- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00464815
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
8 mai 2018 mis à jour par: GlaxoSmithKline
Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY
The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Type d'étude
Interventionnel
Inscription (Réel)
1025
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
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Goa, Inde, 403202
- GSK Investigational Site
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Indore, Inde, 452001
- GSK Investigational Site
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New Delhi, Inde, 110002
- GSK Investigational Site
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Pune, Inde, 411 011
- GSK Investigational Site
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Muntinlupa, Philippines, 1781
- GSK Investigational Site
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Taipei, Taïwan, 100
- GSK Investigational Site
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Tao Yuan County, Taïwan, 333
- GSK Investigational Site
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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
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 11 and 17 years of age at the time of the vaccination.
- Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge.
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after vaccination.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
- Previous vaccination with tetanus toxoid within the last month.
- History of meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- History of chronic alcohol consumption and/or drug abuse.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
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 |
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Expérimental: Group A
Subjects of 11-17 years of age who will receive GSK134612
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Une dose intramusculaire
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Comparateur actif: Group B
Subjects of 11-17 years of age who will receive MencevaxTM ACWY
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One subcutaneous dose
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Number of Subjects With Vaccine Response to Meningococcal Antigens
Délai: One month post-vaccination (At Month 1)
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Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8].
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One month post-vaccination (At Month 1)
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Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms
Délai: During the 4-day (Days 0-3) period after vaccination
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General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache.
Grade 3 symptom= event that prevented normal activities.
Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C).
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During the 4-day (Days 0-3) period after vaccination
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values
Délai: Prior to (Month 0) and one month after vaccination (Month 1)
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Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY).
The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
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Prior to (Month 0) and one month after vaccination (Month 1)
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Meningococcal rSBA Antibody Titers
Délai: Prior to (Month 0) and one month after vaccination (Month 1)
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rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).
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Prior to (Month 0) and one month after vaccination (Month 1)
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Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value
Délai: Prior to (Month 0) and one month after vaccination (Month 1)
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The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL).
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Prior to (Month 0) and one month after vaccination (Month 1)
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Anti-TT Antibody Concentrations
Délai: Prior to (Month 0) and one month after vaccination (Month 1)
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Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
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Prior to (Month 0) and one month after vaccination (Month 1)
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Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values
Délai: Prior to (Month 0) and one month after vaccination (Month 1)
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The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
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Prior to (Month 0) and one month after vaccination (Month 1)
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Anti-meningococcal Polysaccharide Concentrations
Délai: Prior to (Month 0) and one month after vaccination (Month 1)
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Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
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Prior to (Month 0) and one month after vaccination (Month 1)
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Délai: During the 4-day (Days 0-3) period after vaccination
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Solicited local symptoms assessed included pain, redness and swelling.
Any= incidence of a particular symptom regardless of intensity.
Grade 3 symptoms= symptoms that prevented normal activity.
Grade 3 swelling= swelling spreading beyond 50 millimeters (mm).
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During the 4-day (Days 0-3) period after vaccination
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Délai: During the 4-day (Days 0-3) period after vaccination
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Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)].
Any= incidence of a particular symptom regardless of intensity or relationship to vaccination.
Grade 3= event that prevented normal activities.
Grade 3 fever= fever > 39.5 °C.
Related= general symptom assessed by the investigator as causally related to the study vaccination.
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During the 4-day (Days 0-3) period after vaccination
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Number of Subjects With Any Unsolicited Adverse Events
Délai: During the 31-day (Days 0-30) post-vaccination period
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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.
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During the 31-day (Days 0-30) post-vaccination period
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Number of Subjects With Any Serious Adverse Events (SAEs)
Délai: Up to study end (Month 6)
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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.
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Up to study end (Month 6)
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Number of Subjects With Specific Adverse Events
Délai: Up to study end (Month 6)
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These events consist of specific categories of adverse events (AEs) which included rash (e.g.
hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g.
autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e.
meningococcal disease).
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Up to study end (Month 6)
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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 (Réel)
2 mai 2007
Achèvement primaire (Réel)
16 avril 2008
Achèvement de l'étude (Réel)
10 septembre 2008
Dates d'inscription aux études
Première soumission
23 avril 2007
Première soumission répondant aux critères de contrôle qualité
23 avril 2007
Première publication (Estimation)
24 avril 2007
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
8 mai 2018
Dernière vérification
1 mars 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 109069
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
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Plan d'analyse statistique
Identifiant des informations: 109069Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Formulaire de rapport de cas annoté
Identifiant des informations: 109069Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Spécification du jeu de données
Identifiant des informations: 109069Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Protocole d'étude
Identifiant des informations: 109069Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Rapport d'étude clinique
Identifiant des informations: 109069Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Ensemble de données de participant individuel
Identifiant des informations: 109069Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Formulaire de consentement éclairé
Identifiant des informations: 109069Commentaires 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 .
Essais cliniques sur Infections méningococciques
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Radboud University Medical CenterSint MaartenskliniekActif, ne recrute pasInfection du site opératoire | Infection articulaire | Infection, site chirurgical | Prothèse Infection Hanche et Genou | Infection liée aux prothèses | InfectionProPays-Bas
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West Virginia UniversityInscription sur invitationInfection de la peau et des tissus mous | Infection gastro-intestinale | Infection pulmonaire | Infection des os et des articulations | Infection endovasculaire | Infection génito-urinaireÉtats-Unis
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Croydon Health Services NHS TrustComplétéInfection du site opératoire | Infection de la plaie | Césarienne; Infection | Infection périnéaleRoyaume-Uni
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Taipei Medical University WanFang HospitalInconnue
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Ondine Biomedical Inc.ComplétéInfection du site opératoire | Infection nosocomiale | Infection associée aux soins de santéÉtats-Unis
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Angela BiancoStryker NordicRésiliéCésarienne | Infection du site opératoire | Infection nosocomialeÉtats-Unis
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Leiden University Medical CenterRadboud University Medical Center; University Medical Center Groningen; Erasmus... et autres collaborateursRecrutementInfection prothétique-articulaire | Infection de la hanche | Infection; Genou, ArticulationPays-Bas
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Cairo UniversityRecrutementInfection postopératoire | Complications de la césarienne | Infection vaginaleEgypte
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Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemComplétéInfection du site opératoire | Infection superficielle du site opératoire | Infection profonde du site chirurgical | Infection du site chirurgical d'un organe/de l'espaceÉtats-Unis
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