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Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects

8 maggio 2018 aggiornato da: GlaxoSmithKline

Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY

The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1025

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

  • Filippine
      • Muntinlupa, Filippine, 1781
        • GSK Investigational Site
  • India
      • Goa, India, 403202
        • GSK Investigational Site
      • Indore, India, 452001
        • GSK Investigational Site
      • New Delhi, India, 110002
        • GSK Investigational Site
      • Pune, India, 411 011
        • GSK Investigational Site
  • Taiwan
      • Taipei, Taiwan, 100
        • GSK Investigational Site
      • Tao Yuan County, Taiwan, 333
        • 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 11 anni a 17 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 11 and 17 years of age at the time of the vaccination.
  • Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge.
  • If the subject is female, she must be of non-childbearing potential, or 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 vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) 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 one month of the dose of vaccine.
  • Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
  • Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
  • Previous vaccination with tetanus toxoid within the last month.
  • History of meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
  • History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

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: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Group A
Subjects of 11-17 years of age who will receive GSK134612
Biologico: Vaccino meningococcico GSK134612
Una dose intramuscolare
Comparatore attivo: Group B
Subjects of 11-17 years of age who will receive MencevaxTM ACWY
Biologico: Mencevax™ ACWY
One subcutaneous dose

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects With Vaccine Response to Meningococcal Antigens
Lasso di tempo: One month post-vaccination (At Month 1)
Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8].
One month post-vaccination (At Month 1)
Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms
Lasso di tempo: During the 4-day (Days 0-3) period after vaccination
General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C).
During the 4-day (Days 0-3) period after vaccination

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values
Lasso di tempo: Prior to (Month 0) and one month after vaccination (Month 1)
Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Prior to (Month 0) and one month after vaccination (Month 1)
Meningococcal rSBA Antibody Titers
Lasso di tempo: Prior to (Month 0) and one month after vaccination (Month 1)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).
Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value
Lasso di tempo: Prior to (Month 0) and one month after vaccination (Month 1)
The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL).
Prior to (Month 0) and one month after vaccination (Month 1)
Anti-TT Antibody Concentrations
Lasso di tempo: Prior to (Month 0) and one month after vaccination (Month 1)
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values
Lasso di tempo: Prior to (Month 0) and one month after vaccination (Month 1)
The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Prior to (Month 0) and one month after vaccination (Month 1)
Anti-meningococcal Polysaccharide Concentrations
Lasso di tempo: Prior to (Month 0) and one month after vaccination (Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Lasso di tempo: During the 4-day (Days 0-3) period after vaccination
Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm).
During the 4-day (Days 0-3) period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Lasso di tempo: During the 4-day (Days 0-3) period after vaccination
Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination.
During the 4-day (Days 0-3) period after vaccination
Number of Subjects With Any Unsolicited Adverse Events
Lasso di tempo: During the 31-day (Days 0-30) post-vaccination period
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 (Days 0-30) post-vaccination period
Number of Subjects With Any Serious Adverse Events (SAEs)
Lasso di tempo: Up to study end (Month 6)
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.
Up to study end (Month 6)
Number of Subjects With Specific Adverse Events
Lasso di tempo: Up to study end (Month 6)
These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease).
Up to study end (Month 6)

Collaboratori e investigatori

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

Sponsor

GlaxoSmithKline

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.

Pubblicazioni generali

Collegamenti utili

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 (Effettivo)

2 maggio 2007

Completamento primario (Effettivo)

16 aprile 2008

Completamento dello studio (Effettivo)

10 settembre 2008

Date di iscrizione allo studio

Primo inviato

23 aprile 2007

Primo inviato che soddisfa i criteri di controllo qualità

23 aprile 2007

Primo Inserito (Stima)

24 aprile 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 maggio 2018

Ultimo verificato

1 marzo 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 109069

Piano per i dati dei singoli partecipanti (IPD)

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

SÌ

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: 109069
    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: 109069
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Specifica del set di dati
    Identificatore informazioni: 109069
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Protocollo di studio
    Identificatore informazioni: 109069
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Rapporto di studio clinico
    Identificatore informazioni: 109069
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Set di dati del singolo partecipante
    Identificatore informazioni: 109069
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Modulo di consenso informato
    Identificatore informazioni: 109069
    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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