ID
37872
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 information on protocol-required concomitant vaccinations, which are OPV given at Visits 1, 2, 3 and 8, as well as Measles Vaccine given at Visits 5 and 8 (identical for all cohorts). There is a different form for concomitant vaccinations not outlined in the study protocol.
Keywords
Versions (1)
- 8/28/19 8/28/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 28, 2019
DOI
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License
Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010
Protocol required concomitant vaccinations
- StudyEvent: ODM
Description
Protocol required Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C2348563
Description
Fill in this entire item group once per vaccination. OPV is given at Visits 1, 2, 3 and 8. Measles Vaccine is given at Visits 5 and 8.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
Description
If Yes, please complete vaccination date if different from visit date. If Yes is ticked, the above vaccine is NOT to be reported again in the Concomitant Vaccination form. Any other vaccines administered during the study period are to be recorded in the Concomitant Vaccination form.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2348563
- UMLS CUI [1,4]
- C0884358
Description
complete only if different from visit date
Data type
date
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0011008
Similar models
Protocol required concomitant vaccinations
- StudyEvent: ODM
C2347852 (UMLS CUI-2)
C2348563 (UMLS CUI-3)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0884358 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])