ID
42542
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/guardians about any vaccination administered. Any vaccine not foreseen in the study protocol administered in the period beginning 30 days preceding each dose and ending 30 days after each dose is to be recorded with trade name, route of administration and date(s) of administration. Please ensure that all information on SAE pages is consistent with the information given on Concomitant Vaccination in the Case Report Form. 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
Concomitant Vaccination
- StudyEvent: ODM
Description
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Description
If yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date in the following item group.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C1948053
- UMLS CUI [1,5]
- C2348563
- UMLS CUI [2,1]
- C1705847
- UMLS CUI [2,2]
- C0042196
- UMLS CUI [2,3]
- C3854006
Description
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Description
Trade name | generic name concomitant vaccination
Data type
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C2347852
- UMLS CUI [2,1]
- C0592502
- UMLS CUI [2,2]
- C0042196
- UMLS CUI [2,3]
- C2347852
Description
Drug administration route concomitant vaccination
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C2347852
Description
Date of administration concomitant vaccination
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C2347852
Description
Clinical study sponsor comment
Data type
text
Alias
- UMLS CUI [1,1]
- C2347796
- UMLS CUI [1,2]
- C0947611
Similar models
Concomitant Vaccination
- StudyEvent: ODM
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1948053 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,5])
C1705847 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C3854006 (UMLS CUI [2,3])
C2347852 (UMLS CUI-2)
C0042196 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C0592502 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C2347852 (UMLS CUI [2,3])
C0042196 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,2])