Informações:
Falhas:
ID
23224
Descrição
Study ID: 100480 Clinical Study ID: 100480 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Visit 2: 30 – 42 days after Visit 1
Link
https://clinicaltrials.gov/ct2/show/NCT00317161
Palavras-chave
Versões (1)
- 29/06/2017 29/06/2017 -
Transferido a
29 de junho de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Visit 2 NCT00317161
Visit 2 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161
Similar models
Visit 2 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
Item
Did the subject return for visit 2 ?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Yes, please complete the next pages. (1)
CL Item
No, please specify (2)
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number or Code
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Other reason for Study Discontinuation
Item
Other reason for Study Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for study discontinuation
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Item Group
Protocol required Concomitant Vaccination
C2347852 (UMLS CUI-1)
C0771080 (UMLS CUI-2)
C0078048 (UMLS CUI-3)
C0771080 (UMLS CUI-2)
C0078048 (UMLS CUI-3)
Japanese encephalitis
Item
Japanese encephalitis
boolean
C0771080 (UMLS CUI [1])
Japanese encephalitis Date
Item
Japanese encephalitis Date
date
C0771080 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Varicella
Item
Varicella
boolean
C0078048 (UMLS CUI [1])
Varicella date
Item
Varicella date
date
C0078048 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Large Swelling Reaction
C0038999 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0443286 (UMLS CUI-3)
C0042196 (UMLS CUI-2)
C0443286 (UMLS CUI-3)
Item
Vaccine administered for which the large swelling reaction reported:
integer
C0042210 (UMLS CUI [1])
CL Item
DTPw-HBV/Hib-MenAC Vaccine (1)
CL Item
DTPw-HBV/Hib Vaccine (2)
CL Item
Meningitec Vaccine (3)
Date of physical examination
Item
Date of physical examination
date
C0031809 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
performer of examination
Item
Was the examination performed by a member of study personnel during the large swelling reaction period:
boolean
C0031809 (UMLS CUI [1,1])
C0025082 (UMLS CUI [1,2])
C0025082 (UMLS CUI [1,2])
Date when the swelling was first considered to be a large swelling reaction:
Item
Date when the swelling was first considered to be a large swelling reaction:
date
C0038999 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
hours after vaccination
Item
If occurring within 24 hours after vaccination, please specify how long after vaccination:
float
C0038999 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2])
C0439659 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2])
Size of swelling
Item
Measurement of the greatest diameter:
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
CL Item
Local swelling around injection site, not involving adjacent joint (1)
CL Item
Diffuse swelling, not involving adjacent joint (2)
CL Item
Swelling, involving adjacent joint (3)
Circumference
Item
Circumference of swollen limb (at the site of maximum swelling):
float
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
C0015385 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Circumference
Item
Circumference of the opposite limb (at the same level):
float
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0015385 (UMLS CUI [1,2])
Temperature
Item
Associated signs: Temperature
float
C0005903 (UMLS CUI [1])
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Redness
Item
Associated signs: Redness
boolean
C0332575 (UMLS CUI [1])
Redness largest diameter
Item
Redness, largest diameter
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
Induration
Item
Associated signs: Induration
boolean
C0332534 (UMLS CUI [1])
Induration largest diameter
Item
Induration, largest diameter
float
C0332534 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
Pain
Item
Associated signs: Pain (at administration site)
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
CL Item
grade 1, Minor reaction to touch (1)
CL Item
grade 2, Cries / protests on touch (2)
CL Item
grade 3, Cries when limb is move (3)
Functional impairment
Item
Associated signs: Functional impairment
boolean
C4062321 (UMLS CUI [1])
Item
Functional impairment, Intensity
integer
C4062321 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Grade 1, Easily tolerated, causing minimal discomfort and not interfering with everyday activities (1)
CL Item
Grade 2, Sufficiently discomforting to interfere with normal everyday activities (2)
CL Item
Grade 3, Prevents normal everyday activities (3)
Case description
Item
Case description
text
C0449437 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
C0678257 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
Last date of swelling
Item
Last date when the swelling was still considered to be large swelling reaction:
date
C0038999 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
duration swelling
Item
If lasting for less than 24 hours, please specify duration (hours):
float
C0038999 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Item
Outcome of the large swelling reaction: swelling reaction:
integer
C0085565 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,2])
Code List
Outcome of the large swelling reaction: swelling reaction:
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
alternative explanation
Item
Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
boolean
C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C0681841 (UMLS CUI [1,2])
alternative explanation
Item
Alternative explanation. If Yes, please specify
text
C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C0681841 (UMLS CUI [1,2])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
integer
C0042210 (UMLS CUI [1])
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date. (2)
Name
Item
Trade/Generic Name
text
C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Have any medications/treatments been administered during study period?
integer
C0013227 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0087111 (UMLS CUI [2])
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Medication name
Item
Trade or generic name
text
C2360065 (UMLS CUI [1])
Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Prophylactic
Item
Medical Indication: Prophylactic?
boolean
C0199176 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Medication Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Medication End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing: tick box if continuing at end of study
boolean
C2826666 (UMLS CUI [1])
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
C0042210 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
integer
C1518404 (UMLS CUI [1])
Code List
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
No (1)
CL Item
Yes, please complete the following table (2)
Adverse Event Number
Item
Adverse Event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Description
Item
Non-serious adverse events: Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Item
Non-serious adverse events: Description
integer
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
CL Item
Administration sites (1)
CL Item
Non-administration site (2)
Item
Non-serious adverse events: Description, Type of vaccine
integer
C0042210 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
C0332307 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
CL Item
DTPw-HBV/Hib-MenAC vaccine (1)
CL Item
DTPw-HBV/Hib vaccine (2)
CL Item
Meningitec vaccine (3)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Start
Item
Start: during immediate post-vaccination period (protocol specific: 0 – 30 minutes)
boolean
C0439659 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Modearte (2)
CL Item
Severe (3)
Relationship to investigational product(s)
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
Item
Medically attended visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2])
CL Item
Hospitalisation (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)