ID

37889

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 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.

Keywords

Versions (1)
  1. 8/28/19 8/28/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 28, 2019

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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

English

NSAE (unsolicited)

1 forms  
  1. StudyEvent: ODM
    1. NSAE (unsolicited)
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Description

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Visit Type
Description

Visit Type

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Description

If yes, fill in the next itemgroup once per NSAE.

Data type

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
Non-Serious Adverse Events Details
Description

Non-Serious Adverse Events Details

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C2348235
AE No
Description

AE No

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Non-Serious Adverse Event Description
Description

Non-Serious Adverse Event Description

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Non-Serious Adverse Event location
Description

if at administration site, fill in next item

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0450429
Non-Serious Adverse Event vaccine administration site
Description

Non-Serious Adverse Event vaccine administration site

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C2368628
Sponsor Comment
Description

(for GSK)

Data type

text

Alias
UMLS CUI [1,1]
C2347796
UMLS CUI [1,2]
C0947611
Date Non-Serious Adverse Event Started
Description

Date Non-Serious Adverse Event Started

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)
Description

Non-Serious Adverse Event Start Date immediately post vaccination

Data type

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
Date Non-Serious Adverse Event Stopped
Description

Date Non-Serious Adverse Event Stopped

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-Serious Adverse Event Intensity
Description

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).

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710066
Relationship to investigational products:
Description

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.

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Non-Serious Adverse Event Outcome
Description

Not recovered / Not resolved: AE is ongoing at the time the subject completes the study or becomes lost to follow-up

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
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Similar models

NSAE (unsolicited)

1 forms
  1. StudyEvent: ODM
    1. NSAE (unsolicited)
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Cohort
Code List
Cohort
CL Item
HIV-pos. (1)
CL Item
HIV-neg. exposed (2)
CL Item
HIV-neg. unexposed, 3+1 schedule (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (5)
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Interim Analysis at/after Visit 6 (1)
CL Item
End of Study Analysis at/after Visit 10 (2)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
NSAE after vaccination (except solicited AEs)?
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1,1])
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])
Item Group
Non-Serious Adverse Events Details
C1518404 (UMLS CUI-1)
C2348235 (UMLS CUI-2)
AE No
Item
AE No
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-Serious Adverse Event Description
Item
Non-Serious Adverse Event Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event location
text
C1518404 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Non-Serious Adverse Experiences location
Code List
Non-Serious Adverse Event location
CL Item
Administration site (L)
CL Item
Non-administration site (G)
Item
Non-Serious Adverse Event vaccine administration site
text
C1518404 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Non-Serious Adverse Experiences location
Code List
Non-Serious Adverse Event vaccine administration site
CL Item
10Pn-PD-DiT vaccine (234)
CL Item
DTPw-HBV/Hib vaccine (94)
CL Item
both vaccine sites (B)
Sponsor Comment
Item
Sponsor Comment
text
C2347796 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Date Non-Serious Adverse Event Started
Item
Date Non-Serious Adverse Event Started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-Serious Adverse Event Start Date immediately post vaccination
Item
Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)
boolean
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,5])
Date Non-Serious Adverse Event Stopped
Item
Date Non-Serious Adverse Event Stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Intensity
integer
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Intensity
Code List
Non-Serious Adverse Event Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational products:
Item
Relationship to investigational products:
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Non-Serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Experience Outcome
Code List
Non-Serious Adverse Event Outcome
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ not resolved (3)
CL Item
Recovered with sequelae/ Resolved with sequelae (4)
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