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Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children

17 février 2020 mis à jour par: GlaxoSmithKline

Assess Reactogenicity & Safety of a Booster of Either Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix Given (Single-blind) at 15-18 (Philippines)/15-24 Mths (Thailand) & a Dose of Mencevax ACWY at 24-30 Mths (Open Label)

This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child. In the Mencevax ACWY phase at 24-30 months, a dose of Mencevax ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix-HepB/Hib-MenAC. No blood samples will be taken in this safety study.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Subjects previously primed with Tritanrix-HepB/Hib-MenAC will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m), respectively, without or with Mencevax ACWY vaccine at 24 to 30 months of age. Subjects previously primed with Tritanrix-HepB/Hiberix will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m) with Mencevax ACWY vaccine at 24 to 30 months of age.

Type d'étude

Interventionnel

Inscription (Réel)

798

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

  • Philippines
      • Muntinlupa, Philippines, 1781
        • GSK Investigational Site
  • Thaïlande
      • Bangkok, Thaïlande, 10400
        • 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 an à 1 an (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (Philippines)/ 15 and 24 months age (Thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
  • Chronic administration (> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral poliovirus vaccine can be given concomitantly.
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study.

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: ACAC_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study ( NCT00317187) are boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
Biologique: Tritanrix-HepB/Hib-MenAC
Vaccin conjugué diphtérie, tétanos, coqueluche à cellules entières, hépatite B, Haemophilus influenzae type b méningocoque AC-anatoxine tétanique
Expérimental: ACHibPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
Biologique: Tritanrix-HepB/Hiberix
Vaccin combiné diphtérie, tétanos, coqueluche, hépatite B, vaccin conjugué Haemophilus influenzae type b
Biologique: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Expérimental: HibACPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
Biologique: Tritanrix-HepB/Hib-MenAC
Vaccin conjugué diphtérie, tétanos, coqueluche à cellules entières, hépatite B, Haemophilus influenzae type b méningocoque AC-anatoxine tétanique
Biologique: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Expérimental: HibHibPS_Thailand Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
Biologique: Tritanrix-HepB/Hiberix
Vaccin combiné diphtérie, tétanos, coqueluche, hépatite B, vaccin conjugué Haemophilus influenzae type b
Biologique: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Expérimental: ACAC_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age
Biologique: Tritanrix-HepB/Hib-MenAC
Vaccin conjugué diphtérie, tétanos, coqueluche à cellules entières, hépatite B, Haemophilus influenzae type b méningocoque AC-anatoxine tétanique
Expérimental: ACHibPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
Biologique: Tritanrix-HepB/Hiberix
Vaccin combiné diphtérie, tétanos, coqueluche, hépatite B, vaccin conjugué Haemophilus influenzae type b
Biologique: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Expérimental: HibACPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
Biologique: Tritanrix-HepB/Hib-MenAC
Vaccin conjugué diphtérie, tétanos, coqueluche à cellules entières, hépatite B, Haemophilus influenzae type b méningocoque AC-anatoxine tétanique
Biologique: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Expérimental: HibHibPS_Philippines Group
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
Biologique: Tritanrix-HepB/Hiberix
Vaccin combiné diphtérie, tétanos, coqueluche, hépatite B, vaccin conjugué Haemophilus influenzae type b
Biologique: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Subjects With Fever >39°C (Rectal Route).
Délai: During the 4-day (Day 0-3) follow-up period after booster vaccination
Among solicited general symptoms fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )] was assessed, post vaccination. Grade 3 fever = fever > 39.0 °C.
During the 4-day (Day 0-3) follow-up period after booster vaccination

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C
Délai: During the 4-day (Day 0-3) follow-up period after vaccination
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
During the 4-day (Day 0-3) follow-up period after vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Délai: During the 4-day (Day 0-3) follow-up period after booster 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 30 millimeters (mm) of injection site.
During the 4-day (Day 0-3) follow-up period after booster vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Délai: During the 31-day (Day 0-30) following booster 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.
During the 31-day (Day 0-30) following booster vaccination
Number of Subjects With Serious Adverse Events (SAEs).
Délai: From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination
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.
From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post 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.

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 (Réel)

16 juin 2005

Achèvement primaire (Réel)

20 janvier 2006

Achèvement de l'étude (Réel)

20 janvier 2006

Dates d'inscription aux études

Première soumission

27 septembre 2005

Première soumission répondant aux critères de contrôle qualité

27 septembre 2005

Première publication (Estimation)

29 septembre 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 février 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 février 2020

Dernière vérification

1 février 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 103812
  • 104171 (Autre identifiant: GSK)

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. Plan d'analyse statistique
    Identifiant des informations: 103812
    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: 103812
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103812 are summarised with study 104727 on the GSK Clinical Study Register.
  3. Formulaire de consentement éclairé
    Identifiant des informations: 103812
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  4. Protocole d'étude
    Identifiant des informations: 103812
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  5. Spécification du jeu de données
    Identifiant des informations: 103812
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  6. Rapport d'étude clinique
    Identifiant des informations: 103812
    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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