ID

32447

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 for basic demographic informations about the patient. It 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

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Lizenz

Creative Commons BY-NC 3.0
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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

Englisch

Demographics

1 Formulare  
  1. StudyEvent: ODM
    1. Demographics
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
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C1704791
center number
Beschreibung

Center number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
If other race, please specify
Beschreibung

Other Race

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0034510
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Informed Consent
Beschreibung

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Beschreibung

I certify that Informed Consent has been obtained prior to any study procedure.

Datentyp

date

Alias
UMLS CUI [1]
C2985782
UMLS CUI [2]
C0021430
Randomization/Treatment Allocation
Beschreibung

Randomization/Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record Treatment Number
Beschreibung

Record Treatment Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
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Ähnliche Modelle

Demographics

1 Formulare
  1. StudyEvent: ODM
    1. Demographics
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
C1704791 (UMLS CUI-1)
Center number
Item
center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
male (m)
CL Item
female (f)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
African Heritage / African American (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other, specify (99)
Other Race
Item
If other race, please specify
text
C0205394 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent plus Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
Randomization/Treatment Allocation
C0034656 (UMLS CUI-1)
Record Treatment Number
Item
Record Treatment Number
integer
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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