ID

36104

Description

Study ID: 107007 Clinical Study ID: 107007 Study Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00344318 https://clinicaltrials.gov/ct2/show/NCT00344318 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal conjugate vaccine GSK1024850A Trade Name: Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin., Poliorix Study Indication: Infections, Streptococcal This study consists of 2 groups of probands (Children of 6-10-14 weeks or 2-4-6 months of age are included): One group receive a 3-dose primary vaccination with the GSK Biologicals' (10-valent) pneumococcal conjugate vaccine. The other group r eceive a 3-dose primary vaccination with Prevenar™. All probands receive DTPw-HBV/Hib and OPV or IPV vaccines. Ths study consists of 3 workbooks (WB): WB 1: The WB 1 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 1; Age for 10 weeks scheduled Visit 3, Timing: Month 2; Age for 14 weeks scheduled Visit 4, Timing: Month 3; Age for +/- 4 months scheduled Intervals between the visits: Visit 1 to Visit 2: 28-42 days, Visit 2 to Visit 3: 28-42 days, Visit 3 to Visit 4: 30-42 days WB 2: The WB 2 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 2; Age for +/- 4 months scheduled Visit 3, Timing: Month 4; Age for +/- 6 months scheduled Visit 4, Timing: Month 5; Age for +/- 7 months scheduled Intervals between the visits: Visit 1 to Visit 2: 49-83 days, Visit 2 to Visit 3: 49-83 days, Visit 3 to Visit 4: 30-42 days WB 3: The WB 3 consists the phone contact (6 months safety follow-up), Timing: Month 8 or 10. This document contains the Vaccine Administration form. It has to be filled in for Visit 1-3.

Link

https://clinicaltrials.gov/ct2/show/NCT00344318

Keywords

Versions (2)
  1. 4/9/19 4/9/19 -
  2. 4/15/19 4/15/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Safety, reactogenicity and immunogenicity 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines in infants, NCT00344318

English

Vaccine Administration

1 forms  
  1. StudyEvent: ODM
    1. Vaccine Administration
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Workbook Number
Description

Workbook Number

Data type

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Vaccine administration
Description

Vaccine administration

Alias
UMLS CUI-1
C2368628
Date of vaccine administration
Description

day month year. (fill in only if different from visit date).

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Pre-Vaccination temperature
Description

Pre-Vaccination temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0042196
°C
Route of temperature measurement
Description

Route of temperature measurement

Data type

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Vaccine
Description

(only one box must be ticked by vaccine). NOTE: "OPV Vaccine" is for workbook 1. "IPV Vaccine" is for wokbook 2. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.

Data type

integer

Alias
UMLS CUI [1]
C0042210
Vaccine administration
Description

If you tick "not administered", please complete following Itemgroup.

Data type

text

Alias
UMLS CUI [1]
C2368628
If replacement vial, please note the replacement vial Identifier
Description

Replacement vial Identifier

Data type

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
If wrong vial, please note the wrong vial number
Description

Wrong vial number

Data type

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C3827420
Side / site route of Vaccination according to the protocol
Description

According to the protocol: -For 10Pn-PD-DiT or Prevenar Vaccine take the right thigh I.M. -For DTPw-HBV/Hib Vaccine take the left upper thigh I.M. -For OPV Vaccine administer oral -For IPV Vaccine take the left lower thigh I.M. If you administered differently than protocol intended tick "Not according to the protocol".

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C0013153
UMLS CUI [2,2]
C0441987
UMLS CUI [2,3]
C2348563
If study vaccine has NOT been administered according to the Protocol, please tick appropriate side.
Description

Vaccine administration NOT according to the Protocol: Side

Data type

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
If study vaccine has NOT been administered according to the Protocol, please tick appropriate site.
Description

For 10Pn-PD-DiT or Prevenar Vaccine: Deltoid, Thigh, Buttock For DTPw-HBV/Hib Vaccine: Deltoid, Upper thigh, Lower thigh, Buttock For IPV: Deltoid, Upper thigh, Lower thigh, Buttock

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
If study vaccine has NOT been administered according to the Protocol, please tick appropriate route.
Description

OPV is excluded.

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
No vaccine administration
Description

No vaccine administration

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C1272696
Vaccine
Description

Vaccine

Data type

integer

Alias
UMLS CUI [1]
C0042210
If vaccine was not administered, please tick the major reason for non administration
Description

If you tick SAE: Please complete and submit SAE report If you tick AEX: Please complete Non-serious Adverse Event section If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event report. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0566251
If you ticked SAE as major reason for non administration, please specify SAE Identifier
Description

SAE Identifier

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
If you ticked AE as major reason for non administration, please specify AE Identifier
Description

AE Identifier

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
If you ticked other as major reason for non administration, please specify
Description

(e.g.: consent withdrawal, Protocol violation, …)

Data type

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1272696
Please tick who made the decision
Description

Decision taken

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1272696
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Similar models

Vaccine Administration

1 forms
  1. StudyEvent: ODM
    1. Vaccine Administration
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
Workbook Number
integer
C2986015 (UMLS CUI [1])
Workbook Number
Code List
Workbook Number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Workbook Number
Code List
Visit type
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vaccine administration
C2368628 (UMLS CUI-1)
Date of vaccine administration
Item
Date of vaccine administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Item
Route of temperature measurement
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Route of temperature measurement
Code List
Route of temperature measurement
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
CL Item
Tympanic (oral conversion) (X)
CL Item
Tympanic (rectal conversion) (Y)
Item
Vaccine
integer
C0042210 (UMLS CUI [1])
Vaccine
Code List
Vaccine
CL Item
10Pn-PD-DiT or Prevenar Vaccine (1)
CL Item
DTPw-HBV/Hib Vaccine (2)
CL Item
OPV Vaccine (3)
CL Item
IPV Vaccine (4)
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
CL Item
as planned (S)
Replacement vial Identifier
Item
If replacement vial, please note the replacement vial Identifier
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
If wrong vial, please note the wrong vial number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
Item
Side / site route of Vaccination according to the protocol
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0013153 (UMLS CUI [2,1])
C0441987 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
Side / site route of Vaccination
Code List
Side / site route of Vaccination according to the protocol
CL Item
Left (L)
CL Item
Right (R)
CL Item
Oral (O)
CL Item
Not according to the protocol (NA)
Item
If study vaccine has NOT been administered according to the Protocol, please tick appropriate side.
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine administration according to the Protocol
Code List
If study vaccine has NOT been administered according to the Protocol, please tick appropriate side.
CL Item
Left (L)
CL Item
Right (R)
Item
If study vaccine has NOT been administered according to the Protocol, please tick appropriate site.
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine administration according to the Protocol
Code List
If study vaccine has NOT been administered according to the Protocol, please tick appropriate site.
CL Item
Deltoid (1)
CL Item
Thigh  (2)
CL Item
Upper thigh (3)
CL Item
Lower thigh (4)
CL Item
Buttock (5)
Item
If study vaccine has NOT been administered according to the Protocol, please tick appropriate route.
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccine administration according to the Protocol
Code List
If study vaccine has NOT been administered according to the Protocol, please tick appropriate route.
CL Item
I.M. (IM)
CL Item
S.C. (SC)
Item Group
No vaccine administration
C2368628 (UMLS CUI-1)
C1272696 (UMLS CUI-2)
Item
Vaccine
integer
C0042210 (UMLS CUI [1])
Vaccine
Code List
Vaccine
CL Item
10Pn-PD-DiT or Prevenar Vaccine (1)
CL Item
DTPw-HBV/Hib Vaccine (2)
CL Item
OPV Vaccine (3)
CL Item
IPV Vaccine (4)
Item
If vaccine was not administered, please tick the major reason for non administration
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Major reason for non administration
Code List
If vaccine was not administered, please tick the major reason for non administration
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
SAE Identifier
Item
If you ticked SAE as major reason for non administration, please specify SAE Identifier
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AE Identifier
Item
If you ticked AE as major reason for non administration, please specify AE Identifier
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Other reason
Item
If you ticked other as major reason for non administration, please specify
text
C3840932 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Please tick who made the decision
text
C0679006 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Decision taken
Code List
Please tick who made the decision
CL Item
Investigator (I)
CL Item
Parent/Guardians (P)
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