ID
37881
Descrição
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 concomitant vaccinations the subject received in the 30 days preceding the first dose of the study vaccines and during the entire study period and is to be filled in at the Interim Analysis at/after Visit 6 and at the End of Study Analysis at/after Visit 10. OPV and measles vaccinations administered during the entire study period are to be recorded in the “Protocol Required Concomitant Vaccination” form.
Palavras-chave
Versões (1)
- 28/08/2019 28/08/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
28 de agosto de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010
Concomitant Vaccination
- StudyEvent: ODM
Descrição
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Descrição
Any vaccine not foreseen in the study protocol administered during the period beginning 30 days preceding the first dose of the study vaccines and during the entire study period is to be recorded in this “concomitant medication/vaccination” form with trade name and/or generic name, route of administration and date(s) of administration. If yes, fill in the itemgroup below or each vaccine.
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C1948053
- UMLS CUI [1,5]
- C2348563
Descrição
Concomitant Vaccination Details
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C2348235
Descrição
Vaccination Trade Name/ (Generic) Name
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [2,1]
- C0042196
- UMLS CUI [2,2]
- C0592502
Descrição
Vaccination Administration Route
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042196
Descrição
Vaccination Administration Date
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0042196
Descrição
(for GSK)
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C2347796
Similar models
Concomitant Vaccination
- StudyEvent: ODM
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1948053 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,5])
C2347852 (UMLS CUI-2)
C2348235 (UMLS CUI-3)
C2360065 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0592502 (UMLS CUI [2,2])
C0042196 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C2347796 (UMLS CUI [1,2])