ID

30011

Description

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix-HepB/Hib-MenAC vaccine as compared to Tritanrix-HepB/Hib2.5 + Meningitec™ when administered to healthy infants at 6, 10, 14 weeks of age, who have received a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: 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 Documentation part: Visit 1, Day 0, HBV Birth Dose

Keywords

Versions (2)
  1. 7/10/17 7/10/17 -
  2. 5/4/18 5/4/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

May 4, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Visit 1 759346/004

English

Visit 1 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

1 forms  
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0042210
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Informed Consent Date
Description

I certify that Informed Consent has been obtained prior to any study procedure.

Data type

time

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C0042210
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
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Race, if other please specify
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C1516637
UMLS CUI-2
C0042210
Did the subject meet all the entry criteria?
Description

If No, please complete below.

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Tick the boxes corresponding to any of the inclusion criteria the subject failed

Data type

integer

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Description

Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.

Data type

integer

Alias
UMLS CUI [1]
C0680251
Hepatitis B Vaccine
Description

Hepatitis B Vaccine

Alias
UMLS CUI-1
C2240392
Has the Hepatitis B vaccine been administered ?
Description

Hepatitis B vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C2240392
UMLS CUI [1,2]
C2368628
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Similar models

Visit 1 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
time
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C0011298 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
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
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
CL Item
Other, please specify (6)
Race
Item
Race, if other please specify
text
C0034510 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item
Inclusion Criteria
integer
C1512693 (UMLS CUI [1])
Inclusion Criteria
Code List
Inclusion Criteria
CL Item
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. (1)
CL Item
Written informed consent obtained from the parent or guardian of the subject (2)
CL Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study. (3)
CL Item
Born after a gestation period of 36 to 42 weeks (4)
CL Item
A male or female less than or equal to 3 days (72 hours) of age at the time of the birth dose of hepatitis B vaccine. (5)
Item
Exclusion Criteria
integer
C0680251 (UMLS CUI [1])
Exclusion Criteria
Code List
Exclusion Criteria
CL Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (1)
CL Item
A family history of congenital or hereditary immunodeficiency. (2)
CL Item
Major congenital defects or serious chronic illness. (3)
CL Item
History of any neurologic disorders or seizures. (4)
CL Item
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. (5)
CL Item
Acute disease at the time of enrolment (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature <37.5°C or rectal temperature <38.0°C). (6)
CL Item
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes. (7)
Item Group
Hepatitis B Vaccine
C2240392 (UMLS CUI-1)
Hepatitis B vaccine
Item
Has the Hepatitis B vaccine been administered ?
boolean
C2240392 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
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