ID
37968
Beschrijving
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).
Trefwoorden
Versies (1)
- 03-09-19 03-09-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
3 september 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010
Study Conclusion
- StudyEvent: ODM
Beschrijving
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0042210
Beschrijving
If yes, please give the total number of SAE's in next item
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
if applicable
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Beschrijving
If Yes, please specify in next item
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C2347804
- UMLS CUI [1,3]
- C0347984
Beschrijving
Specify elimination criteria during study
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0680251
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C2347804
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205164
Beschrijving
also complete and submit SAE report
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschrijving
also complete Non-serious Adverse Event form provide AE Number or solicited AE code (next item)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschrijving
also complete Non-serious Adverse Event form provide AE Number or solicited AE code
Datatype
text
Alias
- UMLS CUI [1,1]
- C1517001
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0600091
Beschrijving
Specify protocol violation
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Beschrijving
Specify other reason for withdrawal
Datatype
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
Beschrijving
Who made withdrawal decision?
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Beschrijving
Date of last contact
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1705415
Beschrijving
If no, please give details within the Adverse Events section
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0805839
Beschrijving
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
"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."
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigators signature Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2346576
Beschrijving
Investigator's name
Datatype
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])