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Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects

28 juin 2018 mis à jour par: GlaxoSmithKline

Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) 580299 Vaccine in Healthy Chinese Female Subjects

This study is designed to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in pre-teen and adolescent female subjects aged 9 - 17 years. One group of subjects will receive the HPV vaccine and the other group will receive the control.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

750

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

  • Chine
    • Jiangsu
      • Taizhou, Jiangsu, Chine, 225300
        • 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

9 ans à 17 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Subjects who the investigator believes that they or their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • Healthy Chinese females between and including 9 and 17 years of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
  • Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
  • Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test before each vaccination.
  • Subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and agree to continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration 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 30 days before and 30 days after (i.e., Days 0-29) the first dose of vaccine.
  • 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.
  • A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
  • Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
  • Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period.
  • Previous administration of components of the study vaccine.
  • History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
  • History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine.
  • Hypersensitivity to latex.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

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: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cervarix Group
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Biologique: CervarixTM
Subjects will receive three doses of the Cervarix vaccine intramuscularly according to a 0, 1, 6-month schedule.
Expérimental: Placebo Group
Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Autre: Control
Subjects will receive three doses of control intramuscularly according to a 0, 1, 6-month schedule.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens
Délai: One month after the third dose (at Month 7)
Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
One month after the third dose (at Month 7)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
Délai: At Month 7
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.
At Month 7
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Délai: During the 7 days (Days 0 - 6) following each vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).
During the 7 days (Days 0 - 6) following each vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Délai: During the 7 days (Days 0 - 6) following each vaccination
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
During the 7 days (Days 0 - 6) following each vaccination
Number of Subjects Reporting Medically Significant Conditions (MSCs)
Délai: Throughout the study period (from Day 0 up to Month 12)

Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.

MSCs were collected regardless of causal relationship to vaccination and intensity.
Throughout the study period (from Day 0 up to Month 12)
Number of Subjects Reporting Pregnancies and Pregnancy Outcomes
Délai: Throughout the study period (from Day 0 up to Month 12)
Throughout the study period (from Day 0 up to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Délai: Within 30 days (Days 0 - 29) after any vaccination
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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Within 30 days (Days 0 - 29) after any vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Délai: Throughout the study period (from Day 0 up to Month 12)
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 was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Throughout the study period (from Day 0 up to Month 12)

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

24 octobre 2009

Achèvement primaire (Réel)

8 décembre 2010

Achèvement de l'étude (Réel)

8 décembre 2010

Dates d'inscription aux études

Première soumission

15 octobre 2009

Première soumission répondant aux critères de contrôle qualité

15 octobre 2009

Première publication (Estimation)

16 octobre 2009

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

28 juin 2018

Dernière vérification

1 septembre 2016

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 112022

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. Ensemble de données de participant individuel
    Identifiant des informations: 112022
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formulaire de consentement éclairé
    Identifiant des informations: 112022
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  3. Spécification du jeu de données
    Identifiant des informations: 112022
    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: 112022
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protocole d'étude
    Identifiant des informations: 112022
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  6. Plan d'analyse statistique
    Identifiant des informations: 112022
    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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