ID

33105

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

Keywords

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

GSK group of companies

Uploaded on

November 28, 2018

DOI

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License

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

Elimination Criteria (Study Eligibility)

1 forms  
Elimination Criteria during the Study
Description

Elimination Criteria during the Study

Check below "Yes" for all that apply
Description

The following criteria should be checked at each visit subsequent to the first visit. If any become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol analysis

Data type

text

A. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Description

A. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.

Data type

boolean

B. Chronic administration (more than 14 days) of immunosuppressants or other immunomodifying drugs during the study period.
Description

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

Data type

boolean

C. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.
Description

C. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.

Data type

boolean

D. Administration of immunoglobulins and/or any blood products during the study period.
Description

D. Administration of immunoglobulins and/or any blood products during the study period.

Data type

boolean

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Similar models

Elimination Criteria (Study Eligibility)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Elimination Criteria during the Study
Check below "Yes" for all that apply
Item
Check below "Yes" for all that apply
text
A. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Item
A. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
B. Chronic administration (more than 14 days) of immunosuppressants or other immunomodifying drugs during the study period.
Item
B. Chronic administration (more than 14 days) of immunosuppressants or other immunomodifying drugs during the study period.
boolean
C. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.
Item
C. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.
boolean
D. Administration of immunoglobulins and/or any blood products during the study period.
Item
D. Administration of immunoglobulins and/or any blood products during the study period.
boolean
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