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Meningococcal Infections Vaccination in children NCT00196976 - Workbook 2 Visit 3 Part 1

- 08/11/2017 - 1 Formulaire, 4 Groupes Item, 12 Eléments de données, 1 Langue

Groupes Item: Administrative Documentation, Elimination Criteria, Demographics, Serious Adverse Events

Study ID: 103534 Clinical Study ID: 103534 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 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 GSK’s Clinical Study Register is no longer maintained for this study.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-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal CRF Seiten: 599-679 & 1063-1112 Booster Vaccination Only for subjects who are part of the group with the selected MenACWY-TT formulation and the control group.) “Subjects enrolled at 3 – 5 years of age” Previous study : 103533 (MenACWY-TT-010) Same subject number as previous study

Meningococcal Infections Vaccination in children NCT00196976 - Workbook 1 Visit 4 Part 1

- 08/11/2017 - 1 Formulaire, 6 Groupes Item, 24 Eléments de données, 1 Langue

Groupes Item: Administrative Documentation, Exclusion Criteria, Contraindications, Contraindications, Demographics, Serious Adverse Events

Study ID: 103534 Clinical Study ID: 103534 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 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-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal CRF Seiten: 599-679 & 1063-1112 Booster Vaccination (Only for subjects who are part of the group with the selected MenACWY-TT formulation and the control group.) “Subjects enrolled at 12 – 14 months of age”

Meningococcal Infections Vaccination in children NCT00196976 - Workbook 2 Visit 1 Part 1

- 03/11/2017 - 1 Formulaire, 7 Groupes Item, 29 Eléments de données, 1 Langue

Groupes Item: Administrative Documentation, Informed consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, Randomisation/ Treatment Allocation

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 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-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal CRF Seiten: 599-679 & 1063-1112

Meningococcal Infections Vaccination in children NCT00196976 - Workbook 1 Visit 1 Part 1

- 03/11/2017 - 1 Formulaire, 7 Groupes Item, 29 Eléments de données, 1 Langue

Groupes Item: Administrative Documentation, Informed consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, Randomisation/ Treatment Allocation

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 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-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal CRF Seiten: 599-679 & 1063-1112

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

- 26/05/2019 - 1 Formulaire, 15 Groupes Item, 84 Eléments de données, 1 Langue

Groupes Item: 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

Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727 - Visit 1 104727 ( DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months) ) - Informed Consent, Check Inclusion and Exclusion criteria, Demography, Randomisation/ Treatment Allocation

- 22/01/2019 - 1 Formulaire, 6 Groupes Item, 27 Eléments de données, 1 Langue

Groupes Item: Informed Consent, Demographics, Eligibility Check, Inclusion Criteria Violation, Exclusion Criteria Violation, Randomization/ Treatment Allocation

Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Sponsor: GlaxoSmithKline 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

Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727 - Visit 1 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M) - Informed Consent, Check Inclusion and Exclusion criteria, Demography, Randomisation/ Treatment Allocation

- 22/01/2019 - 1 Formulaire, 6 Groupes Item, 27 Eléments de données, 1 Langue

Groupes Item: Informed Consent, Demographics, Eligibility Check, Inclusion Criteria Violation, Exclusion Criteria Violation, Randomization/ Treatment Allocation

Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Sponsor: GlaxoSmithKline 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

Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B - Visit 1

- 05/01/2019 - 1 Formulaire, 10 Groupes Item, 45 Eléments de données, 1 Langue

Groupes Item: Administrative documentation, Informed Consent, Demographics Domain, Eligibility Determination, Medical History, Physical Examination, Vaccination, Before, Evaluation, Laboratory Procedures, Administration of vaccine, Vaccination, Adverse event, Symptoms, Local, Vaccination, Adverse Event, General symptom

Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Vaccination against pneumonia and otitis media, NCT00466947 - Demographics, administrative data, race

- 23/10/2018 - 1 Formulaire, 5 Groupes Item, 15 Eléments de données, 1 Langue

Groupes Item: Administrative data, INFORMED CONSENT, RANDOMISATION / TREATMENT ALLOCATION, Demographics, ORIGINE

Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00466947: https://clinicaltrials.gov/ct2/show/NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains information about demography, administrative data and origin. It has to be filled out in all workbooks for vist 1.

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