0 Évaluations
ID

36623

Description

Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

Mots-clés

Versions (1)
  1. 26/05/2019 26/05/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

26 mai 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

    Aucun commentaire

    Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

    DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463

    Anglais

    Visit 4

    1 Formulaires  
    1. StudyEvent: ODM
      1. Visit 4
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Date of visit
    Description

    Date of visit

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject Number
    Description

    Clinical Trial Subject Unique Identifier

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Check for Study Continuation
    Description

    Check for Study Continuation

    Alias
    UMLS CUI-1
    C0805733
    UMLS CUI-2
    C0008976
    Did the subject return for visit 4 ?
    Description

    Continuation status, Clinical Trials

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
    Description

    Continuation status, Clinical Trials, Reason

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0566251
    Specify
    Description

    Continuation status, Clinical Trials, Reason

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0566251
    Please tick who made the decision
    Description

    Continuation status, Clinical Trials, Decision

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0679006
    Laboratory Tests - Blood Sample
    Description

    Laboratory Tests - Blood Sample

    Alias
    UMLS CUI-1
    C0005834
    Has a blood sample been taken ?
    Description

    Collection of blood specimen for laboratory procedure

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    Date (Please complete only if different from visit date)
    Description

    Collection of blood specimen for laboratory procedure, Date in time

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Retour au début de la page

    Similar models

    Visit 4

    1 Formulaires
    1. StudyEvent: ODM
      1. Visit 4
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Check for Study Continuation
    C0805733 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Continuation status, Clinical Trials
    Item
    Did the subject return for visit 4 ?
    boolean
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Item
    If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Continuation status, Clinical Trials, Reason
    Code List
    If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
    CL Item
    Serious adverse event (Please specify SAE No.) (1)
    CL Item
    Non-Serious adverse event (Please specify AE No. or solicited AE code) (2)
    CL Item
    Other, please specify (3)
    Item
    Specify
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Continuation status, Clinical Trials, Reason
    Code List
    Specify
    Item
    Please tick who made the decision
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0679006 (UMLS CUI [1,3])
    Continuation status, Clinical Trials, Reason
    Code List
    Please tick who made the decision
    CL Item
    Investigator  (1)
    CL Item
    Parents/Guardians (2)
    Item Group
    Laboratory Tests - Blood Sample
    C0005834 (UMLS CUI-1)
    Collection of blood specimen for laboratory procedure
    Item
    Has a blood sample been taken ?
    boolean
    C0005834 (UMLS CUI [1])
    Collection of blood specimen for laboratory procedure, Date in time
    Item
    Date (Please complete only if different from visit date)
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Retour au début de la page 

    Aide

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial