ID
42538
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. The vaccine administration form should be completed at every vaccination visit (visits 2, 4, and 5 for vaccine doses 1, 2, and 3 respectively). If any adverse events occurred during the immediate post-vaccination time (60 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event report with the immediate post-vaccination observation. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section. Please 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
Vaccine Administration
- StudyEvent: ODM
Description
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Description
Fill in only if different from visit date.
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2368628
Description
Body temperature before vaccination
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0332152
Description
Please consider axillary measurement [A] to be the preferable route.
Data type
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C0449687
Description
Only one box must be ticked by vaccine. If replacement vial [R], please specify the replacement vial number below. If wrong vial number [W], please specify the wrong number below. If not administered [N], please fill reasons in the next item group.
Data type
text
Alias
- UMLS CUI [1]
- C2368628
Description
Vaccine administration vial device replacement identifier
Data type
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0184301
- UMLS CUI [1,3]
- C0559956
- UMLS CUI [1,4]
- C0600091
Description
Vaccine administration vial device wrong identifier
Data type
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0184301
- UMLS CUI [1,3]
- C3827420
- UMLS CUI [1,4]
- C0600091
Description
Side / site / route according to protocol: Left / Deltoid / I.M.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Description
Side drug administration of vaccine
Data type
text
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C2368628
Description
Anatomic site administration of vaccine
Data type
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C2368628
Description
Route administration of vaccine
Data type
text
Alias
- UMLS CUI [1,1]
- C0449444
- UMLS CUI [1,2]
- C2368628
Description
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Description
Non-administration of vaccine primary reason
Data type
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C0566251
- UMLS CUI [1,4]
- C0205225
Description
If serious adverse event [SAE], please also complete and submit SAE report.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1521902
Description
OR specify solicited adverse event code in the following item. If non-serious adverse event [AEX], please also complete the non-serious adverse event section.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1521902
Description
OR specify non-serious adverse event number in the previous item. If non-serious adverse event [AEX], please also complete the non-serious adverse event section.
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1517001
- UMLS CUI [1,3]
- C0805701
- UMLS CUI [1,4]
- C1521902
Description
Non-administration of vaccine other reason to specify | consent withdrawal | protocol violation
Data type
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C0566251
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C1521902
- UMLS CUI [2]
- C1707492
- UMLS CUI [3]
- C1709750
Description
Non-administration decision maker
Data type
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C0679006
Similar models
Vaccine Administration
- StudyEvent: ODM
C2368628 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0449687 (UMLS CUI [1,4])
C0184301 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
C0184301 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C1517001 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
C1707492 (UMLS CUI [2])
C1709750 (UMLS CUI [3])
C1272696 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])