ID

32440

Description

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 the general medical history of the patient and the results of a physical examination. It should be checked at first visit.

Link

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

Keywords

Versions (1)
  1. 11/1/18 11/1/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 1, 2018

DOI

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License

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

English

Medical History and Physical Examination

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
General Medical History, Phyiscal Examination
Description

General Medical History, Phyiscal Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
Description

Pre-existing conditions, signs or symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0521987
UMLS CUI [2]
C0037088
MedDRA SYSTEM ORGAN CLASS
Description

MedDRA System Organ Class

Data type

integer

Alias
UMLS CUI [1]
C2347091
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Past diagnosis
Description

Past

Data type

boolean

Alias
UMLS CUI [1,1]
C1444637
UMLS CUI [1,2]
C0011900
Current diagnosis
Description

Current

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0011900
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Similar models

Medical History and Physical Examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
General Medical History, Phyiscal Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Pre-existing conditions, signs or symptoms
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
boolean
C0521987 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
Item
MedDRA SYSTEM ORGAN CLASS
integer
C2347091 (UMLS CUI [1])
MedDRA System Organ Class
Code List
MedDRA SYSTEM ORGAN CLASS
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and (2)
CL Item
connective tissue (3)
CL Item
Cardiac (4)
CL Item
Vascular (5)
CL Item
Respiratory, thoracic and (6)
CL Item
mediastinal (7)
CL Item
Gastrointestinal (8)
CL Item
Hepatobiliary (9)
CL Item
Renal and urinary (10)
CL Item
Nervous system (11)
CL Item
Eye (12)
CL Item
Ear and labyrinth (13)
CL Item
Endocrine (14)
CL Item
Metabolism and nutrition (15)
CL Item
Blood and lymphatic system (16)
CL Item
Immune system (17)
CL Item
Infections and infestations (18)
CL Item
Neoplasms benign, malignant (19)
CL Item
and unspecified (20)
CL Item
Surgical and medical (21)
CL Item
procedures (22)
CL Item
Other (23)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Past
Item
Past diagnosis
boolean
C1444637 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Current
Item
Current diagnosis
boolean
C0521116 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
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