ID
42540
Beschreibung
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00307021
Stichworte
Versionen (1)
- 24.08.21 24.08.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. August 2021
DOI
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Lizenz
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
Beschreibung
Occurrence of Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious adverse event during clinical trial period
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Beschreibung
Serious adverse event during clinical trial period count specification
Datentyp
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
Beschreibung
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Beschreibung
Subject unblinding event record date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205225
Beschreibung
Subject unblinding event record other reason to specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beschreibung
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Elimination criteria during clinical trial period
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Beschreibung
Elimination criteria to specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Beschreibung
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.)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschreibung
Please tick one box only. If serious adverse event [SAE], please complete and submit SAE report.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205225
Beschreibung
Death-related serious adverse event number to specify
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0237753
- UMLS CUI [1,4]
- C1521902
Beschreibung
Serious adverse event number to specify
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1521902
Beschreibung
Protocol violation to specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Beschreibung
Withdrawal other reason to specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beschreibung
Withdrawal decision maker
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Beschreibung
Withdrawal date of last contact
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0805839
Beschreibung
If no, please give details in Adverse Events section.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1142435
- UMLS CUI [1,3]
- C0805839
Beschreibung
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
Beschreibung
Investigator signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Investigator signature date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
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])