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Information:
Fel:
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
Similar models
Visit 5 ( Month 7.5)
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Center
Item
Center
integer
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
The following criteria should be checked at each visit subsequent to the first visit.
Item
The following criteria should be checked at each visit subsequent to the first visit.
text
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
boolean
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period.
boolean
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.
Item
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.
boolean
Administration of a meningococcal vaccine not foreseen by the study protocol during the entire study period.
Item
Administration of a meningococcal vaccine not foreseen by the study protocol during the entire study period.
boolean
Administration of immunoglobulins and/or any blood products during the study period.
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
Item Group
Contraindications and precautions for further doses
The following adverse events (AEs) constitute absolute contraindications to further administration of the study vaccines
Item
The following adverse events (AEs) constitute absolute contraindications to further administration of the study vaccines
text
Anaphylactic reaction following the administration of vaccine(s).
Item
Anaphylactic reaction following the administration of vaccine(s).
boolean
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.
Item
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.
boolean
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary or oral temperature < 37.5°C/rectal temperature < 38°C).
Item
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary or oral temperature < 37.5°C/rectal temperature < 38°C).
boolean
Axillary or oral temperature ≥ 37.5°C/rectal temperature ≥ 38°C at the time of vaccination.
Item
Axillary or oral temperature ≥ 37.5°C/rectal temperature ≥ 38°C at the time of vaccination.
boolean
Subject number
Item
Subject number
integer
Birth date
Item
Date of birth
date
CL Item
Male (1)
CL Item
Female (2)
CL Item
Black (1)
CL Item
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
CL Item
Other (6)
Specify Other
Item
If Other, please specify
text
Has the subject had any serious adverse event since the end of the primary phase and before the start of this booster vaccination ?
Item
Has the subject had any serious adverse event since the end of the primary phase and before the start of this booster vaccination ?
boolean
Temperature
Item
Temperature
float
CL Item
Axillary (1)
CL Item
Rectal (2)
Item Group
THROAT SWAB (for subject’s parents/guardians)
Will the throat swab be taken from the same person as at Visit 1, 2 or 4 ?
Item
Will the throat swab be taken from the same person as at Visit 1, 2 or 4 ?
boolean
Informed Consent
Item
I certify that Informed Consent has been obtained prior to any study procedure :
boolean
Informed Consent Date
Item
Informed Consent Date:
date
Has a throat swab been taken ?
Item
Has a throat swab been taken ?
boolean
Date
Item
Please complete only if different from visit date:
date
throat swab
Item
Has a throat swab been taken ?
boolean
Please complete only if different from visit date
Item
Please complete only if different from visit date:
date
measles vaccine
Item
Has the commercial measles vaccine been administered ?
boolean
yellow fever vaccine
Item
Has the commercial yellow fever vaccine been administered ?
boolean