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Relevancia Evaluación Nuevo primero Antiguo primero

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

- 21/6/19 - 1 formulario, 13 itemgroups, 113 items, 1 idioma
Itemgroups: Administrative documentation, Adverse Event, Vaccination, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Vaccination, Adverse Event, Symptoms, Local, Adverse Event, General symptom
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

Vaccination against pneumonia and otitis media, NCT00466947 - Concomitant vaccination, Medication

- 27/10/18 - 1 formulario, 3 itemgroups, 13 items, 1 idioma
Itemgroups: Administrative data, CONCOMITANT VACCINATION, MEDICATION
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 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 the concomitant vaccination form. It has to be filled in if a concomitant vaccination occurs during study. It's for all workbooks. Any vaccine not foreseen in the study protocol administered during the entire study period is to be recorded with trade name, route of administration and date(s) of administration. The document also contains the medication form. It's only for workbook 2 ("for carriage subset only"). Only antibiotics are to be recorded in medication page.

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