Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine

Completed · Phase 3

Conditions studied: Meningococcal Meningitis

In brief

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 commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

Key facts

Study ID

NCT00856297

Run by

Novartis Vaccines

People needed

389

Starts

2009-02-01

Expected to finish

2012-11-01

Last updated by the study team

2017-06-14

Who can join

Age: 11 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615 — Birmingham, Alabama, United States
• 6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway — Fremont, California, United States
• 7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor — Fresno, California, United States
• 8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB — Hayward, California, United States
• Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor — Oakland, California, United States
• 9 Kaiser Permanente Roseville 1840 Sierra Gardens Drive, Vaccine Studies — Roseville, California, United States
• 11 Kaiser Permanente Sacramento 6600 Bruceville Rd., Pediatric Station C — Sacramento, California, United States
• Kaiser Permanente, 6600 Bruceville Rd. — Sacramento, California, United States
• 10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1 — San Jose, California, United States
• 2 PAMPA 2155 Post Oak Tritt Road, Suite 100 — Marietta, Georgia, United States
• 3 PAMPA 120 Stonebridge Parkway Ste. 410 — Woodstock, Georgia, United States
• 53 Pediatric/Adult Research Inc. 201 South Fifth Street, Suite 102 — Bardstown, Kentucky, United States
• 38 Akron Children's Hospital One Perkins Square — Akron, Ohio, United States
• 43 Dr. Senders and Associates 2054 South Green Road — South Euclid, Ohio, United States
• 19 Children's Health Care West 4671 West Lake Road — Erie, Pennsylvania, United States
• 21 Greenville Medical Centre Inc 90 Shenango Street — Greenville, Pennsylvania, United States
• 24 (seen at site 21) Family Healthcare Partners 420 Hillcrest Avenue — Grove City, Pennsylvania, United States
• 23 Pediatric Associates of Latrobe 210 Weldon Street — Latrobe, Pennsylvania, United States
• 14 Squirrel Hill Office 4070 Beechwood Blvd — Pittsburgh, Pennsylvania, United States
• 16 Pediatric Alliance Greentree Division 969 Greentree Road Suite 100 — Pittsburgh, Pennsylvania, United States
• 15 South Hills Pediatrics 4411 Stilley Road — Pittsburgh, Pennsylvania, United States
• 13 Pediatric Alliance Southwestern 850 Clairton Blvd. — Pittsburgh, Pennsylvania, United States
• 20 Pediatric Alliance Arcadia Division 9000 Perry Highway Suite 120 — Pittsburgh, Pennsylvania, United States
• 12 & 18 Primary Physicians Research, Inc. 1580 McLaughlin Run Road — Pittsburgh, Pennsylvania, United States
• Admin Primary Physicians Research, Inc. 1580 McLaughlin Run Road — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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