ID
36824
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 2.
Link
https://clinicaltrials.gov/ct2/show/NCT00323622
Trefwoorden
Versies (4)
- 12-12-18 12-12-18 -
- 06-06-19 06-06-19 -
- 12-06-19 12-06-19 -
- 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
Medication - Interim Analysis
- StudyEvent: ODM
Beschrijving
Medication
Alias
- UMLS CUI-1
- C0013227
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Concomitant medication details
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Trade/Generic Name
Datatype
text
Alias
- UMLS CUI [1]
- C0592503
- UMLS CUI [2]
- C0592502
Beschrijving
Indication
Datatype
text
Alias
- UMLS CUI [1]
- C3146298
Beschrijving
Prophylactic?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0199176
Beschrijving
Total daily dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0439810
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Medication start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C2347852
Beschrijving
Medication end date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C2347852
Beschrijving
Ongoing?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0549178
- UMLS CUI [1,2]
- C2347852
Similar models
Medication - Interim Analysis
- StudyEvent: ODM
C0592502 (UMLS CUI [2])
C0439810 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])