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Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Concomitant Vaccination; Medication; Non-Serious Adverse Events; Study Conclusion; Tracking Document; Diary Card

- 11/04/19 - 1 modulo, 15 itemgroups, 107 elementi, 1 linguaggio
Itemgroups: Administrative, Concomitant Vaccination, Concomitant Vaccination, Medication, Medication, Non-Serious Adverse Events, Non-Serious Adverse Events, Study Conclusion, Investigator's signature, Tracking Document - Reason for non participation, Diary Card - Local Symptoms (at injection site), Diary Card - Other local symptoms, Diary Card - Medication, Diaray Card - General Symptoms, Diary Card - Other general Symptoms
Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 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

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Month 60) - Demographics; Laboratory Tests; Follow-Up Studies; Safety Follow-Up - Serious Adverse Events; Tracking Document

- 18/03/19 - 1 modulo, 15 itemgroups, 76 elementi, 1 linguaggio
Itemgroups: Administrative, Demographics, Laboratory Tests, Follow-Up Studies, Investigator Signature, Serious Adverse Events, SAE - Study Vaccine Information (13), SAE - Concomitant medication / vaccination that could have contributed to this SAE (14), SAE - Relevant intercurrent illness & medical history that could have contributed to this SAE (15), Drug(s) used to treat this SAE (16), Surgical treatment for this SAE (17), Description (18), SAE - Comments, Tracking Document, Investigator signature
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

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