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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

- 04/05/2018 - 1 Formulário, 10 Grupos de itens, 213 Elementos de dados, 1 Idioma

Grupos de itens: 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

- 04/05/2018 - 1 Formulário, 9 Grupos de itens, 182 Elementos de dados, 1 Idioma

Grupos de itens: 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

- 04/05/2018 - 1 Formulário, 1 Grupo de itens, 7 Elementos de dados, 1 Idioma

Grupo de itens: 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 1 759346/004 - Visit 1 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

- 04/05/2018 - 1 Formulário, 4 Grupos de itens, 12 Elementos de dados, 1 Idioma

Grupos de itens: Informed Consent, Demographics, Eligibility Question, Hepatitis B Vaccine

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 1, Day 0, HBV Birth Dose

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

- 04/05/2018 - 1 Formulário, 9 Grupos de itens, 182 Elementos de dados, 1 Idioma

Grupos de itens: 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

- 04/05/2018 - 1 Formulário, 2 Grupos de itens, 19 Elementos de dados, 1 Idioma

Grupos de itens: 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

- 04/05/2018 - 1 Formulário, 1 Grupo de itens, 5 Elementos de dados, 1 Idioma

Grupo de itens: Concomitant Vaccination

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: Concomitant Vaccination

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

- 04/05/2018 - 1 Formulário, 1 Grupo de itens, 9 Elementos de dados, 1 Idioma

Grupo de itens: Medication

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: Medication

Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec Non-Serious Adverse Events 100480 - Non-Serious Adverse Events Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480

- 04/05/2018 - 1 Formulário, 1 Grupo de itens, 14 Elementos de dados, 1 Idioma

Grupo de itens: Non-serious Adverse Events

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: Non-Serious Adverse Events

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

- 04/05/2018 - 1 Formulário, 3 Grupos de itens, 23 Elementos de dados, 1 Idioma

Grupos de itens: Follow-up Studies, Study Conclusion, Status of Treatment Blind

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: Study Conclusion

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Visit 1 100791 - Visit 1 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

- 04/05/2018 - 1 Formulário, 8 Grupos de itens, 142 Elementos de dados, 1 Idioma

Grupos de itens: Informed Consent, Demographics, Eligibility Question, General Medical History / Physical Examination, Vaccine Administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hib-MenAC 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 blinded, 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/Hiberix™ when administered to healthy infants at 2, 4, 6 months 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 1, Month 0, Dose 1

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Non-Serious Adverse Events 759346/004 - Non-Serious Adverse Events Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004