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Inhaltsverzeichnis
  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
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- 22.02.19 - 1 Formular, 7 Itemgruppen, 34 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Solicited Adverse Events Record - Local Symptoms, Other Local Symptoms (Day 0 to Day 29), Medication, Solicited Adverse Events Record - General Symptoms, Solicited Adverse Events - Temperature, Other General Symptoms (Day 0 to Day 29)
- 22.02.19 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Elimination Criteria During the Study
- 22.02.19 - 1 Formular, 2 Itemgruppen, 3 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Contraindications to Vaccination
- 22.02.19 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Reason for Non Participation, Serious Adverse Event
- 22.02.19 - 1 Formular, 2 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Demographics
- 22.02.19 - 1 Formular, 2 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Elimination Criteria During the Study
- 20.02.19 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Laboratory Tests
- 20.02.19 - 1 Formular, 7 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Solicited Adverse Events, Solicited Adverse Events Record - Local Symptoms, Solicited Adverse Events - General Symptoms, Solicited Adverse Events Record - General Symptoms, Solicited Adverse Events - Fever, Unsolicited Adverse Events
Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of his form is to document if the subject has had any adverse events in the course of the study. It should be filled out at the date of vaccination. SERIOUS ADVERSE EVENT A serious adverse event is any untoward medical occurrence that: · results in death · is life threatening · results in persistent or significant disability / incapacity · requires in-patient hospitalization · prolongation of existing hospitalization · is a congenital anomaly / birth defect in the offspring of a study subject · In addition, important medical events that may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above should be considered serious. (Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization.) For each serious adverse event the investigator becomes aware of, please fill in a Serious Adverse Event(SAE) report and fax it to GSK Biologicals Study Contact for SAE reporting within 24 hours. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1
- 20.02.19 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Concomitant Vaccination
Study ID: 107495 Clinical Study ID: 107495 Study Title: A phase II, open, randomized study in adults aged between 18 and 60 years designed to evaluate the reactogenicity and immunogenicity of a 1- and 2-dose prime-boost concept of pandemic monovalent (H5N1) influenza vaccine (split virus formulation) adjuvanted with AS03, administered according to different vaccination schedules. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00430521 https://clinicaltrials.gov/ct2/show/NCT00430521 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Pandemic influenza vaccine (GSK1119711A)-formulation 1, Pandemic influenza vaccine (GSK1119711A)-formulation 2 Trade Name: N/A Study Indication: Influenza There are 4 workbooks (WB): WB 1: Protocol 107495, (H5N1-012), Groups: VT/VT/6Mo, VT/IN/6Mo WB 2: Protocol 107495, (H5N1-012), Groups: VT/VT/12Mo, VT/IN/12Mo WB 3: Protocol 107495 (H5N1-012) GROUPS: 2VT/VT/6MO, 2VT/IN/6MO WB 4: Protocol 107495 (H5N1-012) Groups: 2VT/VT/12Mo, 2VT/IN/12Mo Every Workbook has the following visits: Visit Day 0 (Screening, Dose 1), Visit Day 21, Visit Month 6, Visit Month 12 and Visit Month 18. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section, followed by a final study conclusion after Month 18. Workbook 1 schedules a vaccination at screening and Month 6 each, Workbook 2 at Screening and Month 12. 30 days after the first vaccination there is an additional telephone contact. After the second vaccination additional visits/contacts are necessary in both workbooks: a visit at Month 6/12 + 7 and 21 days and a telephone contact on Month 6/12 + 30 days. Workbook 3 schedules a vaccination at screening, Day 21 and Month 6 and Workbook 4 at screening, Day 21 and Month 12. After the second vaccination there is an additional visit on Day 42 and a telephone contact on day 51. After the third vaccination there are additional visits/contacts: visits at Month 6/12 + 7 and 21 days and a telephone contact at Month 6/12 + 30 days. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section. This document contains the Concomitant Vaccination form. It has to be filled in for all Visits/contacts (except screening) for each workbook. Any vaccine not foreseen in the study protocol administered in the period beginning 2 weeks (for inactivated vaccines)or 4 weeks (for live vaccines) preceding each dose of study vaccine and during the following periods: from Day 0 up to Day 51; from 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days is to be recorded with trade name, route of administration and date(s) of administration. Any influenza vaccine other than the candidate vaccines administered during the study period is to be recorded with trade name, route of administration and date(s) of administration.
- 20.02.19 - 1 Formular, 3 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Vaccine administration, Reason for non administration
Study ID: 107495 Clinical Study ID: 107495 Study Title: A phase II, open, randomized study in adults aged between 18 and 60 years designed to evaluate the reactogenicity and immunogenicity of a 1- and 2-dose prime-boost concept of pandemic monovalent (H5N1) influenza vaccine (split virus formulation) adjuvanted with AS03, administered according to different vaccination schedules. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00430521 https://clinicaltrials.gov/ct2/show/NCT00430521 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Pandemic influenza vaccine (GSK1119711A)-formulation 1, Pandemic influenza vaccine (GSK1119711A)-formulation 2 Trade Name: N/A Study Indication: Influenza There are 4 workbooks (WB): WB 1: Protocol 107495, (H5N1-012), Groups: VT/VT/6Mo, VT/IN/6Mo WB 2: Protocol 107495, (H5N1-012), Groups: VT/VT/12Mo, VT/IN/12Mo WB 3: Protocol 107495 (H5N1-012) GROUPS: 2VT/VT/6MO, 2VT/IN/6MO WB 4: Protocol 107495 (H5N1-012) Groups: 2VT/VT/12Mo, 2VT/IN/12Mo Every Workbook has the following visits: Visit Day 0 (Screening, Dose 1), Visit Day 21, Visit Month 6, Visit Month 12 and Visit Month 18. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section, followed by a final study conclusion after Month 18. Workbook 1 schedules a vaccination at screening and Month 6 each, Workbook 2 at Screening and Month 12. 30 days after the first vaccination there is an additional telephone contact. After the second vaccination additional visits/contacts are necessary in both workbooks: a visit at Month 6/12 + 7 and 21 days and a telephone contact on Month 6/12 + 30 days. Workbook 3 schedules a vaccination at screening, Day 21 and Month 6 and Workbook 4 at screening, Day 21 and Month 12. After the second vaccination there is an additional visit on Day 42 and a telephone contact on day 51. After the third vaccination there are additional visits/contacts: visits at Month 6/12 + 7 and 21 days and a telephone contact at Month 6/12 + 30 days. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section. This document contains the Vaccine administration form. It has to be filled in for screening for all workbooks (WB1-4). It also has to be filled in for: WB 1: Visit Month 6 WB 2: Visit Month 12 WB 3: Visit Day 21 and Visit Month 6 WB 4: Visit Day 21 and Visit Month 12
- 13.02.19 - 1 Formular, 6 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Follow-Up Studies, Occurence of SAE, Elimination Criteria, Status of Treatment Blind, Investigators Signature