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37889

Beschreibung

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.

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  1. 28.08.19 28.08.19 -
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GlaxoSmithKline

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28. August 2019

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    10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010

    Englisch

    NSAE (unsolicited)

    1 Formulare  
    1. StudyEvent: ODM
      1. NSAE (unsolicited)
    Administrative data
    Beschreibung

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschreibung

    Clinical Trial Subject Unique Identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Cohort
    Beschreibung

    Cohort

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0599755
    Visit Type
    Beschreibung

    Visit Type

    Datentyp

    integer

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

    Date of Visit

    Datentyp

    date

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

    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?
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    Non-Serious Adverse Events Details

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

    AE No

    Datentyp

    integer

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

    Non-Serious Adverse Event Description

    Datentyp

    text

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

    if at administration site, fill in next item

    Datentyp

    text

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

    Non-Serious Adverse Event vaccine administration site

    Datentyp

    text

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

    (for GSK)

    Datentyp

    text

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

    Date Non-Serious Adverse Event Started

    Datentyp

    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)
    Beschreibung

    Non-Serious Adverse Event Start Date immediately post vaccination

    Datentyp

    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
    Beschreibung

    Date Non-Serious Adverse Event Stopped

    Datentyp

    date

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

    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).

    Datentyp

    integer

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

    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.

    Datentyp

    boolean

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

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

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1705586
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    NSAE (unsolicited)

    1 Formulare
    1. StudyEvent: ODM
      1. NSAE (unsolicited)
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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