ID
42540
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. For all subjects enrolled, please complete the study conclusion form. The study conclusion should be documented subsequently to clinical visit 7 in separate forms for the double-blind and the single-blind phase respectively. The 'Status of Treatment Blind' item group only needs to be completed within the form for the double-blind phase. Note that informed consent has to be obtained prior to any study procedure.
Lien
https://clinicaltrials.gov/ct2/show/NCT00307021
Mots-clés
Versions (1)
- 24/08/2021 24/08/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
24 août 2021
DOI
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Licence
Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021
Study Conclusion
- StudyEvent: ODM
Description
Occurrence of Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Description
Serious adverse event during clinical trial period
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Description
Serious adverse event during clinical trial period count specification
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
- UMLS CUI [1,4]
- C0750480
- UMLS CUI [1,5]
- C1521902
Description
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Description
Only to be completed for the double-blind phase version of the form. If yes, complete date and tick one reason in the following items.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Description
Subject unblinding event record date
Type de données
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Description
Please tick one reason. If [9] other, please specify in the following item. Also complete Non-Serious Adverse Event section or a Serious Adverse Event report as appropriate.
Type de données
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205225
Description
Subject unblinding event record other reason to specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Description
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Elimination criteria during clinical trial period
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Description
Elimination criteria to specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Description
For the double-blind phase: Is the subject withdrawn from the double-blind phase? (A subject is withdrawn from the interim analysis if he/she did not come for the doublie blind phase - interim analysis timepoint visit.)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0422727
Description
Please tick one box only. If serious adverse event [SAE], please complete and submit SAE report.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205225
Description
Death-related serious adverse event number to specify
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0237753
- UMLS CUI [1,4]
- C1521902
Description
Serious adverse event number to specify
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1521902
Description
Protocol violation to specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Description
Withdrawal other reason to specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Description
Withdrawal decision maker
Type de données
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Description
Withdrawal date of last contact
Type de données
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0805839
Description
If no, please give details in Adverse Events section.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1142435
- UMLS CUI [1,3]
- C0805839
Description
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Alias
- UMLS CUI-1
- C2346576
Description
Investigator signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator signature date
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Study Conclusion
- StudyEvent: ODM
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
C2347038 (UMLS CUI-2)
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0679006 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])