ID

35814

Description

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

Keywords

Versions (1)
  1. 3/25/19 3/25/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 25, 2019

DOI

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License

Creative Commons BY-NC 3.0
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GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

English

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Description

Administrative Data

Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Follow-Up Studies
Description

Follow-Up Studies

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

Follow-up Study, Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
No, please specify the most appropriate reason
Description

Follow-up Study, Study Subject Participation Status, Reason

Data type

text

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0566251
No, please specify the most appropriate reason
Description

Follow-up Study, Study Subject Participation Status, Reason

Data type

text

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0566251
Occurrence of Serious Adverse Event
Description

Occurrence of Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Did the subject experience any Serious Adverse Event during the booster phase ?
Description

Serious Adverse Event, During, Accelerated phase

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0457345
Yes -> Specify total number of SAE's
Description

Serious Adverse Event, Count of entities

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Elimination Criteria
Description

Elimination Criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable during the study ?
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
Yes -> Specify
Description

Exclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C0680251
Withdrawal
Description

Withdrawal

Alias
UMLS CUI-1
C2349954
Was the subject withdrawn from study ?
Description

Patient withdrawn from trial

Data type

text

Alias
UMLS CUI [1]
C0422727
Please tick the ONE most appropriate category for withdrawal.
Description

Patient withdrawn from trial, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3146298
Specification
Description

Patient withdrawn from trial, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3146298
Please tick who took decision
Description

Patient withdrawn from trial, Decision maker

Data type

text

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

Patient withdrawn from trial, Date last contact

Data type

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0805839
Was the subject in good condition at date of last contact?
Description

Patient withdrawn from trial, Date last contact, Condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0805839
UMLS CUI [1,3]
C0348080
Investigator's Signature
Description

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Description

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.

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Investigator Signature, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Investigator's name
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Follow-Up Studies
C0016441 (UMLS CUI-1)
Follow-up Study, Study Subject Participation Status
Item
If a booster study or a follow-up study is offered in the future, would the parents/guardians be willing to be contacted and learn more about it?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
No, please specify the most appropriate reason
text
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Follow-up Study, Study Subject Participation Status, Reason
Code List
No, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (Adverse Events, or Serious Adverse Events)
CL Item
Other (Other)
Item
No, please specify the most appropriate reason
text
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Follow-up Study, Study Subject Participation Status, Reason
Code List
No, please specify the most appropriate reason
Item Group
Occurrence of Serious Adverse Event
C1519255 (UMLS CUI-1)
Serious Adverse Event, During, Accelerated phase
Item
Did the subject experience any Serious Adverse Event during the booster phase ?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0457345 (UMLS CUI [1,3])
Serious Adverse Event, Count of entities
Item
Yes -> Specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
Elimination Criteria
C0680251 (UMLS CUI-1)
Exclusion Criteria
Item
Did any elimination criteria become applicable during the study ?
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Yes -> Specify
text
C0680251 (UMLS CUI [1])
Item Group
Withdrawal
C2349954 (UMLS CUI-1)
Patient withdrawn from trial
Item
Was the subject withdrawn from study ?
text
C0422727 (UMLS CUI [1])
Item
Please tick the ONE most appropriate category for withdrawal.
text
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Patient withdrawn from trial, Indication
Code List
Please tick the ONE most appropriate category for withdrawal.
CL Item
Serious adverse event (complete the Serious Adverse Event form), Please specify SAE N° (1)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section), Please specify unsolicited AE N°(Unsol.) or solicited AE code  (2)
CL Item
Protocol violation, please specify (3)
CL Item
Consent withdrawal, not due to an adverse event. (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up. (6)
CL Item
Other, please specify (7)
Item
Specification
text
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Patient withdrawn from trial, Indication
Code List
Specification
Item
Please tick who took decision
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Patient withdrawn from trial, Decision maker
Code List
Please tick who took decision
CL Item
Investigator  (1)
CL Item
Parents/Guardians (2)
Patient withdrawn from trial, Date last contact
Item
Date of last contact
date
C0422727 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
Patient withdrawn from trial, Date last contact, Condition
Item
Was the subject in good condition at date of last contact?
boolean
C0422727 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
C0348080 (UMLS CUI [1,3])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
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