ID
33110
Descripción
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
Palabras clave
Versiones (1)
- 28/11/18 28/11/18 -
Titular de derechos de autor
GSK group of companies
Subido en
28 de noviembre de 2018
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Visit 1: Eligibility Form
- StudyEvent: ODM
Descripción
Eligibility check
Descripción
Inclusion Criteria
Descripción
Tick "No" for any inclusion criteria subject failed
Tipo de datos
text
Descripción
1.Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
Tipo de datos
boolean
Descripción
2.Administration of one dose of hepatitis B vaccine at birth (within 72 hours after birth)
Tipo de datos
boolean
Descripción
3.A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
Tipo de datos
boolean
Descripción
4.Written informed consent obtained from parent or guardian of the subject.
Tipo de datos
boolean
Descripción
5.Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Tipo de datos
boolean
Descripción
6.Born after a normal gestation period (36 to 42 weeks).
Tipo de datos
boolean
Descripción
Exclusion Criteria
Descripción
Tick "Yes" for any of the exclusion criteria that disqualified the subject from entry
Tipo de datos
text
Descripción
7.Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Tipo de datos
boolean
Descripción
For corticosteroids, this will mean prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids are allowed.
Tipo de datos
boolean
Descripción
9.Planned administration/Administration of vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exeption of oral polio vaccine (OPV).
Tipo de datos
boolean
Descripción
10.Bacille-Calmette-Guérin (BCG) vaccine received after the first 6 weeks of life.
Tipo de datos
boolean
Descripción
11. Previous vaccination against diphtheria, tetanus, and/or pertussis.
Tipo de datos
boolean
Descripción
12.History of diphtheris, tetanus, pertussis and/or hepatitis B disease.
Tipo de datos
boolean
Descripción
13.Known exposure to diphtheria, tetanus, pertussis and/or hepatitis B disease since birth.
Tipo de datos
boolean
Descripción
warrants deferral of the vacination
Tipo de datos
boolean
Descripción
15.Any confirmed or suspected immunosuppresive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
Tipo de datos
boolean
Descripción
16.A family history of congenital or hereditary immunodeficiency.
Tipo de datos
boolean
Descripción
17.History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Tipo de datos
boolean
Descripción
18.Major congenital defects or serious chronic illness.
Tipo de datos
boolean
Descripción
19.History of any neurologic disorders or seizures
Tipo de datos
boolean
Descripción
defined as 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.r. axillary temperature <37.5°C/rectal temperature <38°C
Tipo de datos
boolean
Descripción
21.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Tipo de datos
boolean
Descripción
22.Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Tipo de datos
boolean
Descripción
Randomisation/Treatment allocation
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Visit 1: Eligibility Form
- StudyEvent: ODM