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Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age

31 décembre 2019 mis à jour par: GlaxoSmithKline

Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Réel)

360

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

      • Kolkata, Inde, 700073
        • GSK Investigational Site
      • Ludhiana, Inde, 141 008
        • GSK Investigational Site
      • Pune, Inde
        • GSK Investigational Site
      • Vellore, Inde, 632004
        • 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

1 mois à 2 mois (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
  • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
  • Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
  • Free of any known or suspected health problems (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) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • A family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
  • Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
  • History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of any neurological disorders or seizures.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Babies for which birth weight is < 2 kilogram.

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: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Synflorix & Tritanrix-HebB/Hib Group
Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Injection intramusculaire, 3 doses
Intramuscular injection, 3 doses
Autres noms:
  • DTPw-HBV/Hib
Comparateur actif: Hiberix group & Tritanrix-HebB Group
Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Intramuscular injection, 3 doses
Autres noms:
  • Hib
Intramuscular injection, 3 doses
Autres noms:
  • DTPw-HBV

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
Délai: One month after primary immunization (month 3)

Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL).

Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

One month after primary immunization (month 3)
Concentration of Antibody Against Protein D (PD)
Délai: One month after primary immunization (month 3)
Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
One month after primary immunization (month 3)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes
Délai: One month after primary immunization (month 3)

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Cross-reactive pneumococcal serotypes included 6A and 19A.

Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.

One month after primary immunization (month 3)
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value
Délai: One month after primary immunization

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.

The cut-off was defined as 0.20 microgram per milliliter (µg/mL).

One month after primary immunization
Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes
Délai: One month after primary immunization (month 3)
Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.
One month after primary immunization (month 3)
Number of Subjects Seropositive for Pneumococcal Serotypes
Délai: One month after primary immunization (month 3)

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.

Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL

One month after primary immunization (month 3)
Number of Subjects Seropositive for Protein D (PD)
Délai: One month after primary immunization (month 3)
Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.
One month after primary immunization (month 3)
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
Délai: One month after primary immunization (month 3)
Concentration is expressed as GMC in µg/mL.
One month after primary immunization (month 3)
Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)
Délai: One month after primary immunization (month 3)
Concentrations were expressed as GMCs in international units per milliliter (IU/mL).
One month after primary immunization (month 3)
Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)
Délai: One month after primary immunization (month 3)
Concentration was expressed as GMC in EL.U/mL.
One month after primary immunization (month 3)
Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Délai: One month after primary immunization (month 3)
Concentration was expressed as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.
One month after primary immunization (month 3)
Number of Subjects Seropostive for B. Pertussis
Délai: One month after primary immunization (month 3)
Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.
One month after primary immunization (month 3)
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)
Délai: One month after primary immunization (month 3)

Seroprotection was defined as:

Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL.

One month after primary immunization (month 3)
Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)
Délai: One month after primary immunization (month 3)
Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.
One month after primary immunization (month 3)
Number of Subjects With Solicited Local and General Symptoms
Délai: Within 4 days (day 0-3) after vaccination
Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.
Within 4 days (day 0-3) after vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Délai: Within 31 days (day 0-30) after vaccination

An AE is 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.

Unsolicited AE 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

Within 31 days (day 0-30) after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Délai: Following first vaccination (Month 0) throughout the entire study period (month 3)
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.
Following first vaccination (Month 0) throughout the entire study period (month 3)

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)

7 mars 2009

Achèvement primaire (Réel)

13 novembre 2009

Achèvement de l'étude (Réel)

13 novembre 2009

Dates d'inscription aux études

Première soumission

23 décembre 2008

Première soumission répondant aux critères de contrôle qualité

23 décembre 2008

Première publication (Estimation)

25 décembre 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 janvier 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 décembre 2019

Dernière vérification

1 décembre 2019

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Délai de partage IPD

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Critères d'accès au partage IPD

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Données/documents d'étude

  1. Protocole d'étude
    Identifiant des informations: 111188
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  2. Ensemble de données de participant individuel
    Identifiant des informations: 111188
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulaire de rapport de cas annoté
    Identifiant des informations: 111188
    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: 111188
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formulaire de consentement éclairé
    Identifiant des informations: 111188
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  6. Spécification du jeu de données
    Identifiant des informations: 111188
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  7. Plan d'analyse statistique
    Identifiant des informations: 111188
    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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