ID
35700
Beskrivning
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline 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
Nyckelord
Versioner (1)
- 2019-03-16 2019-03-16 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
16 mars 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)
Informed Consent for the long-term follow-up
- StudyEvent: ODM
Beskrivning
Administrative
Alias
- UMLS CUI-1
- C1320722
Beskrivning
Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion:
Alias
- UMLS CUI-1
- C1710187
- UMLS CUI-2
- C0031831
- UMLS CUI-3
- C0028661
- UMLS CUI-4
- C1709701
- UMLS CUI-5
- C0401893
- UMLS CUI-6
- C0021430
Beskrivning
I have carefully explained the nature, demands and foreseeable risks and benefits of the vaccination study to the person named above and witnessed the completion of the written consent form.
Datatyp
text
Alias
- UMLS CUI [1]
- C0027365
Beskrivning
Signature
Datatyp
text
Alias
- UMLS CUI [1]
- C1519316
Beskrivning
Designation
Datatyp
text
Alias
- UMLS CUI [1]
- C0442504
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Time
Datatyp
time
Alias
- UMLS CUI [1]
- C0040223
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Informed Consent for the long-term follow-up
- StudyEvent: ODM
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