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Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants

7. december 2017 opdateret af: GlaxoSmithKline

Post Marketing Surveillance to Monitor the Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered According to the Prescribing Information to Indian Infants

This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

332

Kontakter og lokationer

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

Studiesteder

  • Indien
      • Bangalore, Indien, 560 011
        • GSK Investigational Site
      • Bangalore, Indien, 560 095
        • GSK Investigational Site
      • Chennai, Indien, 600 033
        • GSK Investigational Site
      • Delhi, Indien, 110085
        • GSK Investigational Site
      • Delhi, Indien, 110088
        • GSK Investigational Site
      • Kolkata, Indien, 700064
        • GSK Investigational Site
      • Kolkata, Indien
        • GSK Investigational Site
      • Mumbai, Indien, 400 053
        • GSK Investigational Site
      • Mumbai, Indien, 400081
        • GSK Investigational Site
      • Mumbai, Indien
        • GSK Investigational Site
      • New Delhi, Indien, 110087
        • GSK Investigational Site
      • Pune, Indien, 411044
        • 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 5 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

subjects from the age of 6 weeks at the time of the first Rotarix™ vaccination and less than 24 weeks of age at the time of second Rotarix™ vaccination

Beskrivelse

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in this PMS.
  • A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Acute disease at the time of enrolment.
  • Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the subject for intussusception.
  • Known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine.
  • Gastroenteritis within 7 days preceding vaccination.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Rotarix Group
Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
Biologisk: Rotarix™
Two doses of oral vaccine.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea)
Tidsramme: During the 8-day (Day 0 - Day 7) follow-up period after each vaccination.

Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C.

Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day.
During the 8-day (Day 0 - Day 7) follow-up period after each vaccination.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Subjects Reporting Solicited General Symptoms
Tidsramme: During the 8-day (Day 0 - Day 7) follow-up period after each vaccination
Cough: Cough/runny nose of any intensity Diarrhoea: Passage of three or more looser than normal stools within a day Irritability: Cried more than usual Loss of appetite: Ate less than usual Temperature: Axillary temperature greater than or equal to 37.5°C Vomiting: One or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day
During the 8-day (Day 0 - Day 7) follow-up period after each vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Tidsramme: During the 31-day (Day 0 - Day 30) follow-up period after each vaccination
Unsolicited AE covers any AE 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.
During the 31-day (Day 0 - Day 30) follow-up period after each vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Tidsramme: Throughout the study period (from Day 0 up to Day 30)
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.
Throughout the study period (from Day 0 up to Day 30)

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

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

3. august 2009

Primær færdiggørelse (Faktiske)

20. februar 2010

Studieafslutning (Faktiske)

23. april 2010

Datoer for studieregistrering

Først indsendt

9. juli 2009

Først indsendt, der opfyldte QC-kriterier

9. juli 2009

Først opslået (Skøn)

13. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. december 2017

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 112896

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™

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in France

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner