ID

32092

Description

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 vaccination administration. It has to be filled in for Workbook 1,2 and 3. The vaccination administration has to be filled out in Visit 1,2,3 and 6. IMMEDIATE POST-VACCINATION OBSERVATION If any adverse events occurred during the immediate post-vaccination time (30 minutes) and cause the withdrawn to further vaccination, it should be detailed in the Non-Serious Adverse Event pages. If this adverse event is considered as a Serious Adverse Event, please complete a SAE report. In addition, if any Serious Adverse Event occurred during the immediate post-vaccination time (30 minutes), please fill in a Serious Adverse Event report. IMMEDIATE POST-VACCINATION OBSERVATION (FOR IMMUNO & REACTO SUBSET ONLY) If any solicited adverse event occurred during the immediate post vaccination time (30 minutes), please fill in the Solicited Adverse Events pages. If any adverse events occurred during the immediate post-vaccination time (30 minutes) and cause the withdrawn to further vaccination, it should be detailed in the Non-Serious Adverse Event pages. If this adverse event is considered as a Serious Adverse Event, please complete a SAE report. In addition, if any Serious Adverse Event occurred during the immediate post-vaccination time (30 minutes), please fill in a Serious Adverse Event report.

Link

https://clinicaltrials.gov/ct2/show/NCT00466947

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Versions (3)

1. 10/15/18 10/15/18 -
2. 10/17/18 10/17/18 -
3. 10/17/18 10/17/18 - Sarah Riepenhausen

Copyright Holder

GlaxoSmithKline

Uploaded on

October 17, 2018

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