ID
37968
Description
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).
Mots-clés
Versions (1)
- 03/09/2019 03/09/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
3 septembre 2019
DOI
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Licence
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
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0042210
Description
If yes, please give the total number of SAE's in next item
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
if applicable
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Description
If Yes, please specify in next item
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C2347804
- UMLS CUI [1,3]
- C0347984
Description
Specify elimination criteria during study
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0680251
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C2347804
Description
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.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0422727
Description
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
Type de données
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205164
Description
also complete and submit SAE report
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
also complete Non-serious Adverse Event form provide AE Number or solicited AE code (next item)
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
also complete Non-serious Adverse Event form provide AE Number or solicited AE code
Type de données
text
Alias
- UMLS CUI [1,1]
- C1517001
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0600091
Description
Specify protocol violation
Type de données
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Description
Specify other reason for withdrawal
Type de données
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
Description
Who made withdrawal decision?
Type de données
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Description
Date of last contact
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1705415
Description
If no, please give details within the Adverse Events section
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0805839
Description
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
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."
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigators signature Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2346576
Description
Investigator's name
Type de données
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])