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