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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056 - Miscellaneous Forms: Temperature Log, Adverse Events, Rash, Gland Swelling, Febrile Convulsions, Concomitant Medication

- 2019-10-30 - 1 Formulär, 13 Item-grupper, 73 Dataelement, 1 Språk
Item-grupper: Administrative data, Temperature Log, Reminder, Rash / Exanthem, Rash Event Log, Parotid/Salivary Gland Swelling Events, Febrile Convulsions - Suspected Signs of Meningitis, Concomitant Vaccination, Concomitant Vaccination Details, Concomitant Medications, Concomitant Medications Details, Non-Serious Adverse Events, Non-Serious Adverse Events Log
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

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Rash / Exanthema

- 2019-04-02 - 1 Formulär, 2 Item-grupper, 14 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Exanthema
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056 - Diary Card - Booster Dose (day 0-day 42)

- 2019-01-10 - 1 Formulär, 10 Item-grupper, 32 Dataelement, 1 Språk
Item-grupper: Administrative data, Temperature, Temperature Log, Rash / Exanthem, Rash Event Log, Parotid / Salivary Gland Swelling, Parotid/Salivary Gland Swelling Events, Febrile Convulsions - Suspected Signs of Meningism, Febrile Convulsions Log, Reminder
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

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

- 2018-12-25 - 1 Formulär, 3 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: 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”

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

- 2018-11-27 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: 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

- 2018-11-27 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: 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)

- 2018-11-26 - 1 Formulär, 7 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: 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)

- 2018-11-26 - 1 Formulär, 7 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: 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

- 2018-11-26 - 1 Formulär, 3 Item-grupper, 15 Dataelement, 1 Språk
Item-grupper: 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

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