ID
36811
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 document is to be completed at/after Visit 2.
Link
https://clinicaltrials.gov/ct2/show/NCT00323622
Trefwoorden
Versies (3)
- 12-12-18 12-12-18 -
- 06-06-19 06-06-19 -
- 12-06-19 12-06-19 -
Houder van rechten
GSK group of companies
Geüploaded op
12 juni 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039
Study Conclusion - Interim Analysis
- StudyEvent: ODM
Beschrijving
Occurrence of serious adverse events
Alias
- UMLS CUI-1
- C1519255
Beschrijving
SAEs recorded up to visit 7, month 21 of Malaria-026 to be recorded in Malaria-026; SAEs recorded 1 day after Visit 7, month 21 to be recorded in Malaria-039 SAE forms.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332282
- UMLS CUI [1,3]
- C2242969
Beschrijving
Number of SAEs in current trial
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347804
- UMLS CUI [1,3]
- C0449788
Beschrijving
Subject Withdrawal
Alias
- UMLS CUI-1
- C0422727
Beschrijving
A subject is withdrawn from the interim analysis if he/she did not come for the interim analysis timepoint visit
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
tick one box only
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
Beschrijving
In case of death, please specify SAE number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C2349022
Beschrijving
Please also complete and submit SAE report
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349022
Beschrijving
In case of protocol violation, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beschrijving
specify other reason for withdrawal
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0566251
- UMLS CUI [1,4]
- C0422727
Beschrijving
Withdrawal Decision
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Beschrijving
Date of last contact
Datatype
date
Alias
- UMLS CUI [1]
- C0805839
Beschrijving
If No, please give details in Adverse Events section
Datatype
text
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
- UMLS CUI [1,3]
- C0805839
Beschrijving
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Investigator's confirmation
Datatype
date
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0008961
Beschrijving
Investigator's signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator's name (in print)
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Study Conclusion - Interim Analysis
- StudyEvent: ODM
C0332282 (UMLS CUI [1,2])
C2242969 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,3])
C2349022 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0422727 (UMLS CUI [1,4])
C0679006 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
C0008961 (UMLS CUI [1,2])