Search results - Portal of Medical Data Models (MDM-Portal)

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 13) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling

- 9/20/21 - 1 form, 5 itemgroups, 17 items, 1 language

Itemgroups: Administration, Demographics, Serious Adverse Events, Laboratory Tests, Serology Conclusion of the Blood Sampling Timepoint Year 12

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) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling

- 9/20/21 - 1 form, 5 itemgroups, 19 items, 1 language

Itemgroups: Administration, Demographics, Serious Adverse Events, Laboratory Tests, Serology Conclusion of the Blood Sampling Timepoint Year 13

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 12, Visit 1) - Informed Consent; Demographics; General medical history/ Physical examination; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

- 9/20/21 - 1 form, 12 itemgroups, 101 items, 1 language

Itemgroups: Administration, Demographics, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, HCG Urine Pregnancy Test, Blood Sample Conclusion, 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

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 12, Additional Vaccination) - Informed Consent; Demographics; Serious Adverse Event; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

- 9/24/19 - 1 form, 10 itemgroups, 87 items, 1 language

Itemgroups: Administration, Demographics, Serious Adverse Events, 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

DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463 - Visit 1 - Day 0 - Dose 1

- 5/26/19 - 1 form, 15 itemgroups, 84 items, 1 language

Itemgroups: Administrative Documentation, Exclusion Criteria, During, Clinical Trials, Vaccination, Medical contraindications, Informed Consent, Demographics Domain, Eligibility Determination, Inclusion, Exclusion Criteria, Randomization, Medical History, Physical Examination, Collection of blood specimen for laboratory procedure, Vaccination, Administration of Vaccine, Adverse Event, Symptoms, Local, Adverse Event, General symptom, Adverse Event, Vaccination

Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Month 60) - Demographics; Laboratory Tests; Follow-Up Studies; Safety Follow-Up - Serious Adverse Events; Tracking Document

- 3/18/19 - 1 form, 15 itemgroups, 76 items, 1 language

Itemgroups: Administrative, Demographics, Laboratory Tests, Follow-Up Studies, Investigator Signature, Serious Adverse Events, SAE - Study Vaccine Information (13), SAE - Concomitant medication / vaccination that could have contributed to this SAE (14), SAE - Relevant intercurrent illness & medical history that could have contributed to this SAE (15), Drug(s) used to treat this SAE (16), Surgical treatment for this SAE (17), Description (18), SAE - Comments, Tracking Document, Investigator signature

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 0" Vaccination

- 3/11/19 - 1 form, 29 itemgroups, 196 items, 1 language

Itemgroups: 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

Persistence of immune response of Hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers - Visit 22 - 26 (Follow-Up)

- 2/25/19 - 1 form, 17 itemgroups, 59 items, 1 language

Itemgroups: Visit 22 (Year 16) Follow-up, INFORMED CONSENT, DEMOGRAPHICS, Laboratory Tests, Visit 23 (Year 17) Follow-up, LABORATORY TESTS, Visit 24 (Year 18) Follow-up, LABORATORY TESTS, Visit 25 (Year 19) Follow-up, LABORATORY TESTS, Visit 26 (Year 20) Follow-up, LABORATORY TESTS, FOLLOW-UP STUDIES, INVESTIGATOR'S SIGNATURE, Reason for non participation, Tracking Document, Investigator's Signature

Study ID: 100449 Clinical Study ID: 100449 Study Title: Long-term Follow-Up studies at Years 16-20, to evaluate the persistence of immune response of GSK Biologicals’ hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00240539 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664 - Visit 2: No Boost Only (UK)

- 1/23/19 - 1 form, 19 itemgroups, 107 items, 1 language

Itemgroups: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Hib Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Vaccine Administration, Vaccine Administration - Vaccine 1, Vaccine Administration - Vaccine 2, Reason for non-administration, Unsolicited Adverse Events, Telephone Contact, Study Conclusion

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

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664 - Visit 1

- 1/11/19 - 1 form, 15 itemgroups, 94 items, 1 language

Itemgroups: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Hib Vaccination History, Pertussis Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Study Conclusion, Investigator's Confirmation

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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Pregnancy Outcome Form

- 11/21/18 - 1 form, 5 itemgroups, 35 items, 1 language

Itemgroups: Administrative data, Demography, Child Information, Pregnancy Outcome Information, Important Note

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

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