ID

42534

Descripción

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

Palabras clave

Versiones (1)
  1. 24/8/21 24/8/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

24 de agosto de 2021

DOI

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Licencia

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

Inglés

Elimination Criteria

1 formularios  
  1. StudyEvent: ODM
    1. Elimination Criteria
Administrative Documentation
Descripción

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Visit number
Descripción

Visit number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1549755
Date of visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Elimination Criteria
Descripción

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.
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Immunoglobulins | blood products during clinical trial period

Tipo de datos

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).
Descripción

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

Tipo de datos

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 formularios
  1. StudyEvent: ODM
    1. Elimination Criteria
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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