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A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.

9 gennaio 2018 aggiornato da: GlaxoSmithKline

A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.

The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. 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

This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator.

One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study.

The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo.

The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

200

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

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:

  • Subjects with a live twin living in the same household who is also enrolled in this study.
  • Born after a gestation period of ≥32 weeks,
  • Discharged from hospital neonatal care stay,
  • 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.
  • A male or female between, and including, 6 and 14 weeks of age at the time of the first study vaccination.
  • 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 subjects.

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.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Any clinically significant history of chronic gastrointestinal disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Contact with an immunosuppressed individual.
  • 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).
  • Chronic administration of immunosuppressants since birth.
  • Gastroenteritis within 7 days preceding the first study vaccine administration.
  • Documented HIV-positive subject.

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: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Rotarix Group

All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).

Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).
Biologico: Rotarix
Two-dose oral vaccination.
Comparatore placebo: Placebo Group

All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).

Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).
Biologico: Rotarix
Two-dose oral vaccination.
Biologico: Placebo
Two-dose oral administration.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.
Lasso di tempo: On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.
Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.
On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Duration of Human Rotavirus (HRV) Shedding Per Study Group.
Lasso di tempo: From Day 0 up to Week 13.
Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen.
From Day 0 up to Week 13.
Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.
Lasso di tempo: During the entire study period (up to Visit 4, Week 17).
Dissimilar amino acid substitutions in the HRV vaccine strain isolated from the twin receiving placebo, when compared to the genetic variation of HRV vaccine strain isolated from the Rotarix vaccine recipients, were counted as genetic variation differences.
During the entire study period (up to Visit 4, Week 17).
Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.
Lasso di tempo: During the entire study period (up to Visit 4, Week 17).
Number of subjects in the Placebo Group with live virus identified in at least one stool sample in case of transmission.
During the entire study period (up to Visit 4, Week 17).
Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.
Lasso di tempo: At Visit 3 (Week 13).
Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose.
At Visit 3 (Week 13).
Anti-rotavirus IgA Antibody Concentration.
Lasso di tempo: At Visit 3 (Week 13).
Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals.
At Visit 3 (Week 13).
Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.
Lasso di tempo: Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.

GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting.

RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA).
Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Lasso di tempo: Within 31 days after any doses.
An AE is 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.
Within 31 days after any doses.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
Lasso di tempo: Up to Visit 4.

A serious adverse event (SAE) is any untoward medical occurrence that:

results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Up to Visit 4.

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)

23 gennaio 2007

Completamento primario (Effettivo)

23 gennaio 2008

Completamento dello studio (Effettivo)

13 febbraio 2008

Date di iscrizione allo studio

Primo inviato

6 novembre 2006

Primo inviato che soddisfa i criteri di controllo qualità

6 novembre 2006

Primo Inserito (Stima)

7 novembre 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 febbraio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 gennaio 2018

Ultimo verificato

1 novembre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 106260

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. Modulo di consenso informato
    Identificatore informazioni: 106260
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Specifica del set di dati
    Identificatore informazioni: 106260
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protocollo di studio
    Identificatore informazioni: 106260
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Set di dati del singolo partecipante
    Identificatore informazioni: 106260
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Piano di analisi statistica
    Identificatore informazioni: 106260
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Rapporto di studio clinico
    Identificatore informazioni: 106260
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Modulo di segnalazione del caso annotato
    Identificatore informazioni: 106260
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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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Prove cliniche su Rotarix

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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