Status:
COMPLETED
Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neisseria Meningitidis
Haemophilus Influenzae Type b
Eligibility:
All Genders
13-14 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were ...
Detailed Description
The study is open and Infanrix hexa will serve as active control. Subjects will receive one vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before and one month ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy male or female between, and including, 13 and 14 months of age
- Having participated in the primary vaccination study 217744/097.
- Exclusion criteria:
- Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT00323050
Start Date
November 1 2004
End Date
March 1 2005
Last Update
September 16 2016
Active Locations (16)
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1
GSK Investigational Site
Alcorcón, Spain, 28922
2
GSK Investigational Site
Almeira, Spain, 4009
3
GSK Investigational Site
Barcelona, Spain, 08025
4
GSK Investigational Site
Barcelona, Spain, 08950