ID
42535
Beschrijving
Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/NCT00307021. A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum malaria vaccine RTS,S/AS01E (0.5 mL dose) to RTS,S/AS02D (0.5 mL dose) administered IM according to a 0, 1, 2- month vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the vaccination period in the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit (visit code 21-25 following clinical visit 2; visit code 26-31 following clinical visit 4; visit code 32-37 following clinical visit 5). After completion of the vaccination period, field-worker visits (visit code 38-47) take place during months 4 to 13 of the single-blind phase. The 'General Medical History and Physical Examination' form should be filled in at Visit 2 (0-28 days after Visit 1). Please report medication(s) as specified in the protocol and fill in the medical section. Please note that informed consent has to be obtained prior to any study procedure.
Link
https://clinicaltrials.gov/ct2/show/NCT00307021
Trefwoorden
Versies (2)
- 24-08-21 24-08-21 -
- 24-08-21 24-08-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
24 augustus 2021
DOI
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Licentie
Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021
General Medical History and Physical Examination
- StudyEvent: ODM
Beschrijving
General Medical History | Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beschrijving
If yes, please give diagnosis and tick appropriate Past/Current box(es) in the following item group.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0521987
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
- UMLS CUI [2,1]
- C0037088
- UMLS CUI [2,2]
- C2347662
- UMLS CUI [2,3]
- C0332152
- UMLS CUI [2,4]
- C2347804
Beschrijving
General Medical History | Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beschrijving
MeDRA system organ class
Datatype
integer
Alias
- UMLS CUI [1]
- C2347091
Beschrijving
Diagnosis
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
Past diagnosis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C1444637
Beschrijving
Current diagnosis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0521116
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