Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

27 dicembre 2019 aggiornato da: GlaxoSmithKline

Efficacy, Safety, Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants

This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Combined diphtheria and tetanus toxoids and acellular pertussis (DTPa) and Hepatitis B (HBV) vaccines are allowed to be co-administered along with Rotarix vaccine/Placebo.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

765

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

  • Giappone
      • Aichi, Giappone, 451-0052
        • GSK Investigational Site
      • Chiba, Giappone, 275-8580
        • GSK Investigational Site
      • Fukuoka, Giappone, 802-8533
        • GSK Investigational Site
      • Hiroshima, Giappone, 720-8520
        • GSK Investigational Site
      • Hiroshima, Giappone, 734-8530
        • GSK Investigational Site
      • Hiroshima, Giappone, 737-0811
        • GSK Investigational Site
      • Hiroshima, Giappone, 730-8518
        • GSK Investigational Site
      • Hiroshima, Giappone, 730-8798
        • GSK Investigational Site
      • Hokkaido, Giappone, 065-0033
        • GSK Investigational Site
      • Hokkaido, Giappone, 003-0021
        • GSK Investigational Site
      • Kagawa, Giappone, 765-8501
        • GSK Investigational Site
      • Kanagawa, Giappone, 247-8533
        • GSK Investigational Site
      • Miyagi, Giappone, 983-8520
        • GSK Investigational Site
      • Miyagi, Giappone, 981-3203
        • GSK Investigational Site
      • Nagano, Giappone, 386-8610
        • GSK Investigational Site
      • Nagasaki, Giappone, 856-8562
        • GSK Investigational Site
      • Niigata, Giappone, 957-8588
        • GSK Investigational Site
      • Okayama, Giappone, 701-1192
        • GSK Investigational Site
      • Okayama, Giappone, 701-0204
        • GSK Investigational Site
      • Osaka, Giappone, 591-8025
        • 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 1 mese a 3 mesi (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Healthy male or female infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.
  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Born between a gestation period of 36 and 42 weeks inclusive.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
  • History of use of experimental rotavirus vaccine.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • 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 (pharmaceutical product or device).
  • Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception.
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Previous confirmed occurrence of RV GE.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
  • A family history of congenital or hereditary immunodeficiency.
  • Acute disease at the time of enrolment.
  • Gastroenteritis within 7 days preceding the study vaccine administration.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

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: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Rotarix Group
Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
Biologico: Rotarix
Two-dose oral vaccination.
Comparatore placebo: Placebo Group
Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Biologico: Placebo
Two-dose oral administration.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
Lasso di tempo: From 2 weeks after Dose 2 up to 2 years of age
Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
From 2 weeks after Dose 2 up to 2 years of age

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
Lasso di tempo: From 2 weeks after Dose 2 up to 2 years of age
A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).
From 2 weeks after Dose 2 up to 2 years of age
Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type
Lasso di tempo: From 2 weeks after Dose 2 up to 2 years of age

Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.

Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).
From 2 weeks after Dose 2 up to 2 years of age
Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types
Lasso di tempo: From 2 weeks after Dose 2 up to 2 years of age

Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.

Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).
From 2 weeks after Dose 2 up to 2 years of age
Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains
Lasso di tempo: From 2 weeks after Dose 2 up to 2 years of age
Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
From 2 weeks after Dose 2 up to 2 years of age
Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
Lasso di tempo: From Dose 1 up to 2 years of age

Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.

Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).
From Dose 1 up to 2 years of age
Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration
Lasso di tempo: 2 months after Dose 2
Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs). Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL).
2 months after Dose 2
Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies
Lasso di tempo: 2 months after Dose 2
Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e. prior to the first dose of rotarix) seronegative.
2 months after Dose 2
Number of Subjects Reporting Solicited Symptoms
Lasso di tempo: During the 8-day follow-up period after each dose
Solicited symptoms assessed include cough, diarrhoea, fever, irritability, loss of appetite and vomiting.
During the 8-day follow-up period after each dose
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Lasso di tempo: During the 31-day follow-up period after each dose
Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
During the 31-day follow-up period after each dose
Number of Subjects Reporting Serious Adverse Events (SAEs)
Lasso di tempo: Up to 2 years of age
Serious adverse events (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.
Up to 2 years of age

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)

19 giugno 2007

Completamento primario (Effettivo)

31 marzo 2009

Completamento dello studio (Effettivo)

21 novembre 2009

Date di iscrizione allo studio

Primo inviato

29 maggio 2007

Primo inviato che soddisfa i criteri di controllo qualità

29 maggio 2007

Primo Inserito (Stima)

30 maggio 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 gennaio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 dicembre 2019

Ultimo verificato

1 dicembre 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 107625
  • 2015-001543-36 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

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

SÌ

Descrizione del piano IPD

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Periodo di condivisione IPD

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Dati/documenti di studio

  1. Modulo di consenso informato
    Identificatore informazioni: 107625
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Piano di analisi statistica
    Identificatore informazioni: 107625
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Set di dati del singolo partecipante
    Identificatore informazioni: 107625
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Protocollo di studio
    Identificatore informazioni: 107625
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Specifica del set di dati
    Identificatore informazioni: 107625
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Modulo di segnalazione del caso annotato
    Identificatore informazioni: 107625
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Rapporto di studio clinico
    Identificatore informazioni: 107625
    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 .

Sottoscrivi