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Visit 6 Booster Dose Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 10/15/17 - 1 form, 8 itemgroups, 35 items, 1 language
Itemgroups: Header, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Other General Symptoms
Visit 6 Booster Dose Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A 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

Visit 6 Booster Dose Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 10/15/17 - 1 form, 8 itemgroups, 35 items, 1 language
Itemgroups: Header, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Other General Symptoms
Visit 6 Booster Dose Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A 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

Visit 4 Dose 2 Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 10/15/17 - 1 form, 8 itemgroups, 35 items, 1 language
Itemgroups: Header, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Other General Symptoms
Visit 4 Dose 2 Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A 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

Visit 3 Dose 1 Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 8/29/17 - 1 form, 8 itemgroups, 35 items, 1 language
Itemgroups: Header, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Other General Symptoms
Visit 3 Dose 1 Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A 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

Visit 6 Booster Dose General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 8/25/17 - 1 form, 11 itemgroups, 63 items, 1 language
Itemgroups: Header, SOLICITED ADVERSE EXPERIENCES - GENERAL SYMPTOMS, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Seriousness of symptoms, V. OTHER GENERAL SYMPTOMS, Administrative Data
Visit 6 Booster Dose General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A 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

Visit 4 Dose 2 General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 8/24/17 - 1 form, 11 itemgroups, 63 items, 1 language
Itemgroups: Header, SOLICITED ADVERSE EXPERIENCES - GENERAL SYMPTOMS, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Seriousness of symptoms, V. OTHER GENERAL SYMPTOMS, Administrative Data
Visit 4 Dose 2 General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A 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

Visit 3 Dose 1 General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 8/24/17 - 1 form, 11 itemgroups, 63 items, 1 language
Itemgroups: Header, SOLICITED ADVERSE EXPERIENCES - GENERAL SYMPTOMS, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Seriousness of symptoms, V. OTHER GENERAL SYMPTOMS, Administrative Data
Visit 3 Dose 1 General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A 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

- 3/20/18 - 1 form, 12 itemgroups, 56 items, 1 language
Itemgroups: 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

Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021 - Visit 1: General Medical History

- 11/29/18 - 1 form, 16 itemgroups, 30 items, 1 language
Itemgroups: Administrative data, Physical Examination, Cutaneous, Eyes, Ears-Nose-Throat, Cardiovascular, Respiratory, Gastrointestinal, Muskuloskeletal, Neurological, Genitourinary, Haematology, Allergies, Endocrine, Persistent crying, Other, specify
Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

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