ID
35700
Beschreibung
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
Stichworte
Versionen (1)
- 16.03.19 16.03.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
16. März 2019
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
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
Beschreibung
Administrative
Alias
- UMLS CUI-1
- C1320722
Beschreibung
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
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C0027365
Beschreibung
Signature
Datentyp
text
Alias
- UMLS CUI [1]
- C1519316
Beschreibung
Designation
Datentyp
text
Alias
- UMLS CUI [1]
- C0442504
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Time
Datentyp
time
Alias
- UMLS CUI [1]
- C0040223
Ähnliche Modelle
Informed Consent for the long-term follow-up
- StudyEvent: ODM
C1517942 (UMLS CUI-2)
C0030551 (UMLS CUI [1,2])
C1301584 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C1443235 (UMLS CUI [3,1])
C0085537 (UMLS CUI [3,2])
C1301584 (UMLS CUI [4,1])
C0085537 (UMLS CUI [4,2])
C1443235 (UMLS CUI [1,2])
C0679646 (UMLS CUI [2,1])
C1301584 (UMLS CUI [2,2])
C1519316 (UMLS CUI [1,2])
C1443235 (UMLS CUI [1,2])
C0030551 (UMLS CUI [2,1])
C1301584 (UMLS CUI [2,2])
C0023226 (UMLS CUI [3,1])
C1443235 (UMLS CUI [3,2])
C0023226 (UMLS CUI [4,1])
C1301584 (UMLS CUI [4,2])
C1519316 (UMLS CUI [1,2])
C0023226 (UMLS CUI [2,1])
C1519316 (UMLS CUI [2,2])
C0679646 (UMLS CUI [1,2])
C1515258 (UMLS CUI [1,2])
C0031831 (UMLS CUI-2)
C0028661 (UMLS CUI-3)
C1709701 (UMLS CUI-4)
C0401893 (UMLS CUI-5)
C0021430 (UMLS CUI-6)