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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 preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B - Visit 4

- 1/5/19 - 1 form, 6 itemgroups, 30 items, 1 language
Itemgroups: Administrative documentation, Vaccination, Before, Evaluation, Laboratory Procedures, Administration of vaccine, Vaccination, Adverse event, Symptoms, Local, Vaccination, Adverse Event, General symptom
Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B - Visit 3

- 1/5/19 - 1 form, 2 itemgroups, 3 items, 1 language
Itemgroups: Administrative documentation, Laboratory Procedures
Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B - Visit 3

- 1/5/19 - 1 form, 2 itemgroups, 3 items, 1 language
Itemgroups: Administrative documentation, Laboratory Procedures
Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B - Eligibility Checklist

- 1/5/19 - 1 form, 4 itemgroups, 26 items, 1 language
Itemgroups: Inclusion, Exclusion Criteria, Enrollment, Exclusion Criteria, During, Clinical Trials, Vaccination, Contraindication
Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B - Concomitant Vaccination

- 1/5/19 - 1 form, 1 itemgroup, 3 items, 1 language
Itemgroup: Vaccination, Concomitant Agent
Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B - Medication

- 1/5/19 - 1 form, 1 itemgroup, 9 items, 1 language
Itemgroup: Pharmaceutical Preparations
Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B - Study Conclusion

- 1/5/19 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Conclusion, Clinical Research, Investigator Signature
Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B - Non-Serious Adverse Events

- 1/4/19 - 1 form, 1 itemgroup, 10 items, 1 language
Itemgroup: Non-Serious Adverse Event
Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B - Informed Consent

- 1/4/19 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Informed Consent, Patient, Informed Consent, Research Personnel
Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B - Informed Consent

- 1/4/19 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Informed Consent, Patient, Informed Consent, Research Personnel
Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065 - Diary Card: Local Symptoms (DTPwHBV Kft + HiberixTM)

- 12/10/18 - 1 form, 9 itemgroups, 57 items, 1 language
Itemgroups: Administrative data, Local Symptoms - Redness (at injection site) DTPw-HBV Kft Vaccine, Local Symptoms - Swelling (at injection site), Local Symptoms - Pain (at injection site), Other Local Symptoms, Local Symptoms - Redness (at injection site) HiberixTM Vaccine, Local Symptoms - Swelling (at injection site) HiberixTM Vaccine, Local Symptoms - Pain (at injection site) HiberixTM Vaccine, Other Local Symptoms
Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065 - Diary Card: Local Symptoms (Plain PRP followed by BTPw-HBV Kft)

- 12/10/18 - 1 form, 5 itemgroups, 24 items, 1 language
Itemgroups: Administrative data, Local Symptoms - Redness (at injection site), Local Symptoms - Swelling (at injection site), Local Symptoms - Pain (at injection site), Other Local Symptoms
Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

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