ID

33107

Description

Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

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Versions (1)
  1. 11/28/18 11/28/18 -
Copyright Holder

GSK group of companies

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November 28, 2018

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Creative Commons BY-NC 3.0
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Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021

English

Contraindications to Subsequent Vaccination

1 forms  
Absolute Contraindications
Description

Absolute Contraindications

The following adverse events constitute absolute contraindications to further administration of the DTPw study vaccines
Description

If any of these occur during the study, the subject must not receive additional doses of vaccine but may continue other study procedures at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE

Data type

text

DTPw vaccines
Description

DTPw vaccines

Check all that apply
Description

Check all that apply

Data type

text

GSK Biologicals' RotarixTM vaccine or its placebo
Description

GSK Biologicals' RotarixTM vaccine or its placebo

Check all that apply
Description

Check all that apply

Data type

text

Local registered OPV
Description

Local registered OPV

Check all that apply
Description

Check all that apply

Data type

text

Relative Contraindications
Description

Relative Contraindications

The following adverse events constitute absolute contraindications to further administration of the study vaccines at that point in time.
Description

If any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE.

Data type

text

DTPw vaccines
Description

DTPw vaccines

Check all that apply
Description

Check all that apply

Data type

text

GSK Biologicals' RotarixTM or its placebo
Description

GSK Biologicals' RotarixTM or its placebo

Check all that apply
Description

Check all that apply

Data type

text

Precautions for DTPw vaccines
Description

Precautions for DTPw vaccines

Check all that apply
Description

If any of the following events occur in temporal relation to receipt of the study vaccines, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered. The following event were previously considered contraindications and are now considered precautions by the Advisory Committee on Immunization Practices (ACIP)

Data type

text

DTPw-HBV vaccines should under no circumstances be administered intravenously
Description

DTPw-HBV vaccines should under no circumstances be administered intravenously

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Contraindications to Subsequent Vaccination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Absolute Contraindications
The following adverse events constitute absolute contraindications to further administration of the DTPw study vaccines
Item
The following adverse events constitute absolute contraindications to further administration of the DTPw study vaccines
text
Item Group
DTPw vaccines
Item
Check all that apply
text
Check all that apply
Code List
Check all that apply
CL Item
Anaphylactic reaction following the administration of vaccines (1)
CL Item
Known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or HB vaccines (2)
CL Item
Encephalopathy (not due to another identifiably cause): 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. Even though causation by DTP vaccine cannot be established, no subsequent doses of pertussis vaccine should be given. In these circumstances the vaccination course should be continued with DT and HB vaccines (3)
Item Group
GSK Biologicals' RotarixTM vaccine or its placebo
Item
Check all that apply
text
Check all that apply
Code List
Check all that apply
CL Item
Hypersensitivity reaction due to the vaccine (1)
CL Item
Intussusception (2)
Item Group
Local registered OPV
Item
Check all that apply
text
Check all that apply
Code List
Check all that apply
CL Item
Acute illness accompanied by fever (t°>=38.0°C) or systemic manifestations. Evidence of minor disease with t° rise <38.0°C (upper respiratory tract infections or diarrhea) is not considered contraindication, and the dose should be given later. (1)
CL Item
Immunodeficiency, neoplasms and hematologic malignancies. Immunization should be deferred for 12 months after the completion of immunosuppressive, hormonal, or radiation therapy. (2)
CL Item
Nervous system disorders associated with the previous poliomyelitis vaccine administration. (3)
Item Group
Relative Contraindications
The following adverse events constitute absolute contraindications to further administration of the study vaccines at that point in time.
Item
The following adverse events constitute absolute contraindications to further administration of the study vaccines at that point in time.
text
Item Group
DTPw vaccines
Item
Check all that apply
text
Check all that apply
Code List
Check all that apply
CL Item
Acute disease at the time of vaccioation: 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 (1)
CL Item
axillary t° >=37.5°C/rectal t° >= 38°C (2)
Item Group
GSK Biologicals' RotarixTM or its placebo
Item
Check all that apply
text
Check all that apply
Code List
Check all that apply
CL Item
Axillary t° >=37.5°C/ rectal t° >=38°C (1)
CL Item
Gastroenteritis within 7 days preceding the study vaccine administration (2)
Item Group
Precautions for DTPw vaccines
Item
Check all that apply
text
Check all that apply
Code List
Check all that apply
CL Item
Fever >=40°C (axillary temperature) within 48 hours of vaccination not due to another identifiably cause (1)
CL Item
Collapse or shock-like state (hypotonic-hyposensitive episode) within 48 hours of vaccination (2)
CL Item
Persistent, inconsolable crying lasting >=3 hours occuring within 48 hours of vaccination (3)
CL Item
Seizures with or without fever occurring within 3 days of vaccination (4)
Item Group
DTPw-HBV vaccines should under no circumstances be administered intravenously
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