ID

24715

Description

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

Keywords

Versions (1)
  1. 8/14/17 8/14/17 -
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GlaxoSmithKline

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August 14, 2017

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Creative Commons BY-NC 3.0
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GSK non-inferiority of Tritanrix Hepatitis B PRE STUDY CONTACT VISIT NCT00290303

English

GSK non-inferiority of Tritanrix Hepatitis B PRE STUDY CONTACT VISIT NCT00290303

1 forms  
General Information
Description

General Information

Alias
UMLS CUI-1
C1508263
Age
Description

Age

Data type

integer

Alias
UMLS CUI [1]
C0001779
Visit
Description

Visit

Data type

integer

Alias
UMLS CUI [1]
C0545082
Timing
Description

Timing

Data type

date

Alias
UMLS CUI [1]
C0449243
Sampling time point
Description

Sampling time point

Data type

text

Alias
UMLS CUI [1]
C0427352
Subject Number
Description

PREVIOUS STUDY : 100478 (DTPW-HBV=HIB-MENAC-TT-011) Same subject number as primary study

Data type

text

Alias
UMLS CUI [1]
C2348585
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Description

Informed Consent Date

Data type

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Description

Center number

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Other, specify:
Description

Race other

Data type

text

Alias
UMLS CUI [1]
C0034510
PROTOCOL REQUIRED CONCOMITANT VACCINATION
Description

PROTOCOL REQUIRED CONCOMITANT VACCINATION

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0042196
Have the MMR incentive vaccine been administered ?
Description

administered

Data type

boolean

Alias
UMLS CUI [1]
C0065828
MMR INCENTIVE
Description

MMR INCENTIVE

Data type

boolean

Alias
UMLS CUI [1,1]
C0065828
UMLS CUI [1,2]
C0021147
Please complete only if different from visit date:
Description

different from visit date

Data type

date

Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
INTENSITY FOR SOLICITED SYMPTOMS Pain at injection site
Description

Pain at injection site

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2700396
UMLS CUI [1,3]
C0030193
INTENSITY FOR SOLICITED SYMPTOMS Drowsiness
Description

Drowsiness

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
INTENSITY FOR SOLICITED SYMPTOMS Irritability / fussiness
Description

Irritability / fussiness

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
INTENSITY FOR SOLICITED SYMPTOMS Loss of appetite
Description

Loss of appetite

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
INTENSITY FOR NON-SOLICITED SYMPTOMS
Description

NON SOLICITED SYMPTOMS

Data type

integer

Alias
UMLS CUI [1]
C0518690
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.
Description

CAUSALITY / RELATIONSHIP TO INVESTIGATIONAL PRODUCTS

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0877248
OUTCOME
Description

OUTCOME

Data type

integer

Alias
UMLS CUI [1]
C1705586
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Similar models

GSK non-inferiority of Tritanrix Hepatitis B PRE STUDY CONTACT VISIT NCT00290303

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
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])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
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)
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])
different from visit date
Item
Please complete only if different from visit date:
date
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
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])
Pain at injection site
Code List
INTENSITY FOR SOLICITED SYMPTOMS Pain at injection site
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])
Drowsiness
Code List
INTENSITY FOR SOLICITED SYMPTOMS Drowsiness
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])
Irritability / fussiness
Code List
INTENSITY FOR SOLICITED SYMPTOMS Irritability / fussiness
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])
Loss of appetite
Code List
INTENSITY FOR SOLICITED SYMPTOMS Loss of appetite
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)
Item
INTENSITY FOR NON-SOLICITED SYMPTOMS
integer
C0518690 (UMLS CUI [1])
NON-SOLICITED SYMPTOMS
Code List
INTENSITY FOR NON-SOLICITED SYMPTOMS
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])
Item
OUTCOME
integer
C1705586 (UMLS CUI [1])
OUTCOME
Code List
OUTCOME
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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