Information:
Fel:
ID
24715
Beskrivning
Study ID: 100478 Clinical Study ID: 100478 Study Title: Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290303 Sponsor: GlaxoSmithKline 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 This form contains the PRE STUDY CONTACT VISIT
Nyckelord
Versioner (1)
- 2017-08-14 2017-08-14 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
14 augusti 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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GSK non-inferiority of Tritanrix Hepatitis B PRE STUDY CONTACT VISIT NCT00290303
GSK non-inferiority of Tritanrix Hepatitis B PRE STUDY CONTACT VISIT NCT00290303
Similar models
GSK non-inferiority of Tritanrix Hepatitis B PRE STUDY CONTACT VISIT NCT00290303
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Timing
Item
Timing
date
C0449243 (UMLS CUI [1])
Sampling time point
Item
Sampling time point
text
C0427352 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
CL Item
African Heritage / African American (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other, specify: (10)
Race other
Item
Other, specify:
text
C0034510 (UMLS CUI [1])
Item Group
PROTOCOL REQUIRED CONCOMITANT VACCINATION
C2347852 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI-2)
administered
Item
Have the MMR incentive vaccine been administered ?
boolean
C0065828 (UMLS CUI [1])
MMR INCENTIVE
Item
MMR INCENTIVE
boolean
C0065828 (UMLS CUI [1,1])
C0021147 (UMLS CUI [1,2])
C0021147 (UMLS CUI [1,2])
different from visit date
Item
Please complete only if different from visit date:
date
Item
INTENSITY FOR SOLICITED SYMPTOMS Pain at injection site
integer
C0877248 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries / protests on touch (2)
CL Item
Cries when limb is moved / spontaneously painful (3)
Item
INTENSITY FOR SOLICITED SYMPTOMS Drowsiness
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
INTENSITY FOR SOLICITED SYMPTOMS Irritability / fussiness
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
INTENSITY FOR SOLICITED SYMPTOMS Loss of appetite
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. = interfering with everyday activities. (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities (3)
CL Item
(In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice). (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice). (4)
CAUSALITY / RELATIONSHIP TO INVESTIGATIONAL PRODUCTS
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product? NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event.
boolean
C0013230 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
Recovered / Resolved (1)
CL Item
Recovering / Resolving: Subject is recovering at the time she/he completes the study or at the time she/he withdraws from study. (2)
CL Item
Not recovered / Not resolved: AE is ongoing at the time the subject completes the study or becomes lost to follow-up; in case of death AEs that are not the cause of death. (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
CL Item
Fatal: AE is the cause of death (only applicable for SAE reports) (5)
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