ID
42541
Description
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 double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. At each study visit/contact, the investigator should question the subject's parents/guardian about any medication(s) taken. A separate medication form for both double-blind and single-blind phase should be completed. Relevant medication for double-blind phase only: * All antipyretic, analgesic and antibiotic drugs administered at ANY time during the period starting with administration of each dose and ending 30 days after each dose are to be recorded with generic name of the medication (trade names are allowed for combination drugs, i.e., multi-component drugs), medical indication, total daily dose, route of administration, start and end dates of treatment. *Any concomitant medication administered prophylactically in anticipation of reaction to the vaccination must be recorded in the CRF with generic name of the medication (trade names are allowed for combination drugs only), total daily dose, route of administration, start and end dates of treatment and coded as ‘Prophylactic’. Relevant medication for both double-blind and single-blind phase: * Any treatments and/or medications which are listed as elimination criteria, e.g., any immunoglobulins, other blood products and any immune modifying drugs administered within three months preceding the first dose or at any time during the study period are to be recorded with generic name of the medication (trade names are allowed for combination drugs only), medical indication, total daily dose, route of administration, start and end dates of treatment. The time periods between which different classes of concomitant medication/treatment/vaccination must be recorded are summarized below: Relevant time periods for the double-blind phase: (1) 3 months prior to Dose 1 until Dose 1: *All treatments listed as elimination criteria (e.g. any immunoglobulins, other blood products and any immune modifying drugs) (2) Screening until 30 Days post Dose 3: *All antipyretic, analgesic, antibiotic and any treatments listed as elimination criteria (e.g. any immunoglobulins, other blood products and any immune modifying drugs) *All vaccinations (3) 31 Days post Dose 3 until Final Study Visit: *All treatments listed as elimination criteria (e.g. any immunoglobulins, other blood products and any immune modifying drugs) Relevant time periods for the single-blind phase: (1) Last visit for ADI until Final Study Visit: *All treatments listed as elimination criteria (e.g. any immunoglobulins, other blood products and any immune modifying drugs) Note that informed consent has to be obtained prior to any study procedure.
Link
https://clinicaltrials.gov/ct2/show/NCT00307021
Keywords
Versions (1)
- 8/24/21 8/24/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 24, 2021
DOI
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License
Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021
Medication
- StudyEvent: ODM
Description
Medication
Alias
- UMLS CUI-1
- C2347852
Description
Medication
Alias
- UMLS CUI-1
- C2347852
Description
Trade name | generic name pharmaceutical preparation
Data type
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [2,1]
- C0592502
- UMLS CUI [2,2]
- C0013227
Description
Pharmaceutical preparations prophylactic treatment vaccine reaction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0199176
- UMLS CUI [1,3]
- C0042210
- UMLS CUI [1,4]
- C0443286
Description
Pharmaceutical preparations daily dose total
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
- UMLS CUI [1,3]
- C0439810
Description
Drug administration route pharmaceutical preparation
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0013227
Description
Pharmaceutical preparations start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
Please indicate end date or tick the box in the following item if continuing at end of study.
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Tick box if continuing at end of study.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Description
Clinical study sponsor comment
Data type
text
Alias
- UMLS CUI [1,1]
- C2347796
- UMLS CUI [1,2]
- C0947611
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Medication
- StudyEvent: ODM
C0347984 (UMLS CUI [1,2])
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C0013227 (UMLS CUI [1,2])
C0592502 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0199176 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0443286 (UMLS CUI [1,4])
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C0439810 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
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