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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
  7. 7. Medical Specialty
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289 Search results.

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

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 12, Visit 1) - Informed Consent; Demographics; General medical history/ Physical examination; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

- 9/20/21 - 1 form, 12 itemgroups, 101 items, 1 language
Itemgroups: Administration, Demographics, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, HCG Urine Pregnancy Test, Blood Sample Conclusion, Vaccine Administration, Vaccine Administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - 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

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 14) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling

- 9/20/21 - 1 form, 5 itemgroups, 19 items, 1 language
Itemgroups: Administration, Demographics, Serious Adverse Events, Laboratory Tests, Serology Conclusion of the Blood Sampling Timepoint Year 13
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

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 13) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling

- 9/20/21 - 1 form, 5 itemgroups, 17 items, 1 language
Itemgroups: Administration, Demographics, Serious Adverse Events, Laboratory Tests, Serology Conclusion of the Blood Sampling Timepoint Year 12
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

Eligibility Hepatitis B NCT02203357

- 9/20/21 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Randomized,Paralleled-group Clinical Trial of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Adults; ODM derived from: https://clinicaltrials.gov/show/NCT02203357

Eligibility Hepatitis B NCT02032160

- 9/20/21 - 1 form, 2 itemgroups, 20 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study to Characterise Immune Responses Following Immunisations With "Fendrix" or "Engerix B" Hepatitis B Vaccines; ODM derived from: https://clinicaltrials.gov/show/NCT02032160

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 13, Year 10) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion Before Booster

- 9/20/21 - 1 form, 5 itemgroups, 14 items, 1 language
Itemgroups: Administrative, Informed Consent, Demographics, Laboratory Tests, Serology Conclusion Before Booster
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