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Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

31 luglio 2017 aggiornato da: GlaxoSmithKline

Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.

Panoramica dello studio

Stato

Completato

Condizioni

Tipo di studio

Interventistico

Iscrizione (Effettivo)

210

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Bilbao, Spagna, 48013
        • GSK Investigational Site
      • Burgos, Spagna, 09005
        • GSK Investigational Site
      • Madrid, Spagna, 28046
        • GSK Investigational Site
      • Móstoles/Madrid, Spagna, 28935
        • GSK Investigational Site
      • Sevilla, Spagna, 41013
        • GSK Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 3 anni a 17 anni (Bambino)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Gruppo A
Two primary intramuscular (IM) injections and a booster IM injection

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Lasso di tempo: At Day 0
The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
At Day 0
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Lasso di tempo: At Day 42
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
At Day 42
Titers for Serum HI Antibodies
Lasso di tempo: At Day 0
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
At Day 0
Titers for Serum HI Antibodies
Lasso di tempo: At Day 42
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
At Day 42
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Lasso di tempo: At Day 42
A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
At Day 42
Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
Lasso di tempo: At Day 42
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
At Day 42
Seroconversion Factor (SCF) for HI Antibody Titers
Lasso di tempo: At Day 42
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
At Day 42

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Numero di soggetti con qualsiasi sintomo locale sollecitato e di grado 3
Lasso di tempo: Durante il periodo post-vaccinale di 7 giorni (giorni 0-6) dopo ciascuna dose e tra le dosi
I sintomi locali sollecitati valutati erano dolore, arrossamento e gonfiore. Qualsiasi = occorrenza del sintomo indipendentemente dal grado di intensità. Dolore di grado 3 = dolore che ha impedito la normale attività. Rossore/gonfiore di grado 3 = rossore/gonfiore diffuso oltre 50 millimetri (mm) dal sito di iniezione.
Durante il periodo post-vaccinale di 7 giorni (giorni 0-6) dopo ciascuna dose e tra le dosi
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Lasso di tempo: At Days 0, 21, 42 and at Month 12
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
At Days 0, 21, 42 and at Month 12
Titers for Serum HI Antibodies
Lasso di tempo: At Days 0, 21, 42 and at Month 12
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
At Days 0, 21, 42 and at Month 12
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Lasso di tempo: At Days 21, 42 and at Month 12
A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09.
At Days 21, 42 and at Month 12
Number of Seroprotected Subjects in Terms of HI Antibodies
Lasso di tempo: At Days 0, 21, 42 and at Month 12
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
At Days 0, 21, 42 and at Month 12
Seroconversion Factor (SCF) for HI Antibody Titers
Lasso di tempo: At Days 21, 42 and at Month 12
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
At Days 21, 42 and at Month 12
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Lasso di tempo: At Days 0, 21 and 42
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
At Days 0, 21 and 42
Titers for Serum Neutralizing Antibodies
Lasso di tempo: At Days 0, 21 and 42
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).
At Days 0, 21 and 42
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Lasso di tempo: At Month 12
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
At Month 12
Titers for Serum Neutralizing Antibodies
Lasso di tempo: At Month 12
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was Flu A/Neth/602/09.
At Month 12
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Lasso di tempo: At Days 21 and 42
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
At Days 21 and 42
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Lasso di tempo: At Month 12
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
At Month 12
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Lasso di tempo: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Lasso di tempo: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any Medically-attended Events (MAEs)
Lasso di tempo: During the entire study period (from Day 0 up to Month 12)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)
Lasso di tempo: During the entire study period (from Day 0 up to Month 12)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects With Normal or Abnormal Biochemical Levels
Lasso di tempo: At Days 0, 21 and 42
Among biochemical parameters assessed were alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], bilirubin [BILI], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
At Days 0, 21 and 42
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Lasso di tempo: During the 21-day (Days 0-20) follow-up period after the first 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
During the 21-day (Days 0-20) follow-up period after the first vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Lasso di tempo: During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Lasso di tempo: During the entire study period (from Day 0 up to Month 12)
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.
During the entire study period (from Day 0 up to Month 12)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

10 settembre 2009

Completamento primario (Effettivo)

27 novembre 2010

Completamento dello studio (Effettivo)

27 novembre 2010

Date di iscrizione allo studio

Primo inviato

20 agosto 2009

Primo inviato che soddisfa i criteri di controllo qualità

20 agosto 2009

Primo Inserito (Stima)

24 agosto 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 febbraio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 luglio 2017

Ultimo verificato

1 ottobre 2016

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Dati/documenti di studio

  1. Piano di analisi statistica
    Identificatore informazioni: 113528
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Modulo di segnalazione del caso annotato
    Identificatore informazioni: 113528
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Modulo di consenso informato
    Identificatore informazioni: 113528
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Rapporto di studio clinico
    Identificatore informazioni: 113528
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Set di dati del singolo partecipante
    Identificatore informazioni: 113528
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Protocollo di studio
    Identificatore informazioni: 113528
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Specifica del set di dati
    Identificatore informazioni: 113528
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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