Status:
COMPLETED
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
Lead Sponsor:
Novartis Vaccines
Conditions:
Meningococcal Infections
Eligibility:
All Genders
2-10 years
Phase:
PHASE3
Brief Summary
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
Eligibility Criteria
Inclusion
- healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
- who are available for all visits and telephone calls scheduled for the study
- who are up-to-date with age-appropriate routine childhood vaccinations
Exclusion
- whose parent or legal guardian is unwilling or unable to give written informed consent
- who had a previous or suspected disease caused by N. meningitidis;
- who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- who have received any investigational agents or vaccines within 90 days prior to enrollment
- who have any serious acute, chronic or progressive disease
- who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
- who have a history of anaphylaxis, serious vaccine reactions
- who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
- who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
- who have Down's syndrome or other known cytogenic disorders
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
2907 Patients enrolled
Trial Details
Trial ID
NCT00616421
Start Date
March 1 2008
End Date
October 1 2009
Last Update
February 15 2016
Active Locations (68)
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1
Children's Investigational Reserach Program
Bentonville, Arkansas, United States, 72712
2
Arkansas Pediatric Research Group
Little Rock, Arkansas, United States, 72205
3
Premier Health Research Center
Downey, California, United States, 90241
4
Kaiser Permanente - Fremont
Fremont, California, United States, 94538