ID
37968
Beskrivning
Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains the Study Conclusion and is to be used twice - at the interim analysis at/after Visit 6 and at the final analysis at the end of the study (or if the subject has been withdrawn).
Nyckelord
Versioner (1)
- 2019-09-03 2019-09-03 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
3 september 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010
Study Conclusion
- StudyEvent: ODM
Beskrivning
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0042210
Beskrivning
If yes, please give the total number of SAE's in next item
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
if applicable
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Beskrivning
If Yes, please specify in next item
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C2347804
- UMLS CUI [1,3]
- C0347984
Beskrivning
Specify elimination criteria during study
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0680251
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C2347804
Beskrivning
If yes, fill in the remaining items in this itemgroup. If no, skip the rest of this itemgroup. Note for the interim analysis timepoint: A subject is withdrawn from the interim analysis if he/she did not come for the interim analysis timepoint visit.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
select one For SAE, Please complete and submit SAE report, and specify SAE No. For AEX/NSAE: Please complete Non-serious Adverse Event section, and please specify AE No. or solicited AE code for Protocol Violation, please specify For other, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205164
Beskrivning
also complete and submit SAE report
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beskrivning
also complete Non-serious Adverse Event form provide AE Number or solicited AE code (next item)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beskrivning
also complete Non-serious Adverse Event form provide AE Number or solicited AE code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1517001
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0600091
Beskrivning
Specify protocol violation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Beskrivning
Specify other reason for withdrawal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205164
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C1521902
Beskrivning
Who made withdrawal decision?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Beskrivning
Date of last contact
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1705415
Beskrivning
If no, please give details within the Adverse Events section
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0805839
Beskrivning
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
"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."
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigators signature Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2346576
Beskrivning
Investigator's name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Study Conclusion
- StudyEvent: ODM
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C1519255 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0680251 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
C0679006 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1705415 (UMLS CUI [1,3])
C0805839 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])