Status:
COMPLETED
Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
Lead Sponsor:
Novartis Vaccines
Conditions:
Meningococcal Meningitis
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
Brief Summary
The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percen...
Eligibility Criteria
Inclusion
- infants 6 to 8 months old inclusive, who were born after full term pregnancy and previously received three doses of both Prevenar and Infanrix-hexa vaccines at least 30 days before study entry
Exclusion
- who previously received any meningococcal vaccine;
- who have had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;
- who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
- Subjects with any serious, acute or chronic progressive disease
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
662 Patients enrolled
Trial Details
Trial ID
NCT00667602
Start Date
March 1 2008
End Date
October 1 2010
Last Update
November 7 2013
Active Locations (28)
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1
Site 22
Bad Kreuznach, Germany, 55543
2
Site 38
Bad Lobenstein, Germany, 07356
3
Site 24
Balve, Germany, 58802
4
Site 3
Berlin, Germany, 12589