ID

33105

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-11-28 2018-11-28 -
Rättsinnehavare

GSK group of companies

Uppladdad den

28 november 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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

Engelsk

Elimination Criteria (Study Eligibility)

1 Formulär  
Elimination Criteria during the Study
Beskrivning

Elimination Criteria during the Study

Check below "Yes" for all that apply
Beskrivning

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

Datatyp

text

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

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

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

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.

Datatyp

boolean

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

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

Datatyp

boolean

Tillbaka till toppen

Similar models

Elimination Criteria (Study Eligibility)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial