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Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec Visit 1 100480 - Visit 1 Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480

- 04/05/18 - 1 formulario, 14 itemgroups, 235 items, 1 idioma

Itemgroups: Informed Consent, Demographics, Eligibility Question, General Medical History / Physical Examination, Laboratory Tests, Pre-Vaccination Assessment, Vaccine Administration, Vaccine Administration, Multi Injections, Vaccine Administration, Multi Injections, Adverse Events, Post-Vaccination Observation, Solicited Adverse Events - Local Symptoms - Single Injection, Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hiberix vaccine, Solicited Adverse Events - Local Symptoms - Meningitec vaccine, Solicited Adverse Events - General Symptoms

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: Study to assess immunogenicity and non-inferiority of investigational vaccination regimen as compared to Tritanrix-HepB/Hiberix and as compared to Meningitec 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 1, Day 0, Dose 1

Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec Visit 2 100480 - Visit 2 Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480

- 04/05/18 - 1 formulario, 10 itemgroups, 197 items, 1 idioma

Itemgroups: Check for Study Continuation, Pre-Vaccination Assessment, Vaccine Administration, Vaccine Administration, Multi Injections, Vaccine Administration, Multi Injections, Adverse Events, Post-Vaccination Observation, Solicited Adverse Events - Local Symptoms - Single Injection, Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hiberix vaccine, Solicited Adverse Events - Local Symptoms - Meningitec vaccine, Solicited Adverse Events - General Symptoms

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: Study to assess immunogenicity and non-inferiority of investigational vaccination regimen as compared to Tritanrix-HepB/Hiberix and as compared to Meningitec 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 2, Month 2, 59-69 days after Visit 1, Dose 2

Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec Visit 3 100480 - Visit 3 Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480

- 04/05/18 - 1 formulario, 10 itemgroups, 198 items, 1 idioma

Itemgroups: Check for Study Continuation, Pre-Vaccination Assessment, Vaccine Administration, Vaccine Administration, Multi Injections, Vaccine Administration, Multi Injections, Adverse Events, Post-Vaccination Observation, Solicited Adverse Events - Local Symptoms - Single Injection, Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hiberix vaccine, Solicited Adverse Events - Local Symptoms - Meningitec vaccine, Solicited Adverse Events - General Symptoms

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: Study to assess immunogenicity and non-inferiority of investigational vaccination regimen as compared to Tritanrix-HepB/Hiberix and as compared to Meningitec 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 3, Month 4, 59-69 days after Visit 2, Dose 3

Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec Visit 4 100480 - Visit 4 Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480

- 04/05/18 - 1 formulario, 2 itemgroups, 9 items, 1 idioma

Itemgroups: Check for Study Continuation, Laboratory Tests

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: Study to assess immunogenicity and non-inferiority of investigational vaccination regimen as compared to Tritanrix-HepB/Hiberix and as compared to Meningitec 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 4, Month 5, 30-48 days after Visit 3

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Concomitant Vaccination 759346/004 - Concomitant Vaccination Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

- 04/05/18 - 1 formulario, 1 itemgroup, 5 items, 1 idioma

Itemgroup: Concomitant Vaccination

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix-HepB/Hib-MenAC vaccine as compared to Tritanrix-HepB/Hib2.5 + Meningitec™ when administered to healthy infants at 6, 10, 14 weeks of age, who have received a birth dose of hepatitis B vaccine. 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Concomitant Vaccination

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Medication 759346/004 - Medication Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

- 04/05/18 - 1 formulario, 1 itemgroup, 9 items, 1 idioma

Itemgroup: Medication

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix-HepB/Hib-MenAC vaccine as compared to Tritanrix-HepB/Hib2.5 + Meningitec™ when administered to healthy infants at 6, 10, 14 weeks of age, who have received a birth dose of hepatitis B vaccine. 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Medication

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Visit 2 759346/004 - Visit 2 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

- 04/05/18 - 1 formulario, 10 itemgroups, 213 items, 1 idioma

Itemgroups: Check for Study Continuation, General Medical History / Physical Examination, Pre-Vaccination Assessment, Vaccine Administration, Vaccine Administration, Adverse Events, Post-Vaccination Observation, Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib-MenAC vaccine, Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib vaccine, Solicited Adverse Events - Local Symptoms - MenC vaccine, Solicited Adverse Events - General Symptoms

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix-HepB/Hib-MenAC vaccine as compared to Tritanrix-HepB/Hib2.5 + Meningitec™ when administered to healthy infants at 6, 10, 14 weeks of age, who have received a birth dose of hepatitis B vaccine. 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 2, Month 1,5, 42-56 days after Visit 1, Dose 1

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Visit 3 759346/004 - Visit 3 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

- 04/05/18 - 1 formulario, 9 itemgroups, 182 items, 1 idioma

Itemgroups: Check for Study Continuation, Pre-Vaccination Assessment, Vaccine Administration, Vaccine Administration, Adverse Events, Post-Vaccination Observation, Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib-MenAC vaccine, Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib vaccine, Solicited Adverse Events - Local Symptoms - MenC vaccine, Solicited Adverse Events - General Symptoms

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix-HepB/Hib-MenAC vaccine as compared to Tritanrix-HepB/Hib2.5 + Meningitec™ when administered to healthy infants at 6, 10, 14 weeks of age, who have received a birth dose of hepatitis B vaccine. 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 3, Month 2,5, 28-42 days after Visit 2, Dose 2

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Visit 5 759346/004 - Visit 5 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

- 04/05/18 - 1 formulario, 1 itemgroup, 7 items, 1 idioma

Itemgroup: Check for Study Continuation

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix-HepB/Hib-MenAC vaccine as compared to Tritanrix-HepB/Hib2.5 + Meningitec™ when administered to healthy infants at 6, 10, 14 weeks of age, who have received a birth dose of hepatitis B vaccine. 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 5, Month 4,5, 28-42 days after Visit 4

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Visit 4 759346/004 - Visit 4 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

- 04/05/18 - 1 formulario, 9 itemgroups, 182 items, 1 idioma

Itemgroups: Check for Study Continuation, Pre-Vaccination Assessment, Vaccine Administration, Vaccine Administration, Adverse Events, Post-Vaccination Observation, Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib-MenAC vaccine, Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib vaccine, Solicited Adverse Events - Local Symptoms - MenC vaccine, Solicited Adverse Events - General Symptoms

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix-HepB/Hib-MenAC vaccine as compared to Tritanrix-HepB/Hib2.5 + Meningitec™ when administered to healthy infants at 6, 10, 14 weeks of age, who have received a birth dose of hepatitis B vaccine. 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 4, Month 3,5, 28-42 days after Visit 3, Dose 3

Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec Study Conclusion 100480 - Study Conclusion Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480

- 04/05/18 - 1 formulario, 2 itemgroups, 19 items, 1 idioma

Itemgroups: Study Conclusion, Status of Treatment Blind

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: Study to assess immunogenicity and non-inferiority of investigational vaccination regimen as compared to Tritanrix-HepB/Hiberix and as compared to Meningitec 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Study Conclusion

Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec Concomitant Vaccination 100480 - Concomitant Vaccination Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480