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35972

Description

Study ID: 107007 Clinical Study ID: 107007 Study Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00344318 https://clinicaltrials.gov/ct2/show/NCT00344318 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal conjugate vaccine GSK1024850A Trade Name: Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin., Poliorix Study Indication: Infections, Streptococcal This study consists of 2 groups of probands (Children of 6-10-14 weeks or 2-4-6 months of age are included): One group receive a 3-dose primary vaccination with the GSK Biologicals' (10-valent) pneumococcal conjugate vaccine. The other group r eceive a 3-dose primary vaccination with Prevenar™. All probands receive DTPw-HBV/Hib and OPV or IPV vaccines. Ths study consists of 3 workbooks (WB): WB 1: The WB 1 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 1; Age for 10 weeks scheduled Visit 3, Timing: Month 2; Age for 14 weeks scheduled Visit 4, Timing: Month 3; Age for +/- 4 months scheduled Intervals between the visits: Visit 1 to Visit 2: 28-42 days, Visit 2 to Visit 3: 28-42 days, Visit 3 to Visit 4: 30-42 days WB 2: The WB 2 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 2; Age for +/- 4 months scheduled Visit 3, Timing: Month 4; Age for +/- 6 months scheduled Visit 4, Timing: Month 5; Age for +/- 7 months scheduled Intervals between the visits: Visit 1 to Visit 2: 49-83 days, Visit 2 to Visit 3: 49-83 days, Visit 3 to Visit 4: 30-42 days WB 3: The WB 3 consists the phone contact (6 months safety follow-up), Timing: Month 8 or 10. This document contains Extended safety follow-up contact form. It has to be filled in for Workbook 3.

Link

https://clinicaltrials.gov/ct2/show/NCT00344318

Keywords

Versions (1)
  1. 4/8/19 4/8/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 8, 2019

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License

Creative Commons BY-NC 3.0
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    Safety, reactogenicity and immunogenicity 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines in infants, NCT00344318

    English

    Extended safety follow-up contact

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Demographics
    Description

    Demographics

    Alias
    UMLS CUI-1
    C0011298
    Center number
    Description

    Center number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Date of Birth
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Description

    Gender

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Study conclusion extended safety follow-up contact
    Description

    Study conclusion extended safety follow-up contact

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008976
    UMLS CUI-3
    C1522577
    Could the subject's parents/guardians be contacted after the end of the active phase?
    Description

    Contact after active phase with parent/legal guardian

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0332158
    UMLS CUI [1,2]
    C0030551
    UMLS CUI [1,3]
    C0332282
    UMLS CUI [1,4]
    C0008976
    UMLS CUI [2,1]
    C0332158
    UMLS CUI [2,2]
    C1274041
    UMLS CUI [2,3]
    C0332282
    UMLS CUI [2,4]
    C0008976
    If contact, note the Date of last contact
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C0805839
    If contact: Has the subject received any other investigational and/or non-registered vaccine and/or drug since the end of the active phase?
    Description

    If you tick yes: GlaxoSmithKline might contact you for further investigation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1517586
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [2,1]
    C0013230
    UMLS CUI [2,2]
    C0205394
    If no contact, give reason
    Description

    Reason for no contact

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1298908
    UMLS CUI [1,2]
    C0332158
    UMLS CUI [1,3]
    C0030551
    UMLS CUI [1,4]
    C0566251
    UMLS CUI [2,1]
    C1298908
    UMLS CUI [2,2]
    C0332158
    UMLS CUI [2,3]
    C1274041
    UMLS CUI [2,4]
    C0566251
    Did the subject experience any serious adverse event(s) (SAE(s) since the end of the active phase?
    Description

    IF you tick yes, please complete the complete Serious Adverse Event (SAE) report

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0008976
    Has the subject experienced any meningitis ?
    Description

    If you tick yes, please complete an SAE form and the meningitis page.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0025289
    Investigator's Signature
    Description

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Description

    I confirm that I have reviewed the Extended Safety Follow-Up data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Printed Investigator's name
    Description

    Printed Investigator's name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date of signature
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Extended safety follow-up contact

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Demographics
    C0011298 (UMLS CUI-1)
    Center number
    Item
    Center number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Date of Birth
    Item
    Date of Birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Male (M)
    CL Item
    Female (F)
    Item Group
    Study conclusion extended safety follow-up contact
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    C1522577 (UMLS CUI-3)
    Item
    Could the subject's parents/guardians be contacted after the end of the active phase?
    text
    C0332158 (UMLS CUI [1,1])
    C0030551 (UMLS CUI [1,2])
    C0332282 (UMLS CUI [1,3])
    C0008976 (UMLS CUI [1,4])
    C0332158 (UMLS CUI [2,1])
    C1274041 (UMLS CUI [2,2])
    C0332282 (UMLS CUI [2,3])
    C0008976 (UMLS CUI [2,4])
    Contact after active phase
    Code List
    Could the subject's parents/guardians be contacted after the end of the active phase?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of last contact
    Item
    If contact, note the Date of last contact
    date
    C0805839 (UMLS CUI [1])
    Item
    If contact: Has the subject received any other investigational and/or non-registered vaccine and/or drug since the end of the active phase?
    text
    C2368628 (UMLS CUI [1,1])
    C1517586 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0013230 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Administration of investigational vaccine
    Code List
    If contact: Has the subject received any other investigational and/or non-registered vaccine and/or drug since the end of the active phase?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    If no contact, give reason
    text
    C1298908 (UMLS CUI [1,1])
    C0332158 (UMLS CUI [1,2])
    C0030551 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    C1298908 (UMLS CUI [2,1])
    C0332158 (UMLS CUI [2,2])
    C1274041 (UMLS CUI [2,3])
    C0566251 (UMLS CUI [2,4])
    Reason for no contact
    Code List
    If no contact, give reason
    CL Item
    Consent withdrawal (CWS)
    CL Item
    Lost to follow-up (LFU)
    Item
    Did the subject experience any serious adverse event(s) (SAE(s) since the end of the active phase?
    text
    C1519255 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    SAE
    Code List
    Did the subject experience any serious adverse event(s) (SAE(s) since the end of the active phase?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    CL Item
    Subject could not be contacted (NA)
    Item
    Has the subject experienced any meningitis ?
    text
    C0025289 (UMLS CUI [1])
    Meningitis after active phase
    Code List
    Has the subject experienced any meningitis ?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    CL Item
    Subject could not be contacted (NA)
    Item Group
    Investigator's Signature
    C2346576 (UMLS CUI-1)
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Printed Investigator's name
    Item
    Printed Investigator's name
    text
    C2826892 (UMLS CUI [1])
    Date of signature
    Item
    Date of signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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