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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 Formulier, 14 Itemgroepen, 235 Data-elementen, 1 Taal

Itemgroepen: 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 Formulier, 10 Itemgroepen, 197 Data-elementen, 1 Taal

Itemgroepen: 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 Formulier, 10 Itemgroepen, 198 Data-elementen, 1 Taal

Itemgroepen: 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 Formulier, 2 Itemgroepen, 9 Data-elementen, 1 Taal

Itemgroepen: 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

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

- 04-05-18 - 1 Formulier, 1 Itemgroep, 5 Data-elementen, 1 Taal

Itemgroep: 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

- 04-05-18 - 1 Formulier, 1 Itemgroep, 9 Data-elementen, 1 Taal

Itemgroep: 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

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix Study Conclusion 100791 - Study Conclusion Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

- 04-05-18 - 1 Formulier, 3 Itemgroepen, 23 Data-elementen, 1 Taal

Itemgroepen: 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 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: Study Conclusion

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix Concomitant Vaccination 100791 - Concomitant Vaccination Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

- 04-05-18 - 1 Formulier, 1 Itemgroep, 5 Data-elementen, 1 Taal

Itemgroep: Concomitant Vaccination

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: Concomitant Vaccination

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix Medication 100791 - Medication Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

- 04-05-18 - 1 Formulier, 1 Itemgroep, 9 Data-elementen, 1 Taal

Itemgroep: Medication

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: Medication

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix Non-Serious Adverse Events 100791 - Non-Serious Adverse Events Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

- 04-05-18 - 1 Formulier, 1 Itemgroep, 13 Data-elementen, 1 Taal

Itemgroep: Non-serious Adverse Events

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: Non-Serious Adverse Events

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix Visit 2 100791 - Visit 2 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

- 04-05-18 - 1 Formulier, 6 Itemgroepen, 105 Data-elementen, 1 Taal

Itemgroepen: Check for Study Continuation, Pre-Vaccination Assessment, Vaccine Administration, Adverse Events, Post-Vaccination Observation, Solicited Adverse Events - Local Symptoms, 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 2, Month 2, 56-69 days after Visit 1, Dose 2

Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix Visit 4 100791 - Visit 4 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

- 04-05-18 - 1 Formulier, 1 Itemgroep, 7 Data-elementen, 1 Taal

Itemgroep: Check for Study Continuation

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 4, Month 5, 30-48 days after Visit 3

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