ID

36102

Beschrijving

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 Follow-up studies, Study conclusion and Investigator's signature form. It has to be filled in for the end of study.

Link

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

Trefwoorden

Versies (2)
  1. 09-04-19 09-04-19 -
  2. 15-04-19 15-04-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

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15 april 2019

DOI

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Licentie

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

Engels

Follow-up studies, Study conclusion, Investigator's signature

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Workbook Number
Beschrijving

Workbook Number

Datatype

integer

Alias
UMLS CUI [1]
C2986015
Follow-up studies
Beschrijving

Follow-up studies

Alias
UMLS CUI-1
C0016441
If a booster study or a follow-up study is offered in the future, would the subject/parents/guardians be willing to be contacted and learn more about it?
Beschrijving

Follow-up studies, Contact

Datatype

text

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C0332158
UMLS CUI [2,1]
C0016441
UMLS CUI [2,2]
C0332158
UMLS CUI [2,3]
C0030551
UMLS CUI [3,1]
C0016441
UMLS CUI [3,2]
C0332158
UMLS CUI [3,3]
C0023226
If no contact desired, please specify the most appropriate reason
Beschrijving

Reason for no contact

Datatype

integer

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C0332158
UMLS CUI [1,4]
C0566251
Specification of reason
Beschrijving

Specification of reason

Datatype

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C2348235
Study conclusion
Beschrijving

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the subject experience any Serious Adverse Event during the study period?
Beschrijving

SAE during study period

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347804
If SAE, please specify total number of SAE's
Beschrijving

SAE Numbers

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Was the treatment blind broken during the study ?
Beschrijving

Treatment blind broken

Datatype

text

Alias
UMLS CUI [1]
C3897431
If treatment blind broken, complete date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3897431
If treatment blind broken, tick one reason
Beschrijving

Complete Non-Serious Adverse Event section or a Serious Adverse Event report as appropriate.

Datatype

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3897431
If other reason for treatment blind broken, please specify
Beschrijving

Other reason for treatment blind broken

Datatype

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C3897431
Did any elimination criteria become applicable during the study ?
Beschrijving

Elimination criteria

Datatype

text

Alias
UMLS CUI [1]
C0680251
If any elimination criteria became applicable, please specify
Beschrijving

Elimination criteria, specification

Datatype

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Was the subject withdrawn from the study ?
Beschrijving

Withdrawal of subject

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
If the subject was withdrawn, please tick the major reason for withdrawal
Beschrijving

tick one box only. If you tick SAE: Please complete and submit SAE report. If you tick AEX: Please complete Non-serious Adverse Event section.

Datatype

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0008976
If you tick SAE as major reason for withdrawal, please specify SAE Number
Beschrijving

SAE Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If you tick AE as major reason for withdrawal, please specify AE Number OR solicited AE code
Beschrijving

AE Number/ solicited AE code

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0600091
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0805701
If you tick protocol violation as major reason for withdrawal, please specify
Beschrijving

Protocol violation, specification

Datatype

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
If you tick other as major reason for withdrawal, please specify
Beschrijving

Other reason for withdrawal, specification

Datatype

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C2348235
Who made the decision?
Beschrijving

Decision taken

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Date of last contact
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact?
Beschrijving

If you tick No, please give details in Adverse Events section

Datatype

text

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Investigator's Signature
Beschrijving

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's Signature
Beschrijving

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Beschrijving

Printed Investigator's name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Date of signature
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Follow-up studies, Study conclusion, Investigator's signature

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Visit type
Code List
Workbook Number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
Item Group
Follow-up studies
C0016441 (UMLS CUI-1)
Item
If a booster study or a follow-up study is offered in the future, would the subject/parents/guardians be willing to be contacted and learn more about it?
text
C0016441 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0016441 (UMLS CUI [2,1])
C0332158 (UMLS CUI [2,2])
C0030551 (UMLS CUI [2,3])
C0016441 (UMLS CUI [3,1])
C0332158 (UMLS CUI [3,2])
C0023226 (UMLS CUI [3,3])
Follow-up studies, Contact
Code List
If a booster study or a follow-up study is offered in the future, would the subject/parents/guardians be willing to be contacted and learn more about it?
CL Item
Yes (Y)
CL Item
No (N)
Item
If no contact desired, please specify the most appropriate reason
integer
C0016441 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0332158 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Reason for no contact
Code List
If no contact desired, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
Specification of reason
Item
Specification of reason
text
C0566251 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Did the subject experience any Serious Adverse Event during the study period?
text
C1519255 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
SAE durind study period
Code List
Did the subject experience any Serious Adverse Event during the study period?
CL Item
Yes (Y)
CL Item
No (N)
SAE Numbers
Item
If SAE, please specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item
Was the treatment blind broken during the study ?
text
C3897431 (UMLS CUI [1])
Treatment blind broken
Code List
Was the treatment blind broken during the study ?
CL Item
Yes (Y)
CL Item
No (N)
Treatment blind broken, date
Item
If treatment blind broken, complete date
date
C0011008 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Item
If treatment blind broken, tick one reason
integer
C0566251 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Treatment blind broken, reason
Code List
If treatment blind broken, tick one reason
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (2)
Other reason for treatment blind broken
Item
If other reason for treatment blind broken, please specify
text
C3840932 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Item
Did any elimination criteria become applicable during the study ?
text
C0680251 (UMLS CUI [1])
Elimination criteria
Code List
Did any elimination criteria become applicable during the study ?
CL Item
No (N)
CL Item
Yes (Y)
Elimination criteria, specification
Item
If any elimination criteria became applicable, please specify
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
Was the subject withdrawn from the study ?
text
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Withdrawal of subject
Code List
Was the subject withdrawn from the study ?
CL Item
No (N)
CL Item
Yes (Y)
Item
If the subject was withdrawn, please tick the major reason for withdrawal
text
C1549995 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Withdrawal of subject, reason
Code List
If the subject was withdrawn, please tick the major reason for withdrawal
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Protocol violation (PTV)
CL Item
Consent withdrawal, not due to an adverse event (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other (OTH)
SAE Number
Item
If you tick SAE as major reason for withdrawal, please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number/ solicited AE code
Item
If you tick AE as major reason for withdrawal, please specify AE Number OR solicited AE code
integer
C1518404 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
Protocol violation, specification
Item
If you tick protocol violation as major reason for withdrawal, please specify
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other reason for withdrawal, specification
Item
If you tick other as major reason for withdrawal, please specify
text
C3840932 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Who made the decision?
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision taken
Code List
Who made the decision?
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact?
text
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Subject's condition
Code List
Was the subject in good condition at date of last contact?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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