ID
37827
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 information on the microbiology results of the swab samples taken at Visits 1, 4, 5, 6, 7, 8, 9 and 10 (identical for all cohorts).
Trefwoorden
Versies (2)
- 26-08-19 26-08-19 -
- 03-09-19 03-09-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 augustus 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed, and HIV-negative infants - NCT00829010
Swab Microbiology
- StudyEvent: ODM
Beschrijving
Streptococcus pneumoniae
Alias
- UMLS CUI-1
- C0038410
Beschrijving
If positive, answer following questions in this itemgroup.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0025953
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [1,3]
- C0038410
Beschrijving
Please use codes below; specify "other" if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201217
- UMLS CUI [1,2]
- C0430402
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0201217
- UMLS CUI [1,4]
- C0430402
Beschrijving
Please use codes below; specify "other" if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201217
- UMLS CUI [1,2]
- C0430402
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0201217
- UMLS CUI [1,4]
- C0430402
Beschrijving
Please use codes below; specify "other" if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201217
- UMLS CUI [1,2]
- C0430402
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0201217
- UMLS CUI [1,4]
- C0430402
Beschrijving
If yes, give result in next item
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0368993
- UMLS CUI [1,2]
- C0884358
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C0368993
- UMLS CUI [1,2]
- C0456984
Beschrijving
Haemophilus influenzae
Alias
- UMLS CUI-1
- C0018483
Beschrijving
If positive, answer following questions in this itemgroup.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0025953
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [1,3]
- C0018483
Beschrijving
Please use codes below
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201217
- UMLS CUI [1,2]
- C0430402
Beschrijving
Please use codes below
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201217
- UMLS CUI [1,2]
- C0430402
Beschrijving
Please use codes below
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201217
- UMLS CUI [1,2]
- C0430402
Beschrijving
If yes, give result in next item
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0368993
- UMLS CUI [1,2]
- C0884358
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C0368993
- UMLS CUI [1,2]
- C0456984
Beschrijving
Staphylococcus aureus
Alias
- UMLS CUI-1
- C0038172
Beschrijving
Other bacteria
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C0004611
Beschrijving
If positive, answer following questions
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0025953
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0004611
Beschrijving
Moraxella catarrhalis detected?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0006132
- UMLS CUI [1,2]
- C0442726
Beschrijving
Group A Streptococcus detected?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0442726
- UMLS CUI [1,2]
- C1541907
Beschrijving
Normal flora detected?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0314761
- UMLS CUI [1,2]
- C0442726
Beschrijving
If yes, specify in next item
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0004611
- UMLS CUI [1,3]
- C0442726
Beschrijving
Specify other detected bacteria
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0442726
- UMLS CUI [1,3]
- C0004611
- UMLS CUI [1,4]
- C1521902
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
Investigator Signature Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Investigator Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
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