ID
23149
Beschreibung
Study ID: 100551 (EXT Y11) Clinical Study ID: 100551 Study Title: A double blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B vaccine when administered in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289770 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Stichworte
Versionen (3)
- 26.06.17 26.06.17 -
- 26.09.17 26.09.17 -
- 20.09.21 20.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
26. Juni 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 17 Year 11)
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 17 Year 11)
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General Information
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Demographics
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Center number
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integer
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Date of birth
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date
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Gender
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Race
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Specification of other race
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Laboratory tests
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Blood sample
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text
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Date of blood sample (if different from visit date)
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date
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Hepatitis A or Hepatitis B vaccine
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text
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Specification of received Hepatitis A or Hepatitis B vaccine
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Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding
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Specification of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding
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Study Conclusion
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Follow-up studies
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Specification of the most appropriate reason the subject is not willing to participate in a follow-up study
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Specification of Adverse Events or Serious Adverse Events
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Specification of other reason for not willing to participate in a follow-up study
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Serious Adverse Event
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Investigator´s signature
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I confirm that I have reviewed the 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
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Date
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date
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Printed investigator´s name
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Tracking Document - Reason for non participation
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Previous Subject Number
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integer
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Date of Birth
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date
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Reason for non participation
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Alias
- UMLS CUI [1]
- C3166257
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Eligibility
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Specification of adverse event or serious adverse event
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Specification of other reason for non participation
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text