Status:
COMPLETED
Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
Lead Sponsor:
Novartis Vaccines
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Meningococcal Meningitis
Eligibility:
All Genders
37-63 years
Phase:
PHASE3
Brief Summary
The primary objective was to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received Novartis MenACWY...
Eligibility Criteria
Inclusion
- Children eligible to be enrolled in the study are those whose parents provide written informed consent, and are in generally good health based on the clinical judgment of the investigators.
- Group 1 and 2 (Follow up) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study (NCT00474526).
- Group 3 and 4 (Naïve) subjects must be healthy, meningococcal vaccine-naïve children ages 40 +/- 3 months (Group 3) or 60 +/-3 months (Group 4) at the time of enrollment, respectively.
Exclusion
- Serious, acute, or chronic illnesses are reasons for exclusion.
- Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines (including FluMist®) are excluded for the 14 days prior to the enrollment visit.
- Subjects who have received any meningococcal vaccine since birth (Groups 3 \& 4 -naive) or last study dose in V59P14 (NCT00474526) trial (Groups 1 \& 2 - follow on).
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
433 Patients enrolled
Trial Details
Trial ID
NCT01148017
Start Date
July 1 2010
End Date
April 1 2013
Last Update
August 14 2017
Active Locations (19)
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1
Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
Birmingham, Alabama, United States, 35205
2
Premier Health Research 9317 Firestone Blvd.
Downey, California, United States, 90241
3
Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624
Oakland, California, United States, 94611
4
Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308
Paramount, California, United States, 90723