ID
35819
Descripción
Study ID: 104430 Clinical Study ID: 104430 Study Title: A phase II, double blind, randomized, controlled study to evaluate the immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Hib-MenAC vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, as compared to GSK Biologicals’ Hiberix vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, when administered intramuscularly in infants at 6, 10 and 14 weeks of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1/2 Study Recruitment Status: Completed Generic Name: Hib-MenAC vaccine Trade Name: Tritanrix-HepB, Hiberix Study Indication: Immune, Inflammatory & Infections - Other
Palabras clave
Versiones (3)
- 25/3/19 25/3/19 -
- 31/12/19 31/12/19 -
- 15/3/21 15/3/21 - Dr. rer. medic Philipp Neuhaus
Titular de derechos de autor
GSK group of companies
Subido en
25 de marzo de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Hib-MenAC vaccine administered intramuscularly in infants at 6, 10 and 14 weeks of age - 104430
Visit 5 ( Month 7.5)
- StudyEvent: ODM
Descripción
ELIMINATION CRITERIA DURING THE STUDY
Descripción
If any become applicable during the study, it will not require withdrawal of the subject from the study but does determine a subject’s evaluability in the according-to-protocol (ATP) analysis
Tipo de datos
text
Descripción
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) 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
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose of vaccine(s) with the exception of OPV.
Tipo de datos
boolean
Descripción
Administration of a meningococcal vaccine not foreseen by the study protocol during the entire study period.
Tipo de datos
boolean
Descripción
Administration of immunoglobulins and/or any blood products during the study period.
Tipo de datos
boolean
Descripción
Contraindications and precautions for further doses
Descripción
if any of these AEs 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
Tipo de datos
text
Descripción
Anaphylactic reaction following the administration of vaccine(s).
Tipo de datos
boolean
Descripción
Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, HB, Hib or meningococcal vaccines.
Tipo de datos
boolean
Descripción
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Tipo de datos
boolean
Descripción
The following AEs constitute contraindications to administration of the study vaccines at that point in time; 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 adverse event
Tipo de datos
boolean
Descripción
The following AEs constitute contraindications to administration of the study vaccines at that point in time; 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 adverse event
Tipo de datos
boolean
Descripción
DEMOGRAPHICS
Descripción
Previous study : 759346/009 (DTPwHB/HIBMenACTT009)
Tipo de datos
integer
Descripción
Birth date
Tipo de datos
date
Descripción
Gender
Tipo de datos
text
Descripción
Race
Tipo de datos
text
Descripción
Specify Other
Tipo de datos
text
Descripción
If Yes → Specify number of SAE’s : |__|__| and → Check SAE form(s) have been submitted to GSK Biologicals
Tipo de datos
boolean
Descripción
PRE-VACCINATION ASSESSMENT
Descripción
THROAT SWAB (for subject’s parents/guardians)
Descripción
Will the throat swab be taken from the same person as at Visit 1, 2 or 4 ?
Tipo de datos
boolean
Descripción
Informed Consent
Tipo de datos
boolean
Descripción
Informed Consent Date
Tipo de datos
date
Descripción
Has a throat swab been taken ?
Tipo de datos
boolean
Descripción
Date
Tipo de datos
date
Descripción
THROAT SWAB (for subject)
Descripción
VACCINE ADMINISTRATION
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Visit 5 ( Month 7.5)
- StudyEvent: ODM