Status:
COMPLETED
Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Haemophilus Influenzae Type b
Neisseria Meningitidis
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief Summary
The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine ...
Detailed Description
This multicenter study is open and has 2 treatment groups with Hiberix™ + a commercially available MenC vaccine as active controls. Priorix™ is given concomitantly in both groups. In the primary phase...
Eligibility Criteria
Inclusion
- Primary phase:
- Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 18 months of age at the time of vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents'/guardians knowledge.
- Having completed primary vaccination with two doses of Haemophilus influenzae type b outer membrane protein (Hib-OMP) containing vaccine OR three doses of diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b (DTPa/Hib) containing vaccine at least 6 months before the study start.
- Long-term persistence phase:
- \- Having participated in the vaccination study 106445
Exclusion
- For the primary vaccination phase:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination.
- Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before vaccination and ending 30 days after vaccination.
- Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose.
- Previous administration of a booster dose of Hib vaccine.
- Previous vaccination against measles, mumps, rubella.
- History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases.
- Known exposure to measles, mumps or rubella within 30 days prior to the start of the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of neurological disorders or more than one episode of febrile convulsion.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Additional exclusion criteria for the long-term persistence phase: to be checked each year.
- Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines.
- History of H. influenzae type b, meningococcal serogroup C diseases.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2007
Estimated Enrollment :
433 Patients enrolled
Trial Details
Trial ID
NCT00326118
Start Date
June 1 2006
End Date
November 6 2007
Last Update
August 24 2018
Active Locations (7)
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1
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
2
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
3
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
4
GSK Investigational Site
Herston, Queensland, Australia, 4029