire de consentement éclairé
    Identifiant des informations: 111635
    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: 111635
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  6. Protocole d'étude
    Identifiant des informations: 111635
    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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