ID

32454

Beskrivning

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 contains information about the confirmation testing of the subject for HIV. It should be checked at Visit 4 and is part of study amendment 1.

Länk

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

Nyckelord

Versioner (1)
  1. 2018-11-01 2018-11-01 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

1 november 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

Engelsk

HIV Confirmation Testing

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
HIV Confirmatory Test
Beskrivning

HIV Confirmatory Test

Alias
UMLS CUI-1
C1321876
Was a blood sample taken for the confirmatory HIV testing ?
Beskrivning

Blood Sample for HIV Testing

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1321876
Blood sample date
Beskrivning

If blood sample was taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
PCR testing result
Beskrivning

PCR testing result

Datatyp

integer

Alias
UMLS CUI [1,1]
C0032520
UMLS CUI [1,2]
C1274040
Tillbaka till toppen

Similar models

HIV Confirmation Testing

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
HIV Confirmatory Test
C1321876 (UMLS CUI-1)
Item
Was a blood sample taken for the confirmatory HIV testing ?
integer
C0005834 (UMLS CUI [1,1])
C1321876 (UMLS CUI [1,2])
Blood Sample for HIV Testing
Code List
Was a blood sample taken for the confirmatory HIV testing ?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Blood sample date
Item
Blood sample date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
PCR testing result
integer
C0032520 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
PCR testing result
Code List
PCR testing result
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Unknown (3)
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial