Keywords
Hepatitis B Vaccines ×
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Table of contents
  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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- 8/28/19 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: Administrative documentation, Vaccination history, Vaccination details
Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains information on the subject's previous BCG and HBV vaccinations, as well as other previous vaccinations, and is to be filled in at Visit 1.
- 6/1/19 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Immunosenescence and Hepatitis B Virus (HBV) Vaccine Efficacy in Chronic Renal Disease Patient; ODM derived from: https://clinicaltrials.gov/show/NCT02375711 Brief Summary: The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency. Detailed Description: The risk of infection with hepatitis B during exposure to blood is high (30% against 1.8% for Hepatitis C Virus and HIV 1%) and dialysis patients are a population at risk. Vaccination against this virus, which is very effective in the general population (vaccine response: 90 to 95%), is highly recommended in dialysis patients. However, numerous studies have shown that HBV vaccination was less effective in patients with chronic renal disease than in the general population. The reasons for low vaccine response are poorly understood. However, recent data suggest that renal failure could induce accelerated immunosenescence. The aging of the immune system, or immunosenescence, is a complex and profound phenomenon of the immune system during life. The gradual reduction of the generation of naive T cells in the thymus is the major cause of immunosenescence. But this process is also associated with an accumulation of lymphocytes at the end of differentiation. In this context, the decrease in vaccine response and increased infections in renal insufficiency might be correlated, as in the elderly population, with the aging of the immune system. The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency. Vaccination against HBV is not performed for the purposes of the study, but due to the existing vaccine indication for the subject. Included patients receive vaccination as routine care according to the recommendations and the vaccination schedule recommended by the Health Authority.
- 2/28/19 - 1 form, 12 itemgroups, 48 items, 1 language
Itemgroups: Administrative data, CHECK FOR STUDY CONTINUATION, LABORATORY TESTS (GROUPS DTPW-HBV Kft + Hiberix™), LABORATORY TESTS (OTHERS GROUPS), CONCOMITANT VACCINATION, MEDICATION, NON-SERIOUS ADVERSE EVENTS, STUDY CONCLUSION, OCCURRENCE OF SERIOUS ADVERSE EVENT, ELIMINATION CRITERIA, WITHDRAWAL FROM STUDY, INVESTIGATOR'S SIGNATURE
- 2/28/19 - 1 form, 14 itemgroups, 166 items, 1 language
Itemgroups: Administrative data, CHECK FOR STUDY CONTINUATION, VACCINE ADMINISTRATION, VACCINE ADMINISTRATION 2, VACCINE ADMINISTRATION 3, VACCINE NON-ADMINISTRATION, ADVERSE EVENTS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, LOCAL SYMPTOMS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific), DTPw-HBV Kft. vaccine, Hiberix™ vaccine, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, GENERAL SYMPTOMS
- 2/28/19 - 1 form, 14 itemgroups, 166 items, 1 language
Itemgroups: Administrative data, CHECK FOR STUDY CONTINUATION, VACCINE ADMINISTRATION, VACCINE ADMINISTRATION 2, VACCINE ADMINISTRATION 3, VACCINE NON-ADMINISTRATION, ADVERSE EVENTS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, LOCAL SYMPTOMS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific), DTPw-HBV Kft. vaccine, Hiberix™ vaccine, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, GENERAL SYMPTOMS
- 2/28/19 - 1 form, 17 itemgroups, 203 items, 1 language
Itemgroups: Administrative data, CHECK FOR STUDY CONTINUATION, GENERAL MEDICAL HISTORY, PHYSICAL EXAMINATION, LABORATORY TESTS, VACCINE ADMINISTRATION, VACCINE ADMINISTRATION 2, VACCINE ADMINISTRATION 3, VACCINE NON-ADMINISTRATION, ADVERSE EVENTS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, LOCAL SYMPTOMS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific), DTPw-HBV Kft. vaccine, Hiberix™ vaccine, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, GENERAL SYMPTOMS
- 2/28/19 - 1 form, 12 itemgroups, 48 items, 1 language
Itemgroups: Administrative data, CHECK FOR STUDY CONTINUATION, LABORATORY TESTS (GROUPS DTPW-HBV Kft + Hiberix™), LABORATORY TESTS (OTHERS GROUPS), Concomitant Vaccination, MEDICATION, NON-SERIOUS ADVERSE EVENTS, STUDY CONCLUSION, OCCURRENCE OF SERIOUS ADVERSE EVENT, ELIMINATION CRITERIA, WITHDRAWAL FROM STUDY, INVESTIGATOR'S SIGNATURE
- 2/28/19 - 1 form, 10 itemgroups, 51 items, 1 language
Itemgroups: ELIMINATION CRITERIA DURING THE STUDY, CONTRAINDICATIONS TO SUBSEQUENT VACCINATION, PRECAUTIONS, INFORMED CONSENT, DEMOGRAPHICS, ELIGIBILITY CHECK, INCLUSION CRITERIA, EXCLUSION CRITERIA, RANDOMISATION / TREATMENT ALLOCATION, GROUP HBV AT BIRTH
- 2/28/19 - 1 form, 17 itemgroups, 199 items, 1 language
Itemgroups: Administrative data, CHECK FOR STUDY CONTINUATION, GENERAL MEDICAL HISTORY, PHYSICAL EXAMINATION, LABORATORY TESTS, VACCINE ADMINISTRATION, VACCINE ADMINISTRATION 2, VACCINE ADMINISTRATION 3, VACCINE NON-ADMINISTRATION, ADVERSE EVENTS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, LOCAL SYMPTOMS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific), DTPw-HBV Kft. vaccine, Hiberix™ vaccine, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, GENERAL SYMPTOMS
- 2/28/19 - 1 form, 17 itemgroups, 199 items, 1 language
Itemgroups: Administrative data, CHECK FOR STUDY CONTINUATION, GENERAL MEDICAL HISTORY, PHYSICAL EXAMINATION, LABORATORY TESTS, VACCINE ADMINISTRATION, VACCINE ADMINISTRATION 2, VACCINE ADMINISTRATION 3, VACCINE NON-ADMINISTRATION, ADVERSE EVENTS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, LOCAL SYMPTOMS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific), DTPw-HBV Kft. vaccine, Hiberix™ vaccine, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, GENERAL SYMPTOMS
- 2/28/19 - 1 form, 17 itemgroups, 199 items, 1 language
Itemgroups: Administrative data, CHECK FOR STUDY CONTINUATION, GENERAL MEDICAL HISTORY, PHYSICAL EXAMINATION, LABORATORY TESTS, VACCINE ADMINISTRATION, VACCINE ADMINISTRATION 2, VACCINE ADMINISTRATION 3, VACCINE NON-ADMINISTRATION, ADVERSE EVENTS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, LOCAL SYMPTOMS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific), DTPw-HBV Kft. vaccine, Hiberix™ vaccine, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, GENERAL SYMPTOMS