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Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.

2. juli 2018 opdateret af: GlaxoSmithKline

Immunogenicity, Reactogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.

The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after birth.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Taiwan
      • Taipei, Taiwan, 100
        • GSK Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 måned til 2 måneder (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
  • A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/Legally Acceptable Representative(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Infants who have received a previous dose of hepatitis B immunoglobulin after birth.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs with the exception of Hepatitis B immunoglobulin since birth. Child is unlikely to remain in the study area for the duration of the study.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
  • 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.
  • Previous vaccination against rotavirus.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins (with the exception of HBIG) and/or any blood products since birth or planned administration during the study period.
  • Gastroenteritis within 7 days preceding the study vaccine administration.
  • Previous confirmed occurrence of Rotavirus gastroenteritis.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Rotarix Group
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
Biologisk: Rotarix TM
Oral, 2 doses

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.
Tidsramme: 2 months post-Dose 2 (at study Month 4)
Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (<) 20 U/mL.
2 months post-Dose 2 (at study Month 4)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum Anti-rotavirus IgA Antibody Concentrations.
Tidsramme: 2 months post-Dose 2 (at study Month 4)
Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects.
2 months post-Dose 2 (at study Month 4)
Number of Subjects Reporting Solicited General Symptoms.
Tidsramme: During the 8-day (Days 0-7) post-vaccination period
Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting.
During the 8-day (Days 0-7) post-vaccination period
Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.
Tidsramme: From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)

RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample.

GE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA).
From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Tidsramme: Within the 31-day (Days 0-30) follow-up period after vaccination
An unsolicited adverse event is any adverse event (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.
Within the 31-day (Days 0-30) follow-up period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs).
Tidsramme: During the entire study period (from Dose 1 at Day 0 up to Month 4)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
During the entire study period (from Dose 1 at Day 0 up to Month 4)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

11. november 2010

Primær færdiggørelse (Faktiske)

18. april 2011

Studieafslutning (Faktiske)

18. april 2011

Datoer for studieregistrering

Først indsendt

9. september 2010

Først indsendt, der opfyldte QC-kriterier

9. september 2010

Først opslået (Skøn)

10. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2018

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 114351

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Studiedata/dokumenter

  1. Annoteret sagsbetænkningsformular
    Informations-id: 114351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Studieprotokol
    Informations-id: 114351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formular til informeret samtykke
    Informations-id: 114351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individuelt deltagerdatasæt
    Informations-id: 114351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Datasætspecifikation
    Informations-id: 114351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistisk analyseplan
    Informations-id: 114351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinisk undersøgelsesrapport
    Informations-id: 114351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Infektioner, Rotavirus

Kliniske forsøg med Rotarix TM

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