ID

33459

Description

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Keywords

Versions (1)
  1. 12/10/18 12/10/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 10, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

English

Visit 4: Exclusion Criteria

1 forms  
Administrative data
Description

Administrative data

Date of Visit
Description

Date of Visit

Data type

date

Subject Number
Description

Subject Number

Data type

integer

Eligibility check
Description

Eligibility check

Did the subject meet all the entry criteria?
Description

Did the subject meet all the entry criteria?

Data type

boolean

If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
Description

Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria listed below

Data type

text

Exclusion Criteria
Description

Exclusion Criteria

For subjects receiving Plain PRP followed by DTPw-HBV Kft:
Description

tick "Yes" for any of the exclusion criteria that disqualified the subject from entry

Data type

text

Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.
Description

Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.

Data type

boolean

Chronic administration (more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
Description

For corticosteroids, this will mean prednisone, or equivalent >=0.5 mg/kg/day. Inhaled and topical steroids are allowed

Data type

boolean

Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
Description

Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.

Data type

boolean

Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.
Description

Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.

Data type

boolean

History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001
Description

History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001

Data type

boolean

Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease
Description

Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease

Data type

boolean

Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
Description

Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).

Data type

boolean

A family history of congenital or hereditary immunodeficiency.
Description

A family history of congenital or hereditary immunodeficiency.

Data type

boolean

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Description

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

Data type

boolean

Major congenital defects or serious chronic illness.
Description

Major congenital defects or serious chronic illness.

Data type

boolean

History of any neurologic disorders or seizures.
Description

Subject who only had a single, uncomplicated febrile convulsion in the past can be included

Data type

boolean

Acute disease at the time of enrollment.
Description

Acute disease - 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 t° <37.5°C/rectal t° <38°C

Data type

boolean

Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.
Description

Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.

Data type

boolean

Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Description

Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.

Data type

boolean

Specify other conditions.
Description

if necessary

Data type

text

Adverse events
Description

one of the following AE that constitute contraindications or precaution to further administration of DTP vaccine, having occurred after previous administration of DTP vaccine

Data type

text

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Similar models

Visit 4: Exclusion Criteria

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Eligibility check
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
Item
If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
text
Item Group
Exclusion Criteria
For subjects receiving Plain PRP followed by DTPw-HBV Kft:
Item
For subjects receiving Plain PRP followed by DTPw-HBV Kft:
text
Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.
Item
Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.
boolean
Chronic administration (more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
Item
Chronic administration (more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
boolean
Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
Item
Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
boolean
Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.
Item
Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.
boolean
History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001
Item
History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001
boolean
Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease
Item
Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease
boolean
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
boolean
A family history of congenital or hereditary immunodeficiency.
Item
A family history of congenital or hereditary immunodeficiency.
boolean
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
Major congenital defects or serious chronic illness.
Item
Major congenital defects or serious chronic illness.
boolean
History of any neurologic disorders or seizures.
Item
History of any neurologic disorders or seizures.
boolean
Acute disease at the time of enrollment.
Item
Acute disease at the time of enrollment.
boolean
Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.
Item
Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.
boolean
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Item
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
boolean
Specify other conditions.
Item
Specify other conditions.
text
Item
Adverse events
text
Adverse events
Code List
Adverse events
CL Item
Hypersensitivity to any component of the vaccine, or signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B and Hib vaccines (1)
CL Item
Encephalopathy (not due to another identifiable cause): acute, severe central nervous system disorder occurring within 7 days following vaccination->major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours (2)
CL Item
Axillary temperature of ≥ 40°C/rectal temperature ≥ 40.5°C within 48 hrs of vaccination (3)
CL Item
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hrs of vaccination (4)
CL Item
Persistent, inconsolable crying lasting ≥3 hrs, occurring within 48 hrs of vaccination (5)
CL Item
Convulsions with or without fever, occuring within 3 days of vaccination (6)
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