ID

42536

Description

Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/NCT00307021. A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum malaria vaccine RTS,S/AS01E (0.5 mL dose) to RTS,S/AS02D (0.5 mL dose) administered IM according to a 0, 1, 2- month vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. The 'General Medical History and Physical Examination' form should be filled in at Visit 2 (0-28 days after Visit 1). Please report medication(s) as specified in the protocol and fill in the medical section. Please note that informed consent has to be obtained prior to any study procedure.

Link

https://clinicaltrials.gov/ct2/show/NCT00307021

Keywords

Versions (2)
  1. 8/24/21 8/24/21 -
  2. 8/24/21 8/24/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 24, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

English

General Medical History and Physical Examination

1 forms  
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
General Medical History | Physical Examination
Description

General Medical History | Physical 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

If yes, please give diagnosis and tick appropriate Past/Current box(es) in the following item group.

Data type

boolean

Alias
UMLS CUI [1,1]
C0521987
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C2347662
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C2347804
General Medical History | Physical Examination
Description

General Medical History | Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
MedDRA system organ class
Description

MeDRA 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 diagnosis

Data type

boolean

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

Current diagnosis

Data type

boolean

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

General Medical History and Physical Examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
General Medical History | Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Pre-existing conditions, signs or symptoms before clinical trial period
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
boolean
C0521987 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0037088 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
Item Group
General Medical History | Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Item
MedDRA system organ class
integer
C2347091 (UMLS CUI [1])
MeDRA system organ class
Code List
MedDRA system organ class
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and connective tissue (2)
CL Item
Cardiac (3)
CL Item
Vascular (4)
CL Item
Respiratory, thoracic and mediastinal (5)
CL Item
Gastrointestinal (6)
CL Item
Hepatobiliary (7)
CL Item
Renal and urinary (8)
CL Item
Nervous system (9)
CL Item
Eye (10)
CL Item
Ear and labyrinth (11)
CL Item
Endocrine (12)
CL Item
Metabolism and nutrition (13)
CL Item
Blood and lymphatic system (14)
CL Item
Immune system (incl allergies, autoimmune disorders) (15)
CL Item
Infections and infestations (16)
CL Item
Neoplasmas benign, malignant and unspecified (incl cysts, polyps) (17)
CL Item
Surgical and medical procedures (18)
CL Item
Other (99)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Past diagnosis
Item
Past diagnosis
boolean
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Current diagnosis
Item
Current diagnosis
boolean
C0011900 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
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