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Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612

1 mars 2017 mis à jour par: GlaxoSmithKline

Persistence of Antibodies After Vaccination With GSK Biologicals' Meningococcal Vaccine GSK134612 in Adolescents and Young Adults

Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new studies will be enrolled. The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.

Type d'étude

Interventionnel

Inscription (Réel)

697

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

  • Inde
      • Goa, Inde, 403202
        • GSK Investigational Site
      • Indore, Inde, 452001
        • GSK Investigational Site
      • New Delhi, Inde, 110002
        • GSK Investigational Site
      • Pune, Inde, 411 011
        • GSK Investigational Site
  • Philippines
      • Muntinlupa, Philippines, 1781
        • 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

11 ans à 17 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
  • Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit.
  • History of meningococcal disease; such cases will be documented.
  • Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit.
  • Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
  • Subjects who withdrew consent to be contacted for follow-up studies.

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: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Group A
Subjects who received GSK Biologicals' meningococcal vaccine 134612 in the primary vaccination study 109069.
Procédure: Blood Sampling
A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study
Comparateur actif: Group B
Subjects who received MencevaxTM ACWY in the primary vaccination study 109069.
Procédure: Blood Sampling
A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Délai: At Month 24 post primary dose
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals' laboratory.
At Month 24 post primary dose
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Délai: At Month 36 post primary dose
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
At Month 36 post primary dose
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Délai: At Month 48 post primary dose
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
At Month 48 post primary dose
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Délai: At Month 60 post primary dose
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
At Month 60 post primary dose

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
Délai: At Months 24, 36, 48 and 60 post primary dose
A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
At Months 24, 36, 48 and 60 post primary dose
Antibody Titers Against the Vaccine Meningococcal Serogroups
Délai: At Months 24, 36, 48 and 60 post primary dose
Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
At Months 24, 36, 48 and 60 post primary dose
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Délai: At Month 24 post primary dose
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
At Month 24 post primary dose
Antibody Concentrations Against the Vaccine Polysaccharides
Délai: At Month 24 post primary dose
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
At Month 24 post primary dose

Collaborateurs et enquêteurs

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

Parrainer

GlaxoSmithKline

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 septembre 2009

Achèvement primaire (Réel)

1 mai 2013

Achèvement de l'étude (Réel)

1 mai 2013

Dates d'inscription aux études

Première soumission

7 septembre 2009

Première soumission répondant aux critères de contrôle qualité

9 septembre 2009

Première publication (Estimation)

10 septembre 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 avril 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 mars 2017

Dernière vérification

1 décembre 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 112148

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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