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Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 23 Year 15)

- 2017-09-26 - 1 Formulär, 13 Item-grupper, 61 Dataelement, 1 Språk
Item-grupper: General Information, Laboratory tests, Concomitant Vaccination, Specification of concomitant Vaccination, Additional Vaccination / Medication, Specification of additional Vaccination / Medication, Non-Serious Adverse Events, Non-Serious Adverse Events, Follow-up studies, Study Conclusion, Investigator´s signature, Tracking Document, Final information
Study ID: 100551 (EXT Y11) Clinical Study ID: 100551 Study Title: A double blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B vaccine when administered in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289770 Sponsor: GlaxoSmithKline Collaborators: N/A 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

GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines Study ID: 101695 NCT00343915 - Visit 4, Month 6, 180 + 21 Days after Visit 1, Dose 3

- 2018-03-20 - 1 Formulär, 12 Item-grupper, 56 Dataelement, 1 Språk
Item-grupper: Administration, Pre-vaccination assessment, Vaccine administration, Solicited adverse events - Local Symptoms, Redness, Swelling, Pain, Solicited adverse events - General symptoms, Fever, Fatigue, Headache, Gastrointestinal symptoms
Visit 4 Study ID: 101695 Ext. Mth30 Clinical Study ID: 101695 Study Title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00343915 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines Study ID: 101695 NCT00343915 - Visit 2, Month 1, 30 + 10 days after Visit 1, Dose 2

- 2018-03-20 - 1 Formulär, 12 Item-grupper, 56 Dataelement, 1 Språk
Item-grupper: Administration, Pre-vaccination assessment, Vaccine administration, Solicited adverse events - Local Symptoms, Redness, Swelling, Pain, Solicited adverse events - General symptoms, Fever, Fatigue, Headache, Gastrointestinal symptoms
Visit 2 Study ID: 101695 Ext. Mth30 Clinical Study ID: 101695 Study Title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00343915 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines Study ID: 101695 NCT00343915 - Visit 1: Day 0

- 2018-03-16 - 1 Formulär, 13 Item-grupper, 60 Dataelement, 1 Språk
Item-grupper: Administration, General medical history/physical examination, Pre-vaccination assessment, Vaccine administration, Solicited adverse events - Local Symptoms, Redness, Swelling, Pain, Solicited adverse events - General symptoms, Fever, Fatigue, Headache, Gastrointestinal symptoms
Visit 1 Study ID: 101695 Ext. Mth30 Clinical Study ID: 101695 Study Title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00343915 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065 - Visit 1: General Medical History

- 2018-12-05 - 1 Formulär, 16 Item-grupper, 30 Dataelement, 1 Språk
Item-grupper: Administrative data, Physical Examination, Cutaneous, Eyes, Ears-Nose-Throat, Cardiovascular, Respiratory, Gastrointestinal, Muskuloskeletal, Neurological, Genitourinary, Haematology, Allergies, Endocrine, Persistent crying, Other, specify
Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

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