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 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
1439
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Alabang, Muntinlupa City, Philippinen, 1780
- GSK Investigational Site
-
Binangonan, Rizal, Philippinen
- GSK Investigational Site
-
Cainta, Rizal, Philippinen
- GSK Investigational Site
-
Gen. Trias, Cavite, Philippinen
- GSK Investigational Site
-
Imus, Cavite, Philippinen
- GSK Investigational Site
-
Los Banos, Laguna, Philippinen, 4027
- GSK Investigational Site
-
Makati City, Philippinen
- GSK Investigational Site
-
Manila, Philippinen, 1000
- GSK Investigational Site
-
Manila, Philippinen
- GSK Investigational Site
-
Maybunga, Pasig City, Philippinen
- GSK Investigational Site
-
Muntinlupa City, Philippinen, 1780
- GSK Investigational Site
-
Pasay City, Philippinen
- GSK Investigational Site
-
Pasig City, Metro Manila, Philippinen, 1600
- GSK Investigational Site
-
Quezon City, Philippinen, 1113
- GSK Investigational Site
-
Quezon City, Philippinen
- GSK Investigational Site
-
Quezon City, Philippinen, 1102
- GSK Investigational Site
-
Talaba IV, Bacoor, Cavite, Philippinen
- GSK Investigational Site
-
Taytay, Rizal, Philippinen
- GSK Investigational Site
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
1 Monat bis 5 Monate (Kind)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Filipino subjects aged at least 6 weeks at the time of first vaccination
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Cohort Group
Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
|
Two doses of the oral vaccine
Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea).
Zeitfenster: 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.
|
During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2).
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Zeitfenster: During the 15-day solicited follow-up period (Day 0 to Day 14) after each vaccine dose (Dose 1 and Dose 2).
|
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.
|
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)
Zeitfenster: During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose.
|
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.
|
During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose.
|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
Zeitfenster: Throughout the study period (Day 0 to one month post-Dose 2).
|
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.
|
Throughout the study period (Day 0 to one month post-Dose 2).
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
16. November 2006
Primärer Abschluss (Tatsächlich)
31. März 2010
Studienabschluss (Tatsächlich)
17. Juli 2010
Studienanmeldedaten
Zuerst eingereicht
17. Juli 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. Juli 2006
Zuerst gepostet (Schätzen)
18. Juli 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
16. März 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
23. Februar 2021
Zuletzt verifiziert
1. Februar 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 103366
- 2012-004039-21 (EudraCT-Nummer)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .