- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00972517
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
11 juin 2019 mis à jour par: GlaxoSmithKline
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This Protocol Posting has been updated following Protocol amendment 1, October 2009.
The impacted section are the study design section, the outcomes measures section and the intervention section.
Type d'étude
Interventionnel
Inscription (Réel)
245
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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Baden-Wuerttemberg
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Kehl, Baden-Wuerttemberg, Allemagne, 77694
- GSK Investigational Site
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Schwaebisch-Hall, Baden-Wuerttemberg, Allemagne, 74523
- GSK Investigational Site
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Stuttgart, Baden-Wuerttemberg, Allemagne, 70469
- GSK Investigational Site
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Bayern
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Bindlach, Bayern, Allemagne, 95463
- GSK Investigational Site
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Muenchen, Bayern, Allemagne, 81241
- GSK Investigational Site
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Noerdlingen, Bayern, Allemagne, 86720
- GSK Investigational Site
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Rheinland-Pfalz
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Frankenthal, Rheinland-Pfalz, Allemagne, 67227
- GSK Investigational Site
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Worms, Rheinland-Pfalz, Allemagne, 67547
- 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
3 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 their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
- Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
- Healthy children as established by medical history and clinical examination when entering into the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Previous administration of any H1N1 A/California-like vaccine.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- If the subject is female and 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 completion of the vaccination series.
- Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
- Child in Care.
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: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Group A
Subjects receiving alternative dose of GSK23440272A vaccine
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Three intramuscular injections
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Délai: At Day 0, Day 21 and Day 42
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Antibody titers were expressed as Geometric mean titers (GMTs).
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At Day 0, Day 21 and Day 42
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Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Délai: At Day 42
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A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
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At Day 42
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Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Délai: At Day 42
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A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
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At Day 42
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HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
Délai: At Day 42
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GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
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At Day 42
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Délai: At Month 6
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Antibody titers were expressed as geometric mean titers (GMTs)
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At Month 6
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Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Délai: At Month 12
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Antibody titers were expressed as geometric mean titers (GMTs)
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At Month 12
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Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Délai: At Month 6
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A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
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At Month 6
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Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Délai: At Month 6
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A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
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At Month 6
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Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Délai: At Month 12
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A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
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At Month 12
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HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
Délai: At Month 6
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GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
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At Month 6
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Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
Délai: At Day 0, Day 21, Day 42 and Month 6
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Antibody titers were expressed as Geometric mean titers (GMTs).
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At Day 0, Day 21, Day 42 and Month 6
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Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
Délai: At Month 12
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Antibody titers were expressed as Geometric mean titers (GMTs).
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At Month 12
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Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
Délai: At Day 21 and Day 42
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A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
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At Day 21 and Day 42
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Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
Délai: At Month 6
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A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
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At Month 6
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Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Délai: During the 7-day (Days 0-6) post-vaccination period
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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 significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school or cried when limb was moved/spontaneously painful.
Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. > 50mm.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Délai: During the 7-day (Days 0-6) post-vaccination period
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Solicited general symptoms assessed were arthralgia, diarrhoea, drowsiness, fatigue, gastro-intestinal symptoms, headache, irritability, loss of appetite, myalgia, shivering, sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)].
Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination.
Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Grade 3 symptoms = symptoms that prevented normal activity.
Grade 3 fever = axillary temperature above 39.0°C.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)
Délai: During the entire study period (Day 0 to Month 12)
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MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination.
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During the entire study period (Day 0 to Month 12)
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Number of Subjects Reporting Any Adverse Events of Specific Interest (AESI)/Potential Immune-mediated Diseases (pIMDs)
Délai: During the entire study period (Day 0 to Month 12)
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Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune etiology.
"Any pIMD" was defined as at least one pIMD experienced by the study subject.
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During the entire study period (Day 0 to Month 12)
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Délai: Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination
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An unsolicited AE was defined as any AE (i.e.
any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
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Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Délai: During the entire study period (Day 0 to Month 12)
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A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was 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.
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During the entire study period (Day 0 to Month 12)
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Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Délai: At Day 0, Day 21, Day 42 and Month 6 (M6)
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Subjects were categorized by age and according to their results at pre-vaccination (Day 0), Day 21, Day 42 and Month 6 which were below, within and above the normal ranges or unknown as measured by validated assay according to international standards.
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At Day 0, Day 21, Day 42 and Month 6 (M6)
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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.
Publications générales
- Garcia-Sicilia J, Gillard P, Carmona A, Tejedor JC, Aristegui J, Merino JM, Behre U, Caplanusi A, Vaman T, Dieussaert I. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 2011 Jun 10;29(26):4353-61. doi: 10.1016/j.vaccine.2011.04.011. Epub 2011 Apr 17.
- Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359-69. doi: 10.1080/21645515.2015.1063754.
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)
29 septembre 2009
Achèvement primaire (Réel)
22 novembre 2010
Achèvement de l'étude (Réel)
22 novembre 2010
Dates d'inscription aux études
Première soumission
3 septembre 2009
Première soumission répondant aux critères de contrôle qualité
4 septembre 2009
Première publication (Estimation)
7 septembre 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 juin 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 113638
- 2009-015011-41 (Numéro EudraCT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Oui
Description du régime IPD
IPD for this study will be made available via the Clinical Study Data Request site.
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
- Plan d'analyse statistique (PAS)
- Formulaire de consentement éclairé (ICF)
- Rapport d'étude clinique (CSR)
Données/documents d'étude
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Formulaire de consentement éclairé
Identifiant des informations: 113638Commentaires 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: 113638Commentaires 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: 113638Commentaires 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: 113638Commentaires 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: 113638Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Plan d'analyse statistique
Identifiant des informations: 113638Commentaires 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: 113638Commentaires 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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Essais cliniques sur GSK investigational vaccine GSK2340272A
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GlaxoSmithKlineRésilié
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GlaxoSmithKlineComplété
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GlaxoSmithKlineComplété
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GlaxoSmithKlineComplété
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GlaxoSmithKlineComplété
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GlaxoSmithKlineComplété