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Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 12, Visit 1) - Informed Consent; Demographics; General medical history/ Physical examination; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

- 2021-09-20 - 1 Formulär, 12 Item-grupper, 101 Dataelement, 1 Språk
Item-grupper: Administration, Demographics, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, HCG Urine Pregnancy Test, Blood Sample Conclusion, Vaccine Administration, Vaccine Administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - 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

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532) - Screening - Consent Demographics; Central Laboratory; Dermatological Neurological Exam; ECG

- 2020-01-09 - 1 Formulär, 9 Item-grupper, 63 Dataelement, 1 Språk
Item-grupper: Administrative, Informed Consent, Demography, Central Laboratory - Electronically Transferred Lab Data, Central Laboratory - Possible Liver Events, Dermatological Exam, Neurological Exam, Neurological Exam , 12 Lead Electrocardiogram
Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Visit "Day 0" Vaccination

- 2019-03-11 - 1 Formulär, 29 Item-grupper, 196 Dataelement, 1 Språk
Item-grupper: Administrative data, ELIMINATION CRITERIA, INFORMED CONSENT, DEMOGRAPHICS, ELIGIBILITY CHECK, INCLUSION CRITERIA, EXCLUSION CRITERIA, TREATMENT ALLOCATION, GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION, HISTORY OF INFLUENZA VACCINATION, LABORATORY TESTS, HCG URINE PREGNANCY TEST, VACCINE ADMINISTRATION, VACCINE NON-ADMINISTRATION, SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Induration, Local Symptoms - Ecchymosis, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, General Symptoms - Temperature, General Symptoms - Fatigue, General Symptoms - Headache, General Symptoms - Myalgia, General Symptoms - Shivering, General Symptoms - Arthralgia, General Symptoms - Sweating increase, UNSOLICITED ADVERSE EVENTS
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Screening Visit

- 2019-03-06 - 1 Formulär, 17 Item-grupper, 137 Dataelement, 1 Språk
Item-grupper: ELIMINATION CRITERIA DURING THE STUDY, CONTRAINDICATIONS TO SUBSEQUENT VACCINATION, INFORMED CONSENT, DEMOGRAPHICS, ELIGIBILITY CHECK, INCLUSION CRITERIA, EXCLUSION CRITERIA, GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION, VITAL SIGNS, HEMATOLOGY / BIOCHEMISTRY, HEMATOLOGY, BIOCHEMISTRY, LDH, URINALYSIS, Urinalysis (Dipstick) Test, SCREENING CONCLUSION, INVESTIGATOR'S SIGNATURE
Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974 - Visit 1: Eligibility Criteria, Consent Form

- 2019-01-09 - 1 Formulär, 23 Item-grupper, 137 Dataelement, 1 Språk
Item-grupper: Administrative data, Elimination Criteria During The Study, Contraindications To Subsequent Vaccination, Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines, Precautions for Vaccination, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, Randomisation / Treatment Allocation, Physical Examination, Vaccine History, Laboratory Tests - Blood, Vaccine Administration, Vaccine, Vaccine 2, Non-administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - Local Symptoms - Vaccine 2, Solicited Adverse Events, General Symptoms
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B - Visit 1

- 2019-01-05 - 1 Formulär, 10 Item-grupper, 45 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Informed Consent, Demographics Domain, Eligibility Determination, Medical History, Physical Examination, 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

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