ID

42533

Beschreibung

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. Randomisation / Treatment Allocation takes place at visit 2 prior to the first vaccination. The subsequent record treatment number should documented at visit 2. Information on the subject's demographics, body weight, and HBV immunization status (incl. vaccination dates) should also be recorded at clinical visit 2. Please note that informed consent has to be obtained prior to any study procedure.

Link

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

Stichworte

Versionen (1)
  1. 24.08.21 24.08.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

24. August 2021

DOI

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Lizenz

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

Englisch

Demographics, Randomisation, Weight, and HBV Immunization Status

1 Formulare  
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Randomisation / Treatment allocation
Beschreibung

Randomisation / Treatment allocation

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C1522541
Record treatment number
Beschreibung

Treatment number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
Body weight
Beschreibung

Body weight

Alias
UMLS CUI-1
C0005910
Body weight
Beschreibung

Body weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
HBV immunization status
Beschreibung

HBV immunization status

Alias
UMLS CUI-1
C0552506
UMLS CUI-2
C0019163
Was Hepatitis B vaccine administered?
Beschreibung

If Yes, please provide the dates of the first, second, and third vaccination in the items below.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2240392
UMLS CUI [1,2]
C2368628
If Yes, date of 1st vaccination
Beschreibung

Date in time hepatitis B vaccine administration (1st)

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2240392
UMLS CUI [1,3]
C2368628
UMLS CUI [1,4]
C0205435
If Yes, date of 2nd vaccination
Beschreibung

Date in time hepatitis B vaccine administration (2nd)

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2240392
UMLS CUI [1,3]
C2368628
UMLS CUI [1,4]
C0205436
If Yes, date of 3rd vaccination
Beschreibung

Date in time hepatitis B vaccine administration (3rd)

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2240392
UMLS CUI [1,3]
C2368628
UMLS CUI [1,4]
C0205437
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Ähnliche Modelle

Demographics, Randomisation, Weight, and HBV Immunization Status

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Demographics
C0011298 (UMLS CUI-1)
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 Group
Randomisation / Treatment allocation
C0034656 (UMLS CUI-1)
C1522541 (UMLS CUI-2)
Treatment number
Item
Record treatment number
integer
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Body weight
C0005910 (UMLS CUI-1)
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Item Group
HBV immunization status
C0552506 (UMLS CUI-1)
C0019163 (UMLS CUI-2)
Hepatitis B vaccine administered
Item
Was Hepatitis B vaccine administered?
boolean
C2240392 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Date in time hepatitis B vaccine administration (1st)
Item
If Yes, date of 1st vaccination
date
C0011008 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,4])
Date in time hepatitis B vaccine administration (2nd)
Item
If Yes, date of 2nd vaccination
date
C0011008 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C0205436 (UMLS CUI [1,4])
Date in time hepatitis B vaccine administration (3rd)
Item
If Yes, date of 3rd vaccination
date
C0011008 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C0205437 (UMLS CUI [1,4])
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