ID

32299

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 https://clinicaltrials.gov/ct2/show/NCT00466947 https://clinicalstudydatarequest.com/Posting.aspx?ID=2809 Clinicaltrials.gov Identifier: 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 protocol required concomitant vaccination. It has to be filled in for Visit 5 and 8. In Visit 8 only HAV has to be administered. It's for all workbooks. The document also contains the convulsion episode. It's for all workbooks and has to be filled in only in Visit 8.

Link

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

Keywords

Versions (3)
  1. 2018-10-23 2018-10-23 -
  2. 2018-10-26 2018-10-26 -
  3. 2018-10-26 2018-10-26 -
Copyright Holder

GlaxoSmithKline

Uploaded on

26 oktober 2018

DOI

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License

Creative Commons BY-NC 3.0
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Vaccination against pneumonia and otitis media, NCT00466947

English

Protocol required concomitant vaccination, convulsion episode

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit number
Description

Visit number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Description

Workbook number

Data type

integer

Alias
UMLS CUI [1]
C2986015
PROTOCOL REQUIRED CONCOMITANT VACCINATION
Description

PROTOCOL REQUIRED CONCOMITANT VACCINATION

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0042196
UMLS CUI-3
C1708545
Have the following protocol required concomitant vaccines been administered?
Description

If Yes is ticked, the applicable vaccine is not to be reported again in the Concomitant Vaccination section at the end of the CRF. Any other vaccines administered during the study period are to be recorded in the Concomitant Vaccination section at the end of the CRF. Reminder: Any vaccine should be administered at least 30 days before the date of study vaccine administration.

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C1708545
UMLS CUI [1,4]
C2368628
Vaccines
Description

In visit 8 only HAV vaccine

Data type

integer

Alias
UMLS CUI [1]
C0042210
Date if different from visit date
Description

Vaccine administration, Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
CONVULSION EPISODE
Description

CONVULSION EPISODE

Alias
UMLS CUI-1
C0332189
UMLS CUI-2
C4048158
Has the subject experienced any CONVULSION EPISODE occurring within 30 days after booster vaccination?
Description

If yes please complete the CONVULSION EPISODE section

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C4048158
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0042196
UMLS CUI [1,5]
C3259236
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Similar models

Protocol required concomitant vaccination, convulsion episode

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
CL Item
Visit 7 (7)
CL Item
Visit 8 (8)
CL Item
Visit 9 (9)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
workbook 1 (1)
CL Item
workbook 2 (2)
CL Item
workbook 3 (3)
Item Group
PROTOCOL REQUIRED CONCOMITANT VACCINATION
C2347852 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C1708545 (UMLS CUI-3)
Administration of protocol required concomitant vaccines
Item
Have the following protocol required concomitant vaccines been administered?
boolean
C2347852 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C1708545 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,4])
Item
Vaccines
integer
C0042210 (UMLS CUI [1])
Vaccines
Code List
Vaccines
CL Item
HAV vaccine (1)
CL Item
MMR vaccine (2)
CL Item
Meningococcal C conjugated vaccine (3)
Vaccine administration, Date
Item
Date if different from visit date
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item Group
CONVULSION EPISODE
C0332189 (UMLS CUI-1)
C4048158 (UMLS CUI-2)
Convulsion episode following booster vaccination
Item
Has the subject experienced any CONVULSION EPISODE occurring within 30 days after booster vaccination?
boolean
C0332189 (UMLS CUI [1,1])
C4048158 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C3259236 (UMLS CUI [1,5])
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