ID
37889
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 non-serious adverse events other than the solicited adverse events, which are recorded in a different form, occuring up to 30 days post vaccination. Please report serious adverse events only on the Serious Adverse Event (SAE) reports. This NSAE form is to be filled in at the Interim Analysis at/after Visit 6 and the End of Study Analysis at/after Visit 10.
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
NSAE (unsolicited)
- StudyEvent: ODM
Descrição
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Descrição
If yes, fill in the next itemgroup once per NSAE.
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0332282
- UMLS CUI [1,3]
- C0042196
- UMLS CUI [2,1]
- C1705847
- UMLS CUI [2,2]
- C1517001
- UMLS CUI [2,3]
- C0877248
Descrição
Non-Serious Adverse Events Details
Alias
- UMLS CUI-1
- C1518404
- UMLS CUI-2
- C2348235
Descrição
AE No
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Descrição
Non-Serious Adverse Event Description
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0678257
Descrição
if at administration site, fill in next item
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0450429
Descrição
Non-Serious Adverse Event vaccine administration site
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C2368628
Descrição
(for GSK)
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C2347796
- UMLS CUI [1,2]
- C0947611
Descrição
Date Non-Serious Adverse Event Started
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Descrição
Non-Serious Adverse Event Start Date immediately post vaccination
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0205253
- UMLS CUI [1,4]
- C0687676
- UMLS CUI [1,5]
- C0042196
Descrição
Date Non-Serious Adverse Event Stopped
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Descrição
1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1710066
Descrição
Is there a reasonable possibility that the AE may have been caused by the investigational product? NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event.
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descrição
Not recovered / Not resolved: AE is ongoing at the time the subject completes the study or becomes lost to follow-up
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Similar models
NSAE (unsolicited)
- StudyEvent: ODM
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
C0877248 (UMLS CUI [2,3])
C2348235 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,5])
C0806020 (UMLS CUI [1,2])
C1710066 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])