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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 10, Year 7) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 29 items, 1 language
Itemgroups: Administrative,Informed Consent,Demographics,Laboratory Tests,Follow-Up Studies,Tracking Document - Reason for non participation,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

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 12, Year 9) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 28 items, 1 language
Itemgroups: Administrative,Informed Consent,Demographics,Laboratory Tests,Follow-Up Studies,Tracking Document - Reason for non participation,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

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 11, Year 8) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 28 items, 1 language
Itemgroups: Administrative,Informed Consent,Demographics,Laboratory Tests,Follow-Up Studies,Tracking Document - Reason for non participation,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

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 9, Year 6) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 9/27/21 - 1 form, 7 itemgroups, 29 items, 1 language
Itemgroups: Administrative,Informed Consent,Demographics,Laboratory Tests,Follow-Up Studies,Tracking Document - Reason for non participation,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

Eligibility Hepatitis B NCT00498212

- 9/27/21 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00498212

Eligibility Hepatitis B NCT00657657

- 9/27/21 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT00657657

Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277) - Annex 2: RAP version of cleaning report defining ELIM code criterion to use

- 9/20/21 - 1 form, 13 itemgroups, 95 items, 1 language
Itemgroups: RAP version of cleaning report defining ELIM code criterion to use,Summary,Serious adverse events,Pregnancies,Elimination from safety and immunology analysis,Elimination from immunology analysis,Extra Elimination from analysis,Other points to consider - Inform Consent procedure not respected,Other points to consider,Replacement Treatment Number,Pending Queries not to be resolved,Others,Signature
Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

Eligibility Hepatitis B, Chronic NCT02097004

- 9/20/21 - 1 form, 2 itemgroups, 31 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02097004

Eligibility Hepatitis B, Chronic NCT01519960

- 9/20/21 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT01519960

Eligibility Hepatitis B, Chronic NCT01521975

- 9/20/21 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
A Two-year Study of Telbivudine in HBeAg Negative Hepatitis; ODM derived from: https://clinicaltrials.gov/show/NCT01521975

Eligibility Hepatitis B NCT02288208

- 9/20/21 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Phase I Safety and Tolerability Study of Birinapant in Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT02288208

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 15) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling

- 9/20/21 - 1 form, 4 itemgroups, 17 items, 1 language
Itemgroups: Administration,Demographics,Laboratory Tests,Serology Conclusion of the Blood Sampling Timepoint Year 14
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

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