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Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Concomitant Medication, Non-Serious Adverse Events, Study Conclusion

- 2019-03-11 - 1 Formulär, 14 Item-grupper, 53 Dataelement, 1 Språk
Item-grupper: Administrative data, CONCOMITANT VACCINATION, Vaccination details, CONCOMITANT MEDICATION, Medication details, NON-SERIOUS ADVERSE EVENTS, Adverse Events, STUDY CONCLUSION, PREGNANCY INFORMATION, ELIMINATION CRITERIA, SUBJECT WITHDRAWAL, INVESTIGATOR'S SIGNATURE, USE OF HUMAN SAMPLES BY GSK, INVESTIGATOR'S SIGNATURE
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 3 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

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

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

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