Status:
COMPLETED
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
Lead Sponsor:
Novartis Vaccines
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Meningococcal Meningitis
Eligibility:
All Genders
11-18 years
Phase:
PHASE3
Brief Summary
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commerc...
Eligibility Criteria
Inclusion
- Subjects enrolled in V59P13:
- healthy subjects who have completed the V59P13 study.
- Naïve subjects:
- healthy subjects aged-matched with subjects who had completed the V59P13 trial.(currently 16-23 years old).
Exclusion
- Subjects who had completed the V59P13 study:
- who received any meningococcal vaccine after the V59P13 trial;
- who have had previous confirmed or suspected disease caused by N. meningitidis;
- who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
- subjects with any serious, acute or chronic progressive disease.
- Naïve subjects:
- who previously received any meningococcal vaccine;
- who have had previous confirmed or suspected disease caused by N. meningitidis;
- who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
- subjects with any serious, acute or chronic progressive disease.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT00856297
Start Date
February 1 2009
End Date
November 1 2012
Last Update
June 14 2017
Active Locations (32)
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1
37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615
Birmingham, Alabama, United States, 35205
2
6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway
Fremont, California, United States, 94538
3
7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor
Fresno, California, United States, 93726
4
8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB
Hayward, California, United States, 94545