ID
35819
Beschrijving
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
Trefwoorden
Versies (3)
- 25-03-19 25-03-19 -
- 31-12-19 31-12-19 -
- 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
Houder van rechten
GSK group of companies
Geüploaded op
25 maart 2019
DOI
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Licentie
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
Beschrijving
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
Datatype
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.
Datatype
boolean
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(For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Datatype
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.
Datatype
boolean
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Administration of a meningococcal vaccine not foreseen by the study protocol during the entire study period.
Datatype
boolean
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Administration of immunoglobulins and/or any blood products during the study period.
Datatype
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
Datatype
text
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Anaphylactic reaction following the administration of vaccine(s).
Datatype
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.
Datatype
boolean
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Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Datatype
boolean
Beschrijving
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
Datatype
boolean
Beschrijving
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
Datatype
boolean
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DEMOGRAPHICS
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Previous study : 759346/009 (DTPwHB/HIBMenACTT009)
Datatype
integer
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Birth date
Datatype
date
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Gender
Datatype
text
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Race
Datatype
text
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Specify Other
Datatype
text
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If Yes → Specify number of SAE’s : |__|__| and → Check SAE form(s) have been submitted to GSK Biologicals
Datatype
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 ?
Datatype
boolean
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Informed Consent
Datatype
boolean
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Informed Consent Date
Datatype
date
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Has a throat swab been taken ?
Datatype
boolean
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Date
Datatype
date
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THROAT SWAB (for subject)
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VACCINE ADMINISTRATION
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Visit 5 ( Month 7.5)
- StudyEvent: ODM