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 (2) ▾
  1. 3/25/19
  2. 12/31/19
Copyright Holder:
GSK group of companies
Uploaded on:

December 31, 2019

DOI:
No DOI assigned. To request one please log in.
License:
Creative Commons BY-NC 3.0
Model comments:

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for:

Item comments for:

In order to download data models you must be logged in. Please log in or register for free.

Hib-MenAC vaccine administered intramuscularly in infants at 6 10 and 14 weeks of age - 104430

Visit 5 ( Month 7.5)

  1. StudyEvent: ODM
    1. Visit 5 ( Month 7.5)
Administrative data
ELIMINATION CRITERIA DURING THE STUDY
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period.
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.
Administration of a meningococcal vaccine not foreseen by the study protocol during the entire study period.
Administration of immunoglobulins and/or any blood products during the study period.
Contraindications and precautions for further doses
Anaphylactic reaction following the administration of vaccine(s).
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.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
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).
Axillary or oral temperature ≥ 37.5°C/rectal temperature ≥ 38°C at the time of vaccination.
DEMOGRAPHICS
Gender
Race
Has the subject had any serious adverse event since the end of the primary phase and before the start of this booster vaccination ?
PRE-VACCINATION ASSESSMENT
°C
Route
THROAT SWAB (for subject’s parents/guardians)
Will the throat swab be taken from the same person as at Visit 1, 2 or 4?
I certify that Informed Consent has been obtained prior to any study procedure :
Has a throat swab been taken ?
THROAT SWAB (for subject)
Has a throat swab been taken ?
VACCINE ADMINISTRATION
Has the commercial measles vaccine been administered ?
Has the commercial yellow fever vaccine been administered ?