ID

36758

Beschrijving

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 1.

Link

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

Trefwoorden

  1. 11-12-18 11-12-18 -
  2. 05-06-19 05-06-19 -
  3. 06-06-19 06-06-19 - Sarah Riepenhausen
Houder van rechten

GSK group of companies

Geüploaded op

6 juni 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039

Visit 1: Eligibility Criteria

Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Eligibility Check
Beschrijving

Eligibility Check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Beschrijving

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Completion of Visit 7, Month 21 of Malaria-026
Beschrijving

Completion of last visit of previous study

Datatype

boolean

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C2242969
Written informed consent obtained from the parent(s) or guardian(s) of the subject
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Planned use of any investigational or non-registered drug or vaccine during the study period
Beschrijving

Planned use of investigational or non-registered drug/vaccine during study period

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C1301732
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0042210
UMLS CUI [2,4]
C0347984
UMLS CUI [2,5]
C2347804
Simultaneous participation in any other clinical trial
Beschrijving

Simultaneous other clinical trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348568

Similar models

Visit 1: Eligibility Criteria

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Entry criteria met
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Completion of last visit of previous study
Item
Completion of Visit 7, Month 21 of Malaria-026
boolean
C0805732 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C2242969 (UMLS CUI [1,4])
Informed Consent
Item
Written informed consent obtained from the parent(s) or guardian(s) of the subject
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Planned use of investigational or non-registered drug/vaccine during study period
Item
Planned use of any investigational or non-registered drug or vaccine during the study period
boolean
C1301732 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C1301732 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
C0347984 (UMLS CUI [2,4])
C2347804 (UMLS CUI [2,5])
Simultaneous other clinical trial
Item
Simultaneous participation in any other clinical trial
boolean
C0205394 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial