ID
35819
Descrizione
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
Keywords
versioni (3)
- 25/03/19 25/03/19 -
- 31/12/19 31/12/19 -
- 15/03/21 15/03/21 - Dr. rer. medic Philipp Neuhaus
Titolare del copyright
GSK group of companies
Caricato su
25 marzo 2019
DOI
Per favore, per richiedere un accesso.
Licenza
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
Descrizione
ELIMINATION CRITERIA DURING THE STUDY
Descrizione
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 di dati
text
Descrizione
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
Tipo di dati
boolean
Descrizione
(For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Tipo di dati
boolean
Descrizione
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 di dati
boolean
Descrizione
Administration of a meningococcal vaccine not foreseen by the study protocol during the entire study period.
Tipo di dati
boolean
Descrizione
Administration of immunoglobulins and/or any blood products during the study period.
Tipo di dati
boolean
Descrizione
Contraindications and precautions for further doses
Descrizione
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 di dati
text
Descrizione
Anaphylactic reaction following the administration of vaccine(s).
Tipo di dati
boolean
Descrizione
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 di dati
boolean
Descrizione
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Tipo di dati
boolean
Descrizione
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 di dati
boolean
Descrizione
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 di dati
boolean
Descrizione
DEMOGRAPHICS
Descrizione
Previous study : 759346/009 (DTPwHB/HIBMenACTT009)
Tipo di dati
integer
Descrizione
Birth date
Tipo di dati
date
Descrizione
Gender
Tipo di dati
text
Descrizione
Race
Tipo di dati
text
Descrizione
Specify Other
Tipo di dati
text
Descrizione
If Yes → Specify number of SAE’s : |__|__| and → Check SAE form(s) have been submitted to GSK Biologicals
Tipo di dati
boolean
Descrizione
PRE-VACCINATION ASSESSMENT
Descrizione
THROAT SWAB (for subject’s parents/guardians)
Descrizione
Will the throat swab be taken from the same person as at Visit 1, 2 or 4 ?
Tipo di dati
boolean
Descrizione
Informed Consent
Tipo di dati
boolean
Descrizione
Informed Consent Date
Tipo di dati
date
Descrizione
Has a throat swab been taken ?
Tipo di dati
boolean
Descrizione
Date
Tipo di dati
date
Descrizione
THROAT SWAB (for subject)
Descrizione
VACCINE ADMINISTRATION
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Visit 5 ( Month 7.5)
- StudyEvent: ODM