Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine

Completed · Phase 3

Conditions studied: Meningococcal Meningitis

In brief

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 Conjugate Vaccine. The study also enrolled age-matched subjects who have never received any meningococcal vaccine (naïve subjects) to serve as a control group. In addition, the response of a booster dose at 60 months was evaluated.

Key facts

Study ID

NCT01148017

Run by

Novartis Vaccines

People needed

433

Starts

2010-07-01

Expected to finish

2013-04-01

Last updated by the study team

2017-08-14

Who can join

Age: 3 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615 — Birmingham, Alabama, United States
• Premier Health Research 9317 Firestone Blvd. — Downey, California, United States
• Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624 — Oakland, California, United States
• Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308 — Paramount, California, United States
• Center for Clinical Trials, LLC 16660 Paramount Blvd., Suite 301 — Paramount, California, United States
• Kaiser Permanente Pleasanton 7601 Stoneridge Drive, Second Floor — Pleasanton, California, United States
• Kaiser Permanente San Francisco 2200 O'Farrell St., Sixth Floor — San Francisco, California, United States
• Kaiser Permanente Santa Clara 710 Lawrence Expressway, Pediatric Clinic Department — Santa Clara, California, United States
• Children's Memorial Hospital 2300 Children's Plaza, Box 155 — Chicago, Illinois, United States
• Kentucky Pediatric/Adult Research 201 South Fifth Street, Suite 102 — Bardstown, Kentucky, United States
• 28 Annapolis Pediatrics, 200 Forbes Street, Suite 200 — Annapolis, Maryland, United States
• Senders Pediatrics 2054 South Green Road — Cleveland, Ohio, United States
• Pediatric Medical Associates 160 West Germantown Pike Suite D2 — East Norriton, Pennsylvania, United States
• Children's Health Care 2501 West 12th Street — Erie, Pennsylvania, United States
• Pennridge Pediatric Associates 270 Main Street — Harleysville, Pennsylvania, United States
• Kid's Way Pediatrics 3068 Innovation Way — Hermitage, Pennsylvania, United States
• Pediatric Medical Associates 1077 Rydal Road Suite 300 — Rydal, Pennsylvania, United States
• Pennridge Pediatric Associates 711 Lawn Avenue — Sellersville, Pennsylvania, United States
• PEAK Research 2859 Washington Rd., Ste. 412B — Upper Saint Clair, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.