ID

36824

Beschreibung

Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT00323622 This form is to be completed at Visit 2.

Link

https://clinicaltrials.gov/ct2/show/NCT00323622

Stichworte

Versionen (4)
  1. 12.12.18 12.12.18 -
  2. 06.06.19 06.06.19 -
  3. 12.06.19 12.06.19 -
  4. 12.06.19 12.06.19 -
Rechteinhaber

GSK group of companies

Hochgeladen am

12. Juni 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039

Englisch

Medication - Interim Analysis

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C0013227
Have any medications/treatments been administered during study period?
Beschreibung

If yes, please complete the following table. At each study visit/contact, the investigator should question the subject's parents/guardians about any medication(s) taken. Record administration of immunosuppressants or other immune-modifying drugs during this period (for corticosteroids this means prednisone or equivalent,  0.5 mg/kg/day; inhaled or topical steroids need not be recorded), all immunoglobulins and blood products and any antimalarials

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant medication details
Beschreibung

Concomitant medication details

Alias
UMLS CUI-1
C2347852
Trade/Generic Name
Beschreibung

Trade/Generic Name

Datentyp

text

Alias
UMLS CUI [1]
C0592503
UMLS CUI [2]
C0592502
Medical Indication
Beschreibung

Indication

Datentyp

text

Alias
UMLS CUI [1]
C3146298
Prophylactic?
Beschreibung

Prophylactic?

Datentyp

boolean

Alias
UMLS CUI [1]
C0199176
Total daily dose
Beschreibung

Total daily dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Start date
Beschreibung

Medication start date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
End date
Beschreibung

Medication end date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
Ongoing at end of study?
Beschreibung

Ongoing?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C2347852
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Ähnliche Modelle

Medication - Interim Analysis

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Medication
C0013227 (UMLS CUI-1)
Concomitant medication
Item
Have any medications/treatments been administered during study period?
boolean
C2347852 (UMLS CUI [1])
Item Group
Concomitant medication details
C2347852 (UMLS CUI-1)
Trade/Generic Name
Item
Trade/Generic Name
text
C0592503 (UMLS CUI [1])
C0592502 (UMLS CUI [2])
Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1])
Prophylactic?
Item
Prophylactic?
boolean
C0199176 (UMLS CUI [1])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneus (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Medication start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medication end date
Item
End date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Ongoing?
Item
Ongoing at end of study?
boolean
C0549178 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
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