ID
37946
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 an additional Study Continuation Check that is only to be used at Visit 1 in the HIV-positive and HIV-negative, HIV-exposed cohorts (i.e. those infants who had an additional Screening Visit). All cohorts have a more comprehensive Study Continuation Form that is to be used from Visit 2 onwards.
Keywords
Versions (1)
- 9/2/19 9/2/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 2, 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
Study Continuation Visit 1
- StudyEvent: ODM
Description
Study Continuation
Alias
- UMLS CUI-1
- C0805733
- UMLS CUI-2
- C0008976
Description
If yes, complete the appropriate forms. If no, please select the ONE most appropriate reason and skip the following forms of this visit.
Data type
boolean
Alias
- UMLS CUI [1]
- C0805733
Description
If SAE, please complete and submit SAE report, and specify SAE No. If AE, please complete Non-serious Adverse Event form, and specify AE No. If Other Reason, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0008976
Description
if SAE major reason for non-continuation
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
if AE major reason for non-continuation
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
e.g.: consent withdrawal, Protocol violation, …
Data type
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C0457454
- UMLS CUI [1,4]
- C0008976
Description
Who made discontinuation decision
Data type
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0679006
Similar models
Study Continuation Visit 1
- StudyEvent: ODM
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])