Status:
COMPLETED
3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age
Lead Sponsor:
GlaxoSmithKline
Conditions:
Haemophilus Influenzae Type b
Neisseria Meningitidis
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serog...
Detailed Description
Primary \& booster vaccination study to evaluate the immuno,reacto \& safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C \& Y-conjugate vaccine \...
Eligibility Criteria
Inclusion
- Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth.
Exclusion
- Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2003
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT00129116
Start Date
March 1 2003
End Date
December 16 2003
Last Update
August 27 2018
Active Locations (26)
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1
GSK Investigational Site
Asse, Belgium, 1730
2
GSK Investigational Site
Drongen, Belgium, 9031
3
GSK Investigational Site
Ghent, Belgium, 9000
4
GSK Investigational Site
Maldegem, Belgium, 9990