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

- 10-06-19 - 1 Formulier, 13 Itemgroepen, 97 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Informed Consent, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, Randomization, Medical History; Physical Examination, Vaccines, Medical History, 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

Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix EudraCT Number 2006-000939-97 - Study Conclusion

- 29-05-19 - 1 Formulier, 6 Itemgroepen, 17 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Follow-Up Studies, Occurence of SAE, Elimination Criteria, Status of Treatment Blind, Investigators Signature

Study ID: 107191 Clinical Study ID: 107191 Study Title: A Phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with FluarixTM (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years. Patient Level Data: NA Clinicaltrials.gov Identifier: NA EudraCT Number: 2006-000939-97 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A Trade Name: FluarixTM Study Indication: Influenza The purpose of this form is to conclude the study. It should be filled out at the phone contact and rechecked at visit 3. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1 Visit 1 and 2 are part of the study: "Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373"

Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix EudraCT Number 2006-000939-97 - Tracking Document

- 29-05-19 - 1 Formulier, 3 Itemgroepen, 11 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Reason for Non Participation, Serious Adverse Event

Study ID: 107191 Clinical Study ID: 107191 Study Title: A Phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with FluarixTM (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years. Patient Level Data: NA Clinicaltrials.gov Identifier: NA EudraCT Number: 2006-000939-97 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A Trade Name: FluarixTM Study Indication: Influenza The purpose of this form is to document the reason for the subjects non-participation and if the subject has had any SAEs since the last contact. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1 Visit 1 and 2 are part of the study: "Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373"

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Visit 2 - Month 1

- 26-05-19 - 1 Formulier, 3 Itemgroepen, 8 Data-elementen, 1 Taal

Itemgroepen: Administrative Documentation, Continuation status, Clinical Trials, Collection of blood specimen for laboratory procedure

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Visit 1 - Month 0 - Vaccination

- 26-05-19 - 1 Formulier, 16 Itemgroepen, 87 Data-elementen, 1 Taal

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

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Diary Card - "6-30 years"

- 26-05-19 - 1 Formulier, 6 Itemgroepen, 35 Data-elementen, 1 Taal

Itemgroepen: Administrative Documentation, Adverse Event, Symptoms, Local, Symptoms, Local, Other, Adverse Event, General symptom, General symptom, Other, Pharmaceutical Preparations

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Diary Card - "2-5 years"

- 26-05-19 - 1 Formulier, 6 Itemgroepen, 35 Data-elementen, 1 Taal

Itemgroepen: Administrative Documentation, Adverse Event, Symptoms, Local, Symptoms, Local, Other, Adverse Event, General symptom, General symptom, Other, Pharmaceutical Preparations

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Study Conclusion

- 26-05-19 - 1 Formulier, 7 Itemgroepen, 18 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Serious Adverse Event, Pregnancy, Information, Treatment Status, Blinded Clinical Study, Exclusion Criteria, Withdraw, Investigator Signature

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Non-Serious Adverse Events

- 26-05-19 - 1 Formulier, 2 Itemgroepen, 11 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Non-serious Adverse Event

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463 - Visit 4

- 26-05-19 - 1 Formulier, 3 Itemgroepen, 8 Data-elementen, 1 Taal

Itemgroepen: Administrative Documentation, Continuation status, Clinical Trials, Collection of blood specimen for laboratory procedure

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

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Concomitant Vaccination

- 26-05-19 - 1 Formulier, 2 Itemgroepen, 5 Data-elementen, 1 Taal

Itemgroepen: Administrative Documentation, Concomitant Agent, Vaccination

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

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

- 26-05-19 - 1 Formulier, 15 Itemgroepen, 84 Data-elementen, 1 Taal

Itemgroepen: 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

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