ID
36768
Descripción
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
Palabras clave
Versiones (2)
- 11/12/18 11/12/18 -
- 6/6/19 6/6/19 -
Titular de derechos de autor
GSK group of companies
Subido en
6 de junio de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039
Visit 2: Study Continuation Check
- StudyEvent: ODM
Descripción
Check for Study Continuation
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C0805733
Descripción
If Yes, please complete the next pages. If No, Please tick the ONE most appropriate reason and skip the following pages of this visit, and please tick who took the decision.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0805733
- UMLS CUI [1,3]
- C0008976
Descripción
Reason for discontinuation
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0008976
Descripción
complete the Serious Adverse Event form
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0600091
- UMLS CUI [1,2]
- C1519255
Descripción
e.g.: consent withdrawal, Protocol violation, non-serious adverse event …
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C1521902
Descripción
Discontinuation decision
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0679006
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0008976
Similar models
Visit 2: Study Continuation Check
- StudyEvent: ODM
C0805733 (UMLS CUI-2)
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])