Status:
COMPLETED
Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants
Lead Sponsor:
Novartis Vaccines
Conditions:
Meningococcal Disease
Eligibility:
All Genders
6-8 years
Phase:
PHASE2
Brief Summary
To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.
Eligibility Criteria
Inclusion
- healthy 6-8 months old infants
Exclusion
- previous receipt of any meningococcal B vaccine;
- previous ascertained or suspected disease caused by N meningitidis;
- history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
- any present or suspected serious acute or chronic disease
- known or suspected autoimmune disease or impairment /alteration of immune function
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00433914
Start Date
February 1 2007
End Date
July 1 2008
Last Update
March 6 2015
Active Locations (1)
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1
Oxford, United Kingdom, OX3 7LJ