0 Évaluations
ID

24479

Description

Study ID: 100579 Clinical Study ID: 100579 Study Title: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289757 https://clinicaltrials.gov/ct2/show/NCT00289757 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A Documentation part: Study Conclusion

Lien

https://clinicaltrials.gov/ct2/show/NCT00289757

Mots-clés

Versions (1)
  1. 02/08/2017 02/08/2017 -
Téléchargé le

2 août 2017

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.

    Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Study Conclusion 100579

    Anglais

    Study Conclusion Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100579

    1 Formulaires  
    Follow-up Studies
    Description

    Follow-up Studies

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008976
    UMLS CUI-3
    C0016441
    UMLS CUI-4
    C0170300
    Would the subject be willing to participate in a follow-up study?
    Description

    follow-up study

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0016441
    UMLS CUI [1,2]
    C2348568
    reason for non participation
    Description

    If No, please specify the reason

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0558080
    UMLS CUI [1,2]
    C0679823
    UMLS CUI [1,3]
    C0392360
    Reason for non participation: Adverse Events, or Serious Adverse Events, please specify
    Description

    reason for non participation

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0877248
    UMLS CUI [2,1]
    C0558080
    UMLS CUI [2,2]
    C0679823
    UMLS CUI [2,3]
    C0392360
    Reason for non participation: Other, please specify
    Description

    reason for non participation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0558080
    UMLS CUI [1,2]
    C0679823
    UMLS CUI [1,3]
    C0392360
    Investigator Signature
    Description

    I certify that I have reviewed the data in this case report form, and the Serious Adverse Event section (if applicable) and that all information is complete and accurate.

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2346576
    Long Term Follow-up
    Description

    Long Term Follow-up

    Alias
    UMLS CUI-1
    C1517942
    UMLS CUI-2
    C0170300
    Subject number of previous study
    Description

    Subject number of previous study

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2348585
    UMLS CUI [1,2]
    C2242969
    Date of birth
    Description

    Date of birth

    Type de données

    date

    Alias
    UMLS CUI [1]
    C0421451
    Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
    Description

    long-term follow-up study participation

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C1517942
    UMLS CUI [1,3]
    C0170300
    Subject eligible but not willing to participate due to:
    Description

    long-term follow-up study participation

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C1517942
    UMLS CUI [1,3]
    C0170300
    If adverse events, or serious adverse event, please specify
    Description

    Subject eligible but not willing to participate due to

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0877248
    UMLS CUI [2,1]
    C2348568
    UMLS CUI [2,2]
    C1517942
    UMLS CUI [2,3]
    C0170300
    If Other, please specify
    Description

    Subject eligible but not willing to participate due to

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C1517942
    UMLS CUI [1,3]
    C0170300
    Date of contact
    Description

    Date of contact

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1705415
    Investigator signature
    Description

    Investigator signature

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator signature date
    Description

    Investigator signature date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Retour au début de la page

    Similar models

    Study Conclusion Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100579

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Follow-up Studies
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    C0016441 (UMLS CUI-3)
    C0170300 (UMLS CUI-4)
    follow-up study
    Item
    Would the subject be willing to participate in a follow-up study?
    boolean
    C0016441 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    Item
    reason for non participation
    integer
    C0558080 (UMLS CUI [1,1])
    C0679823 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    reason for non participation
    Code List
    reason for non participation
    CL Item
    Adverse Events, or Serious Adverse Events (1)
    CL Item
    Other (2)
    reason for non participation
    Item
    Reason for non participation: Adverse Events, or Serious Adverse Events, please specify
    text
    C0877248 (UMLS CUI [1])
    C0558080 (UMLS CUI [2,1])
    C0679823 (UMLS CUI [2,2])
    C0392360 (UMLS CUI [2,3])
    reason for non participation
    Item
    Reason for non participation: Other, please specify
    text
    C0558080 (UMLS CUI [1,1])
    C0679823 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Investigator Signature
    Item
    Investigator Signature
    text
    C2346576 (UMLS CUI [1])
    Item Group
    Long Term Follow-up
    C1517942 (UMLS CUI-1)
    C0170300 (UMLS CUI-2)
    Subject number of previous study
    Item
    Subject number of previous study
    text
    C2348585 (UMLS CUI [1,1])
    C2242969 (UMLS CUI [1,2])
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
    integer
    C2348568 (UMLS CUI [1,1])
    C1517942 (UMLS CUI [1,2])
    C0170300 (UMLS CUI [1,3])
    long-term follow-up study participation
    Code List
    Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
    CL Item
    Subject not eligible (1)
    CL Item
    Subject lost to follow-up or not reached  (2)
    CL Item
    Subject eligible but not willing to participate due to: (3)
    CL Item
    Subject eligible and agreed to participate in the long-term follow-up study (4)
    Item
    Subject eligible but not willing to participate due to:
    integer
    C2348568 (UMLS CUI [1,1])
    C1517942 (UMLS CUI [1,2])
    C0170300 (UMLS CUI [1,3])
    undefined item
    Code List
    Subject eligible but not willing to participate due to:
    CL Item
    adverse events, or serious adverse event (1)
    CL Item
    Other (2)
    long-term follow-up study participation
    Item
    If adverse events, or serious adverse event, please specify
    text
    C0877248 (UMLS CUI [1])
    C2348568 (UMLS CUI [2,1])
    C1517942 (UMLS CUI [2,2])
    C0170300 (UMLS CUI [2,3])
    long-term follow-up study participation
    Item
    If Other, please specify
    text
    C2348568 (UMLS CUI [1,1])
    C1517942 (UMLS CUI [1,2])
    C0170300 (UMLS CUI [1,3])
    Date of contact
    Item
    Date of contact
    date
    C0011008 (UMLS CUI [1,1])
    C1705415 (UMLS CUI [1,2])
    Investigator signature
    Item
    Investigator signature
    text
    C2346576 (UMLS CUI [1])
    Investigator signature date
    Item
    Investigator signature date
    date
    C2346576 (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