ID

37946

Beschrijving

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.

Trefwoorden

  1. 02-09-19 02-09-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

2 september 2019

DOI

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Licentie

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

Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Beschrijving

To be used for these two cohorts only.

Datatype

integer

Alias
UMLS CUI [1]
C0599755
Date of Visit
Beschrijving

Visit 1 is scheduled at 6-10 weeks of life.

Datatype

date

Alias
UMLS CUI [1]
C1320303
Study Continuation
Beschrijving

Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for this visit?
Beschrijving

If yes, complete the appropriate forms. If no, please select the ONE most appropriate reason and skip the following forms of this visit.

Datatype

boolean

Alias
UMLS CUI [1]
C0805733
reason for study non-continuation
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Specify SAE Number
Beschrijving

if SAE major reason for non-continuation

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Specify AE Number
Beschrijving

if AE major reason for non-continuation

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Specify other reason for non-continuation
Beschrijving

e.g.: consent withdrawal, Protocol violation, …

Datatype

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0457454
UMLS CUI [1,4]
C0008976
Please select who made the decision
Beschrijving

Who made discontinuation decision

Datatype

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006

Similar models

Study Continuation Visit 1

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Code List
Cohort
CL Item
HIV-pos. (1)
CL Item
HIV-neg. exposed (2)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Returned for this visit?
Item
Did the subject return for this visit?
boolean
C0805733 (UMLS CUI [1])
Item
reason for study non-continuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
reason for study non-continuation
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
Specify SAE Number
Item
Specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify AE Number
Item
Specify AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify other reason for study discontinuation
Item
Specify other reason for non-continuation
text
C3840932 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Item
Please select who made the decision
text
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Code List
Please select who made the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)

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