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Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727 - 104727 (DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months)) - Local symptoms; General Symptoms

- 1/23/19 - 1 form, 9 itemgroups, 91 items, 1 language
Itemgroups: Local Symptoms, DTPw/HBV/Hib Vaccine, DTPw/HBV/Hib Vaccine - Local Symptoms, Meningitec Vaccine , Meningitec Vaccine - Local symptoms, Other local Symptoms, General Symptoms, Other general symptoms, Medication
Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Patient Level Data:N/A Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727 - Visit 2 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18M)) - Reason for non participation; Local symptoms; General Symptoms

- 1/22/19 - 1 form, 6 itemgroups, 66 items, 1 language
Itemgroups: Tracking Document Reason for non participation, Administrative, Local Symptoms, Other local Symptoms, General Symptoms, Other general symptoms
Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Patient Level Data:N/A Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727 - Visit 1 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M)) - General Medical History/ Physical Examination; Vaccine Administration; Unsolicited adverse events; Solicited Adverse Events - Local Symptoms; Soliced adverse events - General Symptoms

- 1/22/19 - 1 form, 7 itemgroups, 89 items, 1 language
Itemgroups: General medical history/ Physical examination, Diagnosis, Baseline Measurement of mid left thigh circumference, Vaccine administration, Unsolicited Adverse events, Solicited Adverse Events - Local Symptoms, Soliced Adverse Events - General Symptoms
Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727 - Visit 1 104727 (DTPW-HBV=HIB-MENAC-TT-016 BST 013 (15/24M)) - General Medical History/ Physical Examination; Vaccine Administration; Unsolicited adverse events; Solicited Adverse Events - Local Symptoms; Soliced adverse events - General Symptoms

- 1/22/19 - 1 form, 12 itemgroups, 157 items, 1 language
Itemgroups: General medical history/ Physical examination, Diagnosis, Baseline Measurement of mid left thigh circumference, Protocol required concomitant vaccination, Vaccine administration - Single Injection, Vaccine Administration - Multi Injection, Unsolicited Adverse events, Solicited Adverse Events - Local Symptoms, Solicited adverse events - DTPw-HBV/Hib vaccine, Solicited adverse events - Meningitec vaccine, Soliced Adverse Events - General Symptoms, Unsolicited Adverse events
Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

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