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Table des matières
  1. 1. Essai clinique
  2. 2. Routinedokumentation
  3. 3. Études de registres/cohortes
  4. 4. Assurance qualité
  5. 5. Standard de données
  6. 6. Questionnaire pour les patients
  7. 7. Spécialité médicale
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Persönliches Interview SHIP-Trend-1 Impfstatus

- 20/09/2021 - 1 Formulaire, 1 Groupe Item, 18 Eléments de données, 1 Langue
Groupe Item: Impfstatus
Impfstatus form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name TREND.TREND1.INT.INFEKT.INFEKT. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html.
 Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

GSK Study ID 100386 & 100387 Persistence of immune response to TWINRIX™ ADULT Long Term Follow up Year 6 - Long Term Follow up Year 6

- 20/09/2021 - 1 Formulaire, 5 Groupes Item, 26 Eléments de données, 1 Langue
Groupes Item: Long Term Follow up Visit 8, Demographics, Laboratory Tests, Blood sample conclusion, Investigator Signature
Phase III, open, randomized study, in two centres, to demonstrate the equivalence of the 0, 12 month schedule to the 0, 6 month schedule with respect to the immunogenicity and to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined hepatitis A/ hepatitis B vaccine TWINRIX™ ADULT (720 EL. U. of hepatitis A antigen/ 20 μg of recombinant hepatitis B surface antigen) in healthy volunteers aged from 12 to 15 years inclusive. NCT00197171

GSK Study ID 100406/004 Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster, Visit 1 - GSK Study ID 100406/004 Visit 1

- 23/10/2017 - 1 Formulaire, 22 Groupes Item, 235 Eléments de données, 1 Langue
Groupes Item: Informed Consent, Demographics, Eligibility determination, Inclusion criteria, Exclusion Criteria, Medical history, General medical history / physical examination, Pre-vaccination assessment, Laboratory tests, Blood sample, Urine sample (Pregnancy test – HCG), Pre-vaccination assessment, Vaccine adminstration, Reason not administered?, Adverse events - Post - vaccination oberservation, Measurement of mid upper arm circumference, Measurement of mid upper arm circumference, continued, Solicited adverse events - Local symptoms, Local symptoms, Solicited adverse events - General symptoms, General Symptoms, Contact person
A phase III, double-blinded, randomized, multicenter, clinical study to assess the safety and immunogenicity of GSK Biologicals' Tdap 0.3 mg candidate vaccine when given as a booster dose to healthy school children and adolescents (9-13 years of age), previously vaccinated with a 5th consecutive dose of acellular pertussis-containing vaccine, in studies APV-118 or APV-120 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00263679

GSK Study ID 100406/004 Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster Visit 2 - GSK Study ID 100406/004 Visit 2

- 18/10/2017 - 1 Formulaire, 8 Groupes Item, 38 Eléments de données, 1 Langue
Groupes Item: Check for Study Continuation, Pre-vaccination assessment, Laboratory tests, Blood sample, URINE SAMPLE (Pregnancy test – HCG), Vaccine adminstration, Reason not administered?, Adverse events - Post - vaccination oberservation
A phase III, double-blinded, randomized, multicenter, clinical study to assess the safety and immunogenicity of GSK Biologicals' Tdap 0.3 mg candidate vaccine when given as a booster dose to healthy school children and adolescents (9-13 years of age), previously vaccinated with a 5th consecutive dose of acellular pertussis-containing vaccine, in studies APV-118 or APV-120 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00263679

GSK Study ID 100386 & 100387 Persistence of immune response to TWINRIX™ ADULT Long Term Follow up Year 5 - Long Term Follow up Year 5

- 11/10/2017 - 1 Formulaire, 6 Groupes Item, 31 Eléments de données, 1 Langue
Groupes Item: Long Term Follow up Visit 7, Demographics, Laboratory Tests, Follow up Studies, Investigator Signature, Tracking Document
Phase III, open, randomized study, in two centres, to demonstrate the equivalence of the 0, 12 month schedule to the 0, 6 month schedule with respect to the immunogenicity and to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined hepatitis A/ hepatitis B vaccine TWINRIX™ ADULT (720 EL. U. of hepatitis A antigen/ 20 μg of recombinant hepatitis B surface antigen) in healthy volunteers aged from 12 to 15 years inclusive. NCT00197171

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Extended Safety Follow-Up

- 02/04/2019 - 1 Formulaire, 1 Groupe Item, 33 Eléments de données, 1 Langue
Groupe Item: Follow-up
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 15; Study Conclusion) - Follow-Up Studies; Study Conclusion; Tracking Document; Diary Card

- 15/04/2019 - 1 Formulaire, 10 Groupes Item, 64 Eléments de données, 1 Langue
Groupes Item: Administrative, Follow-Up Studies, Study Conclusion, Investigator signature, Tracking Document - Reason for non participation, Diary Card - Local Symptoms (at injection site), Diary Card - Other local symptoms, Diary Card - Medication, Diary 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

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 14; Study Conclusion) - Follow-Up Studies; Study Conclusion; Tracking Document; Diary Card

- 11/04/2019 - 1 Formulaire, 10 Groupes Item, 64 Eléments de données, 1 Langue
Groupes Item: Administrative, Follow-Up Studies, Study Conclusion, Investigator signature, Tracking Document - Reason for non participation, Diary Card - Local Symptoms (at injection site), Diary Card - Other local symptoms, Diary Card - Medication, Diary 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

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 13; Study Conclusion) - Follow-Up Studies; Study Conclusion; Tracking Document; Diary Card

- 11/04/2019 - 1 Formulaire, 10 Groupes Item, 64 Eléments de données, 1 Langue
Groupes Item: Administrative, Follow-Up Studies, Investigator signature, Study Conclusion, Tracking Document - Reason for non participation, Diary Card - Local Symptoms, Diary Card - Other local symptoms, Diary Card - Medication, Diary 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) - Study Conclusion - Follow-Up Studies; Study Conclusion; Tracking Document; Diary Card

- 10/04/2019 - 1 Formulaire, 10 Groupes Item, 63 Eléments de données, 1 Langue
Groupes Item: Administrative, Follow-Up Studies, Investigator signature, Study Conclusion, Tracking Document - Reason for non participation, Diary Card - Local Symptoms, Diary Card - Other local symptoms, Diary Card - Medication, Diary Card - General Symptoms, Diary Card - Other general Symptoms
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

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 11) - Follow-Up Studies; Study Conclusion

- 08/04/2019 - 1 Formulaire, 4 Groupes Item, 20 Eléments de données, 1 Langue
Groupes Item: Administrative, Follow-Up Studies, Study Conclusion, Investigator signature
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) - Study Conclusion - Follow-Up Studies; Study Conclusion; Tracking Document; Diary Card

- 06/04/2019 - 1 Formulaire, 10 Groupes Item, 63 Eléments de données, 1 Langue
Groupes Item: Administrative, Follow-Up Studies, Investigator signature, Study Conclusion, Tracking Document - Reason for non participation, Diary Card - Local Symptoms, Diary Card - Other local symptoms, Diary Card - Medication, Diary Card - General Symptoms, Diary Card - Other general Symptoms
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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