To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
23. februar 2021 opdateret af: GlaxoSmithKline
Open, Multicentric, Post-marketing Surveillance Study to Evaluate Safety and Reactogenicity of GSK Bio's Live Attenuated Oral Human Rotavirus (HRV) Vaccine, Rotarix When Administered According to Prescribing Information, in Filipino Subjects Aged at Least 6 Weeks of Age at the Time of First Vaccination
GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries.
In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The protocol was amended to reflect a change in the prescribing information.
The age of the infants was changed from 6 - 14 weeks to at least 6 weeks at the time of the first vaccination.
This protocol posting has been amended in order to comply with FDA AA.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1439
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Alabang, Muntinlupa City, Filippinerne, 1780
- GSK Investigational Site
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Binangonan, Rizal, Filippinerne
- GSK Investigational Site
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Cainta, Rizal, Filippinerne
- GSK Investigational Site
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Gen. Trias, Cavite, Filippinerne
- GSK Investigational Site
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Imus, Cavite, Filippinerne
- GSK Investigational Site
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Los Banos, Laguna, Filippinerne, 4027
- GSK Investigational Site
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Makati City, Filippinerne
- GSK Investigational Site
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Manila, Filippinerne, 1000
- GSK Investigational Site
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Manila, Filippinerne
- GSK Investigational Site
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Maybunga, Pasig City, Filippinerne
- GSK Investigational Site
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Muntinlupa City, Filippinerne, 1780
- GSK Investigational Site
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Pasay City, Filippinerne
- GSK Investigational Site
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Pasig City, Metro Manila, Filippinerne, 1600
- GSK Investigational Site
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Quezon City, Filippinerne, 1113
- GSK Investigational Site
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Quezon City, Filippinerne
- GSK Investigational Site
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Quezon City, Filippinerne, 1102
- GSK Investigational Site
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Talaba IV, Bacoor, Cavite, Filippinerne
- GSK Investigational Site
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Taytay, Rizal, Filippinerne
- GSK Investigational Site
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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
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Filipino subjects aged at least 6 weeks at the time of first vaccination
Beskrivelse
Inclusion Criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A Filipino male or female aged at least 6 weeks at the time of the first 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.
- Any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract.
- Any contraindications as stated in the Prescribing Information.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Cohort Group
Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
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Two doses of the oral vaccine
Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea).
Tidsramme: During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2).
|
Grade 2 or 3 symptoms assessed include fever, vomiting and diarrhea.
Grade 2 fever was defined as axillary temperature above 38.0
degrees Celsius (°C) and below or equal to 39.0°C or rectal temperature above 38.5°C
and below or equal to 39.5°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 diarrhea was defined as 4-5 looser than normal stools per day.
Grade 3 diarrhea was defined as at least 6 looser than normal stools per day.
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During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2).
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Tidsramme: During the 15-day solicited follow-up period (Day 0 to Day 14) after each vaccine dose (Dose 1 and Dose 2).
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Solicited symptoms assessed included cough, diarrhea, fever, irritability, loss of appetite and vomiting.
Any = Any reports of the specified symptom irrespective of intensity grade and relationship to vaccination.
Grade 3 symptom: symptom that prevented normal activity.
Grade 3 loss of appetite = not eating at all, grade 3 fever = axillary temperature > 39.0°C, grade 3 vomiting = ≥ 3 episodes of vomiting/day and grade 3 diarrhea = ≥ 6 looser than normal stools/day.
Related = symptom assessed by the investigator as causally related to the vaccination regardless of intensity grade.
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During the 15-day solicited follow-up period (Day 0 to Day 14) after each vaccine dose (Dose 1 and Dose 2).
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Tidsramme: During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose.
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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.
Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study.
Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
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During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose.
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Number of Subjects Reporting Serious Adverse Events (SAE)
Tidsramme: Throughout the study period (Day 0 to one month post-Dose 2).
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Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
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Throughout the study period (Day 0 to one month post-Dose 2).
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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 (Faktiske)
16. november 2006
Primær færdiggørelse (Faktiske)
31. marts 2010
Studieafslutning (Faktiske)
17. juli 2010
Datoer for studieregistrering
Først indsendt
17. juli 2006
Først indsendt, der opfyldte QC-kriterier
17. juli 2006
Først opslået (Skøn)
18. juli 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. februar 2021
Sidst verificeret
1. februar 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 103366
- 2012-004039-21 (EudraCT nummer)
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