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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
    1. 7.1. Anesthesiology
    1. 7.2. Dermatology
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    1. 7.6. Internal Medicine
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      1. Infectious Diseases
      1. Cardiology/Angiology
      1. Pneumology
      1. Gastroenterology
      1. Nephrology
      1. Endocrinology/Metabolic Diseases
      1. Rheumatology
    1. 7.7. Neurology
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    1. 7.9. Palliative Care
    1. 7.10. Pathology/Forensics
    1. 7.11. Pediatrics
    1. 7.12. Psychiatry/Psychosomatics
    1. 7.13. Radiology
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021 - Demographics, Randomisation, Weight, and HBV Immunization Status

- 8/24/21 - 1 form, 5 itemgroups, 10 items, 1 language
Itemgroups: Administrative, Demographics, Randomisation / Treatment allocation, Body weight, HBV immunization status
Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/NCT00307021. A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum malaria vaccine RTS,S/AS01E (0.5 mL dose) to RTS,S/AS02D (0.5 mL dose) administered IM according to a 0, 1, 2- month vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. Randomisation / Treatment Allocation takes place at visit 2 prior to the first vaccination. The subsequent record treatment number should documented at visit 2. Information on the subject's demographics, body weight, and HBV immunization status (incl. vaccination dates) should also be recorded at clinical visit 2. Please note that informed consent has to be obtained prior to any study procedure.

Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Study Conclusion NCT00317161 - Study Conclusion Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

- 6/29/17 - 1 form, 1 itemgroup, 15 items, 1 language
Itemgroup: Study Conclusion
Study ID: 100480 Clinical Study ID: 100480 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Visit 2: Study Conclusion

Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Visit 2 NCT00317161 - Visit 2 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

- 6/29/17 - 1 form, 7 itemgroups, 64 items, 1 language
Itemgroups: Check for Study Continuation, Laboratory Tests, Protocol required Concomitant Vaccination, Large Swelling Reaction, Concomitant Vaccination, Medication, Non-serious Adverse Events
Study ID: 100480 Clinical Study ID: 100480 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Visit 2: 30 – 42 days after Visit 1

Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Visit 1 NCT00317161 - Visit 1 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

- 6/21/17 - 1 form, 14 itemgroups, 233 items, 1 language
Itemgroups: Informed Consent, Demographics, Eligibility Question, Randomisation, General Medical History / Physical Examination, Laboratory Tests, Protocol required Concomitant Vaccination, Vaccine Administration, Single Injection, Vaccine Administration, Multi Injections, Solicited Adverse Events - Local Symptoms - Booster Dose, Solicited Adverse Events - Local Symptoms - DTPw-HBV/Hib vaccine, Solicited Adverse Events - Local Symptoms - Meningitec vaccine, Solicited Adverse Events - General Symptoms, Unsolicited Adverse Events
Study ID: 100480 Clinical Study ID: 100480 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Visit 1: 15-24 months of age

Visit 6 Booster Dose Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 10/15/17 - 1 form, 8 itemgroups, 35 items, 1 language
Itemgroups: Header, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Other General Symptoms
Visit 6 Booster Dose Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A 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

Visit 6 Booster Dose Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 10/15/17 - 1 form, 8 itemgroups, 35 items, 1 language
Itemgroups: Header, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Other General Symptoms
Visit 6 Booster Dose Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A 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

Visit 4 Dose 2 Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 10/15/17 - 1 form, 8 itemgroups, 35 items, 1 language
Itemgroups: Header, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Other General Symptoms
Visit 4 Dose 2 Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A 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

Visit 3 Dose 1 Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 8/29/17 - 1 form, 8 itemgroups, 35 items, 1 language
Itemgroups: Header, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Other General Symptoms
Visit 3 Dose 1 Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A 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

Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Study Conclusion NCT00317161 - Study Conclusion Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

- 6/29/17 - 1 form, 1 itemgroup, 15 items, 1 language
Itemgroup: Study Conclusion
Study ID: 104730 Clinical Study ID: 104730 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Visit 2: Study Conclusion

Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Visit 4 NCT00317161 - Visit 4 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

- 6/29/17 - 1 form, 6 itemgroups, 39 items, 1 language
Itemgroups: Check for Study Continuation, Laboratory Tests, Protocol incentives Concomitant Vaccination, Concomitant Vaccination, Medication, Non-serious Adverse Events
Study ID: 100480 Clinical Study ID: 100480 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Visit 4: 30 – 42 days after visit 3

Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Visit 3 NCT00317161 - Visit 3 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

- 6/29/17 - 1 form, 8 itemgroups, 147 items, 1 language
Itemgroups: Demographics, Eligibility Question, General Medical History / Physical Examination, Laboratory Tests, Vaccine Administration, Solicited Adverse Events - Local Symptoms - Booster Dose, Solicited Adverse Events - General Symptoms, Unsolicited Adverse Events
Study ID: 100480 Clinical Study ID: 100480 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Visit 3: 24 – 30 months of age and at least 6 months (183 days) after Visit 1

Visit 6 Booster Dose General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 8/25/17 - 1 form, 11 itemgroups, 63 items, 1 language
Itemgroups: Header, SOLICITED ADVERSE EXPERIENCES - GENERAL SYMPTOMS, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Seriousness of symptoms, V. OTHER GENERAL SYMPTOMS, Administrative Data
Visit 6 Booster Dose General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A 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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