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

This study is currently recruiting participants.
Verified December 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01148017
First received: June 16, 2010
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

The primary objective is to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 study who received Novartis MenACWY Conjugate Vaccine. The study will also enroll 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 the 60 months will be evaluated.


Condition Intervention Phase
Meningococcal Meningitis
Biological: Meningococcal ACWY conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 40 months of age persistence of bactericidal antibodies antibody response in children who previously received at least one dose of MenACWY [ Time Frame: 40 months of age ] [ Designated as safety issue: No ]
  • 60 months of age persistence of bactericidal antibodies antibody response in children who previously received at least one dose of MenACWY [ Time Frame: 60 months of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the antibody response and safety and tolerability of one MenACWY dose administered at 60 months of age [ Time Frame: 60 months of age (perisistance) and 28 days post vaccination at 60 months of age (bost analysis) ] [ Designated as safety issue: No ]

Estimated Enrollment: 409
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Subjects who previously received the Novartis MenACWY vaccine with a 2,4,6,12 or 2,4,6,13 months of age schedule in V59P14 trial. Blood draw at 40 and 60 months of age, MenACWY injection at 60 months of age and a blood draw 28 days after the injection.
Biological: Meningococcal ACWY conjugate vaccine
Detailed safety will be collected for 7 days post injection and medically attended Adverse Events and SAEs for 28 days post injection.
Experimental: Group 2
Subjects who previously received the Novartis MenACWY vaccine in the second year of life in V59P14 trial. Blood draw at 40 and 60 months of age, MenACWY injection at 60 months of age and a blood draw 28 days after the injection.
Biological: Meningococcal ACWY conjugate vaccine
Detailed safety will be collected for 7 days post injection and medically attended Adverse Events and SAEs for 28 days post injection.
Experimental: Group 3
Naïve subjects, age-matched with Group 1 and Group 2, enrolled at the 40 months of age. Blood draw at 40 months of age and an optional dose of MenACWY.
Biological: Meningococcal ACWY conjugate vaccine
Medically attended Adverse Events and SAEs will be collected for 28 days post injection.
Experimental: Group 4
Naïve subjects, age-matched with Group 1 and Group 2, enrolled at the 60 months of age. Blood draw at 60 months of age and dose of MenACWY. Blood draw 28 days after the injection.
Biological: Meningococcal ACWY conjugate vaccine
Detailed safety will be collected for 7 days post injection and medically attended Adverse Events and SAEs for 28 days post injection.

  Eligibility

Ages Eligible for Study:   37 Months to 63 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 on) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study.
  • 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 Criteria:

  • 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 trial (Groups 1 & 2 - follow on).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148017

Contacts
Contact: Novartis Drug Information Services +1 800 244 7668

Locations
United States, Alabama
Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615 Recruiting
Birmingham, Alabama, United States, 35205
United States, California
Premier Health Research 9317 Firestone Blvd. Recruiting
Downey, California, United States, 90241
Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624 Recruiting
Oakland, California, United States, 94611
Center for Clinical Trials, LLC 16660 Paramount Blvd., Suite 301 Recruiting
Paramount, California, United States, 90723
Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308 Recruiting
Paramount, California, United States, 90723
Kaiser Permanente Pleasanton 7601 Stoneridge Drive, Second Floor Recruiting
Pleasanton, California, United States, 94588
Kaiser Permanente San Francisco 2200 O'Farrell St., Sixth Floor Recruiting
San Francisco, California, United States, 94115
Kaiser Permanente Santa Clara 710 Lawrence Expressway, Pediatric Clinic Department Recruiting
Santa Clara, California, United States, 95051
United States, Illinois
Children's Memorial Hospital 2300 Children's Plaza, Box 155 Recruiting
Chicago, Illinois, United States, 60614
United States, Kentucky
Kentucky Pediatric/Adult Research 201 South Fifth Street, Suite 102 Recruiting
Bardstown, Kentucky, United States, 40004
United States, Maryland
28 Annapolis Pediatrics, 200 Forbes Street, Suite 200 Recruiting
Annapolis, Maryland, United States, 21401
United States, Ohio
Senders Pediatrics 2054 South Green Road Recruiting
Cleveland, Ohio, United States, 44121
United States, Pennsylvania
Children's Health Care 2501 West 12th Street Recruiting
Erie, Pennsylvania, United States, 16505
Pennridge Pediatric Associates 270 Main Street Recruiting
Harleyville, Pennsylvania, United States, 19438
Kid's Way Pediatrics 3068 Innovation Way Recruiting
Hermitage, Pennsylvania, United States, 16148
Pennridge Pediatric Associates 711 Lawn Avenue Recruiting
Sellersville, Pennsylvania, United States, 18960
Pediatric Medical Associates 1077 Rydal Road Recruiting
Suite 300 Rydal, Pennsylvania, United States, 19046
Pediatric Medical Associates 160 West Germantown Pike Recruiting
Suite D2 East Norriton, Pennsylvania, United States, 19402
PEAK Research 2859 Washington Rd., Ste. 412B Recruiting
Upper St. Clair, Pennsylvania, United States, 15241
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01148017     History of Changes
Other Study ID Numbers: V59P14E1
Study First Received: June 16, 2010
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Meningococcal
ACWY
Conjugate Vaccine
Meningitis
Children
Persistence
Booster dose

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningitis, Bacterial
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on April 15, 2014