ID
37875
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 the subject's previous BCG and HBV vaccinations, as well as other previous vaccinations, and is to be filled in at Visit 1.
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
Vaccination History
- StudyEvent: ODM
Description
Vaccination history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0042196
Description
If yes, please complete the following item group (repeatedly if necessary)
Data type
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0004886
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C2347804
- UMLS CUI [2,1]
- C2368628
- UMLS CUI [2,2]
- C0474232
- UMLS CUI [2,3]
- C0332152
- UMLS CUI [2,4]
- C2347804
Description
If yes, please complete the following item group (repeatedly if necessary)
Data type
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
- UMLS CUI [2,1]
- C1705847
- UMLS CUI [2,2]
- C0004886
- UMLS CUI [3,1]
- C1705847
- UMLS CUI [3,2]
- C0474232
Description
Vaccination details
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C1522508
Description
Trade / Generic Name of vaccination
Data type
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0042196
Description
Route of vaccination
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Description
Dose Number of vaccination
Data type
integer
Alias
- UMLS CUI [1,1]
- C1115464
- UMLS CUI [1,2]
- C0042196
Description
Enter approximate date in case the exact date is unknown.
Data type
date
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0011008
Description
Comment for GSK
Data type
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0008961
Similar models
Vaccination History
- StudyEvent: ODM
C0004886 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C2368628 (UMLS CUI [2,1])
C0474232 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0004886 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0474232 (UMLS CUI [3,2])
C0042196 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])