ID

29003

Description

A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) given as a booster at 18-24 months of age to pre-term children who have received a three-dose primary immunization course with the same vaccine in study 217744/090.

Keywords

Versions (1)
  1. 2/20/18 2/20/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

February 20, 2018

DOI

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License

Creative Commons BY-NC 3.0
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DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) Study ID: 101518

English

Visit 1 Eligibility Check

2 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
Description

Compliance of Child

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0008059
A male or female 18-24 months of age at the time of the booster vaccination.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Subjects must have completed full three-dose primary vaccination course with InfanrixTMhexa in the study 217744/090 (DTPa-HBV-IPV-090).
Description

undefined item

Data type

text

Written informed consent obtained from the parent or guardian of the subject before study entry.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Free of obvious health problems as established by medical history and clinical examination before entering into the study
Description

Comorbidity, Medical history

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0009488
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster vaccination, or planned use during the study period.
Description

other medication during study

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination since the study conclusion visit of study DTPa-HBV-IPV-090.
Description

Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib

Data type

boolean

Alias
UMLS CUI [1]
C0121772
UMLS CUI [2]
C0012546
UMLS CUI [3]
C0039614
UMLS CUI [4]
C0043167
UMLS CUI [5]
C0032371
Evidence of previous or intercurrent, diphtheria, tetanus, pertussis hepatitis B, polio and/or Hib disease.
Description

Evidence of previous or intercurrent, diphtheria, tetanus, pertussis hepatitis B, polio and/or Hib disease

Data type

boolean

Alias
UMLS CUI [1]
C0121772
UMLS CUI [2]
C0012546
UMLS CUI [3]
C0039614
UMLS CUI [4]
C0043167
UMLS CUI [5]
C0032371
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Description

immunosuppressive or immunodeficient condition, HIV

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0021051
UMLS CUI [3]
C0019682
Planned administration/ administration of a vaccine not foreseen by the study protocol within the 30 days preceding the booster dose.
Description

other vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
(Planned) administration of immunoglobulins and/or any blood products during the study period starting 3 months before and ending 30 days after the booster vaccination.
Description

immunoglobulins and/or any blood products

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Description

immunosuppressants or other immune-modifying drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
Description

Seizures or progressive neurological disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C1335499
UMLS CUI [2]
C0036572
Major congenital defects or serious chronic illness.
Description

Major congenital defects or serious chronic illness.

Data type

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
Acute febrile illness (axillary temperature of ! 37.5°) at the time of planned vaccination (warrants deferral of the vaccination pending recovery of the subject).
Description

Acute febrile illness

Data type

boolean

Alias
UMLS CUI [1]
C0743842
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Description

medical history of hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
Any of the following adverse events having occurred after previous administration of DTP vaccine constitute a contraindication to the administration of the vaccine: - Hypersensitivity reaction due to the vaccine. - Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. - Fever ! 40 °C (axillary temperature) within 48 hours of vaccination. - Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination. - Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
Description

former adverse reactions to DTP vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0012559
UMLS CUI [1,2]
C0559546
UMLS CUI [2,1]
C0012559
UMLS CUI [2,2]
C1301624
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Similar models

Visit 1 Eligibility Check

2 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI-1)
Compliance of Child
Item
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
boolean
C1321605 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
Age
Item
A male or female 18-24 months of age at the time of the booster vaccination.
boolean
C0001779 (UMLS CUI [1])
undefined item
Item
Subjects must have completed full three-dose primary vaccination course with InfanrixTMhexa in the study 217744/090 (DTPa-HBV-IPV-090).
text
Informed consent
Item
Written informed consent obtained from the parent or guardian of the subject before study entry.
boolean
C0021430 (UMLS CUI [1])
Comorbidity, Medical history
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study
boolean
C0262926 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI-1)
other medication during study
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster vaccination, or planned use during the study period.
boolean
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib
Item
Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination since the study conclusion visit of study DTPa-HBV-IPV-090.
boolean
C0121772 (UMLS CUI [1])
C0012546 (UMLS CUI [2])
C0039614 (UMLS CUI [3])
C0043167 (UMLS CUI [4])
C0032371 (UMLS CUI [5])
Evidence of previous or intercurrent, diphtheria, tetanus, pertussis hepatitis B, polio and/or Hib disease
Item
Evidence of previous or intercurrent, diphtheria, tetanus, pertussis hepatitis B, polio and/or Hib disease.
boolean
C0121772 (UMLS CUI [1])
C0012546 (UMLS CUI [2])
C0039614 (UMLS CUI [3])
C0043167 (UMLS CUI [4])
C0032371 (UMLS CUI [5])
immunosuppressive or immunodeficient condition, HIV
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C0021079 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
other vaccine
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol within the 30 days preceding the booster dose.
boolean
C2368628 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
immunoglobulins and/or any blood products
Item
(Planned) administration of immunoglobulins and/or any blood products during the study period starting 3 months before and ending 30 days after the booster vaccination.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
immunosuppressants or other immune-modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Seizures or progressive neurological disease
Item
History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
boolean
C0027765 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2])
Major congenital defects or serious chronic illness.
Item
Major congenital defects or serious chronic illness.
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Acute febrile illness
Item
Acute febrile illness (axillary temperature of ! 37.5°) at the time of planned vaccination (warrants deferral of the vaccination pending recovery of the subject).
boolean
C0743842 (UMLS CUI [1])
medical history of hypersensitivity
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
former adverse reactions to DTP vaccine
Item
Any of the following adverse events having occurred after previous administration of DTP vaccine constitute a contraindication to the administration of the vaccine: - Hypersensitivity reaction due to the vaccine. - Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. - Fever ! 40 °C (axillary temperature) within 48 hours of vaccination. - Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination. - Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
boolean
C0012559 (UMLS CUI [1,1])
C0559546 (UMLS CUI [1,2])
C0012559 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
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