Status:
COMPLETED
Safety, Reactogenicity & Immunogenicity Study to Evaluate a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™ in Toddlers (13-14 m) Primed With 3 Doses of Hib and MenC-CRM197
Lead Sponsor:
GlaxoSmithKline
Conditions:
Haemophilus Influenzae Type b
Neisseria Meningitidis
Eligibility:
All Genders
13-14 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles, mumps and rubella...
Detailed Description
This multicenter study is open with respect to the treatment allocation, but double-blind with respect to the Hib-MenC-TT lots (3 lots). Hib-MenC-TT and Priorix™, when given separately, serve as activ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy male or female between, and including, 13 and 14 months of age.
- Previously completed 3-dose primary vaccination with a MenC-CRM197 vaccine, and Hib (given as part of a combined DTPa-containing vaccine) with at least 6 months between the administration of the third doses and the study entry.
- Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the study vaccine, or planned use during the study period.
- Previous vaccination against OR history of H. influenzae type b (Hib) and/or meningococcal serogroup C disease and/or measles, mumps or rubella OR known exposure to measles, mumps or rubella within 30 days prior to the start of the present study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of any neurologic disorders or seizures.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including neomycine
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT00263653
Start Date
March 1 2005
End Date
September 1 2005
Last Update
September 21 2016
Active Locations (16)
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1
GSK Investigational Site
Almería, Spain, 04007
2
GSK Investigational Site
Almería, Spain, 04009
3
GSK Investigational Site
Antequera/Málaga, Spain, 29200
4
GSK Investigational Site
Aravaca, Spain, 28023