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Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 19 Year 13)

- 2021-09-20 - 1 Formulär, 8 Item-grupper, 31 Dataelement, 1 Språk

Item-grupper: Introduction Information, General Information, Demographics, Laboratory tests, Study Conclusion, Serious Adverse Event, Investigator´s signature, Tracking Document

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

Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 20 Year 14)

- 2021-09-20 - 1 Formulär, 8 Item-grupper, 31 Dataelement, 1 Språk

Item-grupper: Introductional information, General Information, Demographics, Laboratory tests, Study Conclusion, Serious Adverse Event, Investigator´s signature, Tracking Document

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

Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 17 Year 11)

- 2021-09-20 - 1 Formulär, 8 Item-grupper, 30 Dataelement, 1 Språk

Item-grupper: Information, General Information, Demographics, Laboratory tests, Study Conclusion, Serious Adverse Event, Investigator´s signature, Tracking Document

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

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 15, Additional Vaccination) - Check for Study Continuation; General medical history/ Physical examination; Laboratory Tests; Vaccine Administration; Solicited Adverse Events - Local and General Symptoms; Unsolicited Adverse Events

- 2019-04-15 - 1 Formulär, 10 Item-grupper, 89 Dataelement, 1 Språk

Item-grupper: Administration, Check for Study Continuation , General Medical History / Physical Examination, Medical Condition, HCG Urine Pregnancy Test, Vaccine Administration, Vaccine Administration, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - General Symptoms, Unsolicited Adverse Events

Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline 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

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 14, Additional Vaccination) - Check for Study Continuation; General medical history/ Physical examination; Laboratory Tests; Vaccine Administration; Solicited Adverse Events - Local and General Symptoms; Unsolicited Adverse Events

- 2019-04-11 - 1 Formulär, 10 Item-grupper, 89 Dataelement, 1 Språk

Item-grupper: Administration, Check for Study Continuation , General Medical History / Physical Examination, Medical Condition, HCG Urine Pregnancy Test, Vaccine Administration, Vaccine Administration, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - General Symptoms, Unsolicited Adverse Events

Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline 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

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 13, Additional Vaccination) - General medical history/ Physical examination; Laboratory Tests; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

- 2019-04-11 - 1 Formulär, 10 Item-grupper, 85 Dataelement, 1 Språk

Item-grupper: Administration, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, HCG Urine Pregnancy Test, Vaccine Administration, Vaccine Administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - General Symptoms

Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline 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

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Visit 1 - Demographics; General Medical History; Laboratory Tests; Baseline Assessment; General Symptoms Observed Just Before Injection

- 2019-03-15 - 1 Formulär, 10 Item-grupper, 27 Dataelement, 1 Språk

Item-grupper: Administration, Demographics, Eligibility, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, Baseline Temperature, Baseline Assessment - General Symptoms, General Symptoms Observed Just Before Injection, General Symptoms Observed Just Before Injection

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline 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

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Visit 4 Dose 2 - Laboratory Tests; Baseline Temperature; Baseline Assessment; Vaccine Administration; Solicited Adverse Experiences - Local Symptoms and General Symptoms

- 2019-03-15 - 1 Formulär, 12 Item-grupper, 57 Dataelement, 1 Språk

Item-grupper: Administrative, Laboratory Tests, Baseline Temperature, Baseline Assessment- General Symptoms, General Symptoms Observed Just Before Injection, General Symptoms Observed Just Before Injection , Vaccine Administration, Solicited Adverse Experiences - Local Symptoms, Local Symptoms, Solicited Adverse Experiences - General Symptoms, General Symptoms - Only for children from 1 to 5 years old, General Symptoms - Only for children from 6 to 11 years old

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline 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

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Visit "Day 21"

- 2019-03-11 - 1 Formulär, 19 Item-grupper, 112 Dataelement, 1 Språk

Item-grupper: Administrative data, ELIMINATION CRITERIA, CHECK FOR STUDY CONTINUATION, LABORATORY TESTS, 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

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Visit 5 - Day 60 - Dose 2

- 2019-03-07 - 1 Formulär, 25 Item-grupper, 142 Dataelement, 1 Språk

Item-grupper: Administrative data, CHECK FOR STUDY CONTINUATION, HEMATOLOGY / BIOCHEMISTRY, HEMATOLOGY, BIOCHEMISTRY, LDH, URINALYSIS, Urinalysis (Dipstick) Test, RANDOMISATION / TREATMENT ALLOCATION, VACCINE ADMINISTRATION, VACCINE, VACCINE NON-ADMINISTRATION, IMMEDIATE POST-VACCINATION OBSERVATION, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, Temperature, Fatigue, Headache, Gastrointestinal symptoms, Malaise, Myalgia, UNSOLICITED ADVERSE EVENTS

Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Visit 1 - Day 0 - Dose 1

- 2019-03-06 - 1 Formulär, 25 Item-grupper, 142 Dataelement, 1 Språk

Item-grupper: Administrative data, CHECK FOR STUDY CONTINUATION, HEMATOLOGY / BIOCHEMISTRY, HEMATOLOGY, BIOCHEMISTRY, LDH, URINALYSIS, Urinalysis (Dipstick) Test, RANDOMISATION / TREATMENT ALLOCATION, VACCINE ADMINISTRATION, VACCINE, VACCINE NON-ADMINISTRATION, IMMEDIATE POST-VACCINATION OBSERVATION, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, Temperature, Fatigue, Headache, Gastrointestinal symptoms, Malaise, Myalgia, UNSOLICITED ADVERSE EVENTS

Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal

Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222 - Visit 3 (Month 2.5 28 – 42 days after Visit 2)

- 2019-02-28 - 1 Formulär, 17 Item-grupper, 199 Dataelement, 1 Språk

Item-grupper: Administrative data, CHECK FOR STUDY CONTINUATION, GENERAL MEDICAL HISTORY, PHYSICAL EXAMINATION, LABORATORY TESTS, VACCINE ADMINISTRATION, VACCINE ADMINISTRATION 2, VACCINE ADMINISTRATION 3, VACCINE NON-ADMINISTRATION, ADVERSE EVENTS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, LOCAL SYMPTOMS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific), DTPw-HBV Kft. vaccine, Hiberix™ vaccine, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, GENERAL SYMPTOMS

Study ID: 101222 Clinical Study ID: 101222 Study Title: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: 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 (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

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