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ID

33185

Description

Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

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Versions (2)
  1. 30/11/2018 30/11/2018 -
  2. 30/11/2018 30/11/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

30 novembre 2018

DOI

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Creative Commons BY-NC 3.0
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    Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021

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    Visit 4: Study Continuation Check

    1 Formulaires  
    Administrative data
    Description

    Administrative data

    Subject Number
    Description

    Subject Number

    Type de données

    integer

    Check for Study Continuation
    Description

    Check for Study Continuation

    Did the subject return for visit 4?
    Description

    Did the subject return for visit 4?

    Type de données

    boolean

    If yes, please complete all forms for Visit 4
    Description

    If yes, please complete all forms for Visit 4

    Type de données

    text

    If No, record ONE most appropriate reason and skip the following pages of this visit
    Description

    If No, record ONE most appropriate reason and skip the following pages of this visit

    Type de données

    text

    If SAE, record the SAE number
    Description

    If SAE, record the SAE number

    Type de données

    integer

    If Non-SAE, record the unsolicited AE number
    Description

    If Non-SAE, record the unsolicited AE number

    Type de données

    integer

    If Other, specify
    Description

    e.g., consent withdrawal, protocol violation, etc.

    Type de données

    text

    Who took the decision?
    Description

    Who took the decision?

    Type de données

    text

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    Visit 4: Study Continuation Check

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    Subject Number
    Item
    Subject Number
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    Item
    Did the subject return for visit 4?
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    If yes, please complete all forms for Visit 4
    Item
    If yes, please complete all forms for Visit 4
    text
    Item
    If No, record ONE most appropriate reason and skip the following pages of this visit
    text
    If No, record ONE most appropriate reason and skip the following pages of this visit
    Code List
    If No, record ONE most appropriate reason and skip the following pages of this visit
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    Serious Adverse Event (1)
    CL Item
    Non-Serious adverse event (2)
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    Other (3)
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    If SAE, record the SAE number
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