ID
35819
Beschreibung
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
Stichworte
Versionen (3)
- 25.03.19 25.03.19 -
- 31.12.19 31.12.19 -
- 15.03.21 15.03.21 - Dr. rer. medic Philipp Neuhaus
Rechteinhaber
GSK group of companies
Hochgeladen am
25. März 2019
DOI
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Lizenz
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
Beschreibung
ELIMINATION CRITERIA DURING THE STUDY
Beschreibung
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
Datentyp
text
Beschreibung
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
Datentyp
boolean
Beschreibung
(For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Datentyp
boolean
Beschreibung
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.
Datentyp
boolean
Beschreibung
Administration of a meningococcal vaccine not foreseen by the study protocol during the entire study period.
Datentyp
boolean
Beschreibung
Administration of immunoglobulins and/or any blood products during the study period.
Datentyp
boolean
Beschreibung
Contraindications and precautions for further doses
Beschreibung
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
Datentyp
text
Beschreibung
Anaphylactic reaction following the administration of vaccine(s).
Datentyp
boolean
Beschreibung
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.
Datentyp
boolean
Beschreibung
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Datentyp
boolean
Beschreibung
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
Datentyp
boolean
Beschreibung
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
Datentyp
boolean
Beschreibung
DEMOGRAPHICS
Beschreibung
Previous study : 759346/009 (DTPwHB/HIBMenACTT009)
Datentyp
integer
Beschreibung
Birth date
Datentyp
date
Beschreibung
Gender
Datentyp
text
Beschreibung
Race
Datentyp
text
Beschreibung
Specify Other
Datentyp
text
Beschreibung
If Yes → Specify number of SAE’s : |__|__| and → Check SAE form(s) have been submitted to GSK Biologicals
Datentyp
boolean
Beschreibung
PRE-VACCINATION ASSESSMENT
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THROAT SWAB (for subject’s parents/guardians)
Beschreibung
Will the throat swab be taken from the same person as at Visit 1, 2 or 4 ?
Datentyp
boolean
Beschreibung
Informed Consent
Datentyp
boolean
Beschreibung
Informed Consent Date
Datentyp
date
Beschreibung
Has a throat swab been taken ?
Datentyp
boolean
Beschreibung
Date
Datentyp
date
Beschreibung
THROAT SWAB (for subject)
Beschreibung
VACCINE ADMINISTRATION
Ähnliche Modelle
Visit 5 ( Month 7.5)
- StudyEvent: ODM