ID
35691
Descripción
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
Palabras clave
Versiones (1)
- 15/3/19 15/3/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
15 de marzo de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)
Visit 2, 3 and 5 - Laboratory Tests
- StudyEvent: ODM
Descripción
Laboratory Tests - Visit 2
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0545082
Descripción
Laboratory Tests - Visit 3
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0545082
Descripción
Laboratory Tests - Visit 5
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0545082
Descripción
Subjects who fail to exhibit a satisfactory immune response following the two-dose candidate vaccine course, as evidenced by anti-HBs titre ≥ 10mIU/ml and/or seropositivity for anti-HAV, will be p rovided an additional dose of the appropriate commercial vaccine.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005834
Similar models
Visit 2, 3 and 5 - Laboratory Tests
- StudyEvent: ODM
C0545082 (UMLS CUI-2)
C0545082 (UMLS CUI-2)
C0545082 (UMLS CUI-2)