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Geselecteerde datamodellen

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20 Zoekresultaten.
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Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020 - Diary Card: Rash/Exanthem + Parotid/Salivary gland swelling + Febrile Convulsions - Dose 2

- 27-11-18 - 1 Formulier, 2 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Rash Episode
Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella

Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020 - Diary Card: Rash/Exanthem + Parotid/Salivary gland swelling + Febrile Convulsions

- 27-11-18 - 1 Formulier, 2 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Rash Episode
Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella

Immunogenicity of Combined Measles Mumps Rubella Varicella Vaccine for healthy 2 y.o children - 104020 - Visit 2: Solicited Adverse Events - General Symptoms (All Groups)

- 26-11-18 - 1 Formulier, 7 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Administrative data, General Symptoms, General Symptom 1, Symptom 2, Symptom 3, Symptom 4, Please report serious adverse events to GSK by telephone within 24 hours
Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella CRF Seiten: 268-336; 870-938

Immunogenicity of Combined Measles Mumps Rubella Varicella Vaccine for healthy 2 y.o children - 104020 - Visit 1: Solicited Adverse Events - General Symptoms (All Groups)

- 26-11-18 - 1 Formulier, 7 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Administrative data, General Symptoms, General Symptom 1, Symptom 2, Symptom 3, Symptom 4, Please report serious adverse events to GSK by telephone within 24 hours
Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella CRF Seiten: 268-336; 870-938

Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020 - Rash / Exanthem AE Form

- 26-11-18 - 1 Formulier, 3 Itemgroepen, 15 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Rash/Exanthem, Further Event Details (For GSK)
Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella CRF Seiten: 268-336; 870-938

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Record of Rash

- 25-12-18 - 1 Formulier, 3 Itemgroepen, 9 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Record of Rash, Conclusion
Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any recorded rash during the study. It should be filled out everytime a rash occurs during study. A blood sample for PK analysis is to be obtained. Enter details on the “Protocol Deviation Log”

IDMC Consensus Report - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 03-09-17 - 1 Formulier, 8 Itemgroepen, 25 Data-elementen, 1 Taal
Itemgroepen: Rash, Fever, Systemic signs, Subjective assessment of the illness by investigator, Varicella Clinical Case?, PCR result, Classification varicella, Expert signature
IDMC Consensus Report - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Diary Card - Varicella /Zoster Case - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 28-08-17 - 1 Formulier, 10 Itemgroepen, 40 Data-elementen, 1 Taal
Itemgroepen: Rash, Lesion, Vesicles, Temperature, Temperature, Weekdays location, Varicella or zoster index case, End Date Varicella or zoster, Health economics, Pain
Diary Card - Varicella /Zoster Case - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 2

- 27-08-17 - 1 Formulier, 9 Itemgroepen, 50 Data-elementen, 1 Taal
Itemgroepen: Solicited Symptoms, Temperature, Temperature, Temperature, Rash / exanthema, Parotid / Salivary gland swelling events, Convulsion, Unsolicited symptoms (day 0 - day 42), Medication (day 0 - day 42)
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 2 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 1

- 27-08-17 - 1 Formulier, 9 Itemgroepen, 50 Data-elementen, 1 Taal
Itemgroepen: Solicited Symptoms, Temperature, Temperature, Temperature, Rash / exanthema, Parotid / Salivary gland swelling events, Convulsion, Unsolicited symptoms (day 0 - day 42), Medication (day 0 - day 42)
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 1 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card Dose 2

- 26-08-17 - 1 Formulier, 8 Itemgroepen, 50 Data-elementen, 1 Taal
Itemgroepen: Solicited Symptoms, Unsolicited symptoms (day 0 - day 42), Temperature, Temperature, Temperature, Rash / exanthema, Parotid / Salivary gland swelling events, Febrile convulsions - Suspected signs of meningism events
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card Dose 2 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card Dose 1

- 26-08-17 - 1 Formulier, 8 Itemgroepen, 50 Data-elementen, 1 Taal
Itemgroepen: Solicited Symptoms, Unsolicited symptoms (day 0 - day 42), Temperature, Temperature, Temperature, Rash / exanthema, Parotid / Salivary gland swelling events, Febrile convulsions - Suspected signs of meningism events
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card Dose 1 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

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