ID

32437

Beschreibung

Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form asks, if a blood sample has been taken from the patient and should be checked at visit 1.

Link

https://clinicaltrials.gov/ct2/show/NCT00241644

Stichworte

Versionen (1)
  1. 01.11.18 01.11.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

1. November 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

Englisch

Laboratory Tests Visit 1

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Laboratory Tests
Beschreibung

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Beschreibung

2 ml in South Africa and 1 ml in Malawi for subset only (Amendment 4)

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Date of Blood Sample
Beschreibung

Please complete only if different from visit date:

Datentyp

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Medical History for HIV
Beschreibung

Medical History for HIV

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0019682
Has the subject been exposed to HIV?
Beschreibung

Subject exposed to HIV

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0332157
Was a HIV test performed at Visit 1?
Beschreibung

If yes, complete the specific HIV section.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321876
UMLS CUI [1,2]
C0262926
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Laboratory Tests Visit 1

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Blood Sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Blood Sample Date
Item
Date of Blood Sample
text
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Medical History for HIV
C0262926 (UMLS CUI-1)
C0019682 (UMLS CUI-2)
Subject exposed to HIV
Item
Has the subject been exposed to HIV?
boolean
C0019682 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
HIV Test
Item
Was a HIV test performed at Visit 1?
boolean
C1321876 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video