ID

42534

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. Elimination Criteria should be checked at each visit subsequent to the first visit. If any become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject’s evaluability in the according-to-protocol (ATP) analysis. Please note that informed consent has to be obtained prior to any study procedure.

Link

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

Keywords

Versions (1)
  1. 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

Elimination Criteria

1 forms  
  1. StudyEvent: ODM
    1. Elimination Criteria
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit number
Description

Visit number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Elimination Criteria
Description

Elimination Criteria

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0347984
UMLS CUI-3
C0008976
A: Administration of a vaccine (except tetanus toxoid) not foreseen by the study protocol during the period starting from 30 days before Dose 1 and ending 30 days after Dose 3.
Description

Administration of vaccines not indicated by study protocol during clinical trial period | except for tetanus vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C2347804
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0039620
B: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the study period.
Description

Investigational drug or investigational vaccine during clinical trial period | except for study vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C2347804
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3854006
C: Administration of immunoglobulins and/or any blood products during the study period.
Description

Immunoglobulins | blood products during clinical trial period

Data type

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C2347804
D: Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period (for corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Description

Chronic immunosuppressive agents or biological response modifiers during clinical trial period | except for inhaled steroids | except for topical steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C2347804
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2065041
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2064827
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Similar models

Elimination Criteria

1 forms
  1. StudyEvent: ODM
    1. Elimination Criteria
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])
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit Type
Code List
Visit number
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
CL Item
Visit 7 (7)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Elimination Criteria
C0680251 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Administration of vaccines not indicated by study protocol during clinical trial period | except for tetanus vaccine
Item
A: Administration of a vaccine (except tetanus toxoid) not foreseen by the study protocol during the period starting from 30 days before Dose 1 and ending 30 days after Dose 3.
boolean
C0042210 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
C1705847 (UMLS CUI [2,1])
C0039620 (UMLS CUI [2,2])
Investigational drug or investigational vaccine during clinical trial period | except for study vaccine
Item
B: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0042210 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C3854006 (UMLS CUI [3,2])
Immunoglobulins | blood products during clinical trial period
Item
C: Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0456388 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
Chronic immunosuppressive agents or biological response modifiers during clinical trial period | except for inhaled steroids | except for topical steroids
Item
D: Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period (for corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C2065041 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2064827 (UMLS CUI [4,2])
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