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Informed consent Visit 1 Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381 - Informed consent Visit 1

- 16/07/17 - 1 modulo, 1 ItemGroup, 4 elementi, 1 linguaggio
ItemGroup: Informed consent
Study part: Informed consent Visit 1. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

Eligibility Haemophilus Influenzae Type b Disease NCT00316680

- 17/09/21 - 1 modulo, 2 itemgroups, 9 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.; ODM derived from: https://clinicaltrials.gov/show/NCT00316680

Hib-MenAC vaccine administered intramuscularly in infants at 6 10 and 14 weeks of age - 104430 - Visit 5 ( Month 7.5)

- 15/03/21 - 1 modulo, 8 itemgroups, 30 elementi, 1 linguaggio
Itemgroups: Administrative data, ELIMINATION CRITERIA DURING THE STUDY, Contraindications and precautions for further doses, DEMOGRAPHICS, PRE-VACCINATION ASSESSMENT, THROAT SWAB (for subject’s parents/guardians), THROAT SWAB (for subject), VACCINE ADMINISTRATION
Study ID: 104430 Clinical Study ID: 104430 Study Title: A phase II, double blind, randomized, controlled study to evaluate the immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Hib-MenAC vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, as compared to GSK Biologicals’ Hiberix vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, when administered intramuscularly in infants at 6, 10 and 14 weeks of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1/2 Study Recruitment Status: Completed Generic Name: Hib-MenAC vaccine Trade Name: Tritanrix-HepB, Hiberix Study Indication: Immune, Inflammatory & Infections - Other

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056 - Miscellaneous Forms: Temperature Log, Adverse Events, Rash, Gland Swelling, Febrile Convulsions, Concomitant Medication

- 30/10/19 - 1 modulo, 13 itemgroups, 73 elementi, 1 linguaggio
Itemgroups: Administrative data, Temperature Log, Reminder, Rash / Exanthem, Rash Event Log, Parotid/Salivary Gland Swelling Events, Febrile Convulsions - Suspected Signs of Meningitis, Concomitant Vaccination, Concomitant Vaccination Details, Concomitant Medications, Concomitant Medications Details, Non-Serious Adverse Events, Non-Serious Adverse Events Log
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

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Eligibility

- 21/06/19 - 1 modulo, 2 itemgroups, 26 elementi, 1 linguaggio
Itemgroups: Exclusion Criteria, During, Clinical Trials, Vaccination, Medical contraindications
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Diary Card - Dose 1

- 21/06/19 - 1 modulo, 17 itemgroups, 139 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, General symptom, Vaccination, General symptom, Other, Pharmaceutical Preparations
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Diary Card - Dose 2

- 21/06/19 - 1 modulo, 17 itemgroups, 139 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, General symptom, Vaccination, General symptom, Other, Pharmaceutical Preparations
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Diary Card - Dose 3

- 21/06/19 - 1 modulo, 17 itemgroups, 139 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Vaccination, Symptoms, Local, Other, Vaccination, General symptom, Vaccination, General symptom, Other, Pharmaceutical Preparations
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Visit 1

- 21/06/19 - 1 modulo, 12 itemgroups, 82 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Demography, Eligibility Determination, Exclusion Criteria, Randomization, Medical History; Physical Examination, Vaccines, Medical History, Pharmaceutical Preparations, Medical History, Laboratory Procedures, Collection of blood specimen for laboratory procedure, Administration of vaccine, Administration of vaccine, Administration of Vaccine
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Visit 3

- 21/06/19 - 1 modulo, 7 itemgroups, 47 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Continuation Status, Clinical Trials, Laboratory Procedures, Administration of vaccine, Administration of vaccine, Administration of vaccine, Administration of Vaccine
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Visit 4

- 21/06/19 - 1 modulo, 3 itemgroups, 8 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Continuation Status, Clinical Trials, Laboratory Procedures
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Booster Dose

- 21/06/19 - 1 modulo, 9 itemgroups, 77 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Adverse Event, Vaccination, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Adverse Event, General symptom
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

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