ID
35819
Beskrivning
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
Nyckelord
Versioner (3)
- 2019-03-25 2019-03-25 -
- 2019-12-31 2019-12-31 -
- 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
Rättsinnehavare
GSK group of companies
Uppladdad den
25 mars 2019
DOI
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Licens
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
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ELIMINATION CRITERIA DURING THE STUDY
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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
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text
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Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
Datatyp
boolean
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(For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Datatyp
boolean
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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.
Datatyp
boolean
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Administration of a meningococcal vaccine not foreseen by the study protocol during the entire study period.
Datatyp
boolean
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Administration of immunoglobulins and/or any blood products during the study period.
Datatyp
boolean
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Contraindications and precautions for further doses
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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
Datatyp
text
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Anaphylactic reaction following the administration of vaccine(s).
Datatyp
boolean
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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.
Datatyp
boolean
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Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Datatyp
boolean
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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
Datatyp
boolean
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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
Datatyp
boolean
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DEMOGRAPHICS
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Previous study : 759346/009 (DTPwHB/HIBMenACTT009)
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integer
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Birth date
Datatyp
date
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Gender
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text
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Race
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text
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Specify Other
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text
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If Yes → Specify number of SAE’s : |__|__| and → Check SAE form(s) have been submitted to GSK Biologicals
Datatyp
boolean
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PRE-VACCINATION ASSESSMENT
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THROAT SWAB (for subject’s parents/guardians)
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Will the throat swab be taken from the same person as at Visit 1, 2 or 4 ?
Datatyp
boolean
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Informed Consent
Datatyp
boolean
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Informed Consent Date
Datatyp
date
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Has a throat swab been taken ?
Datatyp
boolean
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Date
Datatyp
date
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THROAT SWAB (for subject)
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VACCINE ADMINISTRATION
Similar models
Visit 5 ( Month 7.5)
- StudyEvent: ODM