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Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020 - Diary Card: Unsolicited Symptoms (All Groups)

- 27.11.18 - 1 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Other Symptoms (Day 0-42), Medication
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 - Concomitant Medication Form

- 26.11.18 - 1 Formular, 3 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Concomitant Medication, List of Medications
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 - Febrile Convulsions AE Form

- 26.11.18 - 1 Formular, 3 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Febrile Convulsions - Suspected Signs of Meningitis, Further 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

Immunogenicity of Combined Measles Mumps Rubella Varicella Vaccine for healthy 2 y.o children - 104020 - Solicited Adverse Events (Group Priorix+Varilrix)

- 26.11.18 - 1 Formular, 8 Itemgruppen, 46 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Local Symptoms, Priorix Vaccine - Local Symptoms, Priorix Vaccine - Local Symptoms, Priorix Vaccine - Local Symptoms, Varilrix Vaccine - Local Symptoms, Varilrix Vaccine - Local Symptoms, Varilrix Vaccine - Local Symptoms
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 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: 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

Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020 - Elimination Criteria

- 22.11.18 - 1 Formular, 2 Itemgruppen, 2 Datenelemente, 1 Sprache
Itemgruppen: Note, Elimination Criteria
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

Eligibility Measles NCT00313950

- 14.05.17 - 1 Formular, 2 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT00313950

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