ID
33107
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)
- 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.
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
Contraindications to Subsequent Vaccination
- StudyEvent: ODM
Beskrivning
DTPw vaccines
Beskrivning
GSK Biologicals' RotarixTM vaccine or its placebo
Beskrivning
Local registered OPV
Beskrivning
Relative Contraindications
Beskrivning
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for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator.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.
Datatyp
text
Beskrivning
DTPw vaccines
Beskrivning
GSK Biologicals' RotarixTM or its placebo
Beskrivning
Precautions for DTPw vaccines
Beskrivning
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)
Datatyp
text
Beskrivning
DTPw-HBV vaccines should under no circumstances be administered intravenously
Similar models
Contraindications to Subsequent Vaccination
- StudyEvent: ODM