Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 to 10 Years of Age.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01682876
First received: September 7, 2012
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

This study is designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.


Condition Intervention Phase
Meningococcal Disease
Biological: MenACWY
Biological: Placebo-MenACWY
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of subjects with hSBA seroresponse [ Time Frame: Day 29 post dose 2 ] [ Designated as safety issue: No ]
    1. To demonstrate non inferiority of two doses (given 2 months apart) versus one dose of MenACWY-CRM vaccine, by age group (2 to 5 years of age; 6 to 10 years of age), as measured by the percentage of subjects with hSBA seroresponse directed against N. meningitidis serogroups A, C, W and Y, at 1 month after last vaccination.
    2. To demonstrate superiority of two doses (given 2 months apart) versus one dose of MenACWY-CRM vaccine, by age group (2 to 5 years of age; 6 to 10 years of age), as measured by the percentage of subjects with hSBA seroresponse directed against N. meningitidis serogroups A, C, W and Y, at 1 month after last vaccination.


Secondary Outcome Measures:
  • Percentage of subjects with hSBA ≥1:8 [ Time Frame: Day 365 post dose 2 ] [ Designated as safety issue: No ]
    To compare the immunogenicity of either 1 or 2 doses of MenACWY as measured by the percentage of subjects with hSBA > 1:8 and hSBA GMTs at 1 month and 12 months after last vaccination

  • hSBA GMTs [ Time Frame: Day 29 and Day 365 post dose 2 ] [ Designated as safety issue: No ]
    To compare the safety of either one or two doses of MenACWY-CRM vaccine (given 2 months apart), by age group (2 to 5 years of age; 6 to 10 years of age).

  • Solicited local and systemic reactions [ Time Frame: Days 1-7 postvaccination ] [ Designated as safety issue: Yes ]
  • Unsolicited Adverse Events [ Time Frame: Days 1-28 postvaccination ] [ Designated as safety issue: Yes ]
  • Medically attended Adverse Events [ Time Frame: Day 365 post dose 2 ] [ Designated as safety issue: Yes ]
  • Adverse Events leading to premature withdrawal [ Time Frame: Day 365 post dose 2 ] [ Designated as safety issue: Yes ]
  • Serious Adverse Events [ Time Frame: Day 365 post dose 2 ] [ Designated as safety issue: Yes ]

Enrollment: 716
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
2-5 years of age
Biological: MenACWY
2 dose vaccination schedule
Active Comparator: 2
2-5 years of age
Biological: Placebo-MenACWY
1 dose vaccination schedule
Experimental: 3
6-10 years of age
Biological: MenACWY
2 dose vaccination schedule
Active Comparator: 4
6-10 years of age
Biological: Placebo-MenACWY
1 dose vaccination schedule

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations

Exclusion Criteria:

  1. Unwilling or unable to give written informed assent or consent to participate in the study.
  2. Perceived to be unreliable or unavailable for the duration of the study period.
  3. Previous confirmed or suspected disease caused by N. meningitidis.
  4. Previously exposed to meningococcal disease/ bacterial meningitis.
  5. Previously immunized with a meningococcal vaccine (licensed or investigational).
  6. Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
  7. Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine.

    (certain exceptions influenza vaccines apply)

  8. Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment.
  9. Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
  10. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components
  11. Impairment/alteration of immune function, either congenital or acquired or resulting from (for example):

    • receipt of immunosuppressive therapy,
    • receipt of immunostimulants,
    • receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.
  12. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682876

Locations
United States, Alabama
Site 12 - Alabama Clinical Therapeutics, LLC 52 Medical Park East Drive, Suite 203
Birmingham, Alabama, United States, 35235
United States, California
Site 13 - Benchmark Research,1355 Florin Road, Suite 10
Sacramento, California, United States, 95822
United States, Florida
Site 5 - Altamonte Pediatric Associates 101 N Country Club Rd, Suite 115
Lake Mary, Florida, United States, 32746
United States, Georgia
Site 10 - Pediatrics and Adolescent Medicine 2155 Post Oak Tritt Rd, Suite 100
Marietta, Georgia, United States, 30062
Site 11 - Pediatrics and Adolescent Medicine 120 Stonebridge Parkway, Suite 410
Woodstock, Georgia, United States, 30189
United States, Iowa
Site 16 - Ridge Family Practice, 201 Ridge Street, Suite 201
Council Bluffs, Iowa, United States, 51503
United States, Kentucky
Site 3 - Bluegrass Clinical Research, Inc. 5512 Bardstown Rd, Suite 2
Louisville, Kentucky, United States, 40291
Site 4 - Bluegrass Clinical Research, Inc. 5512 Bardstown Rd, Suite 2
Louisville, Kentucky, United States, 40291
United States, Louisiana
Site 15 - Benchmark Research, 3800 Houma Blvd., Suite 345
Metaire, Louisiana, United States, 70006
United States, Michigan
Site 2 - Southwestern Medical Clinic
Niles, Michigan, United States, 49120
Site 7 - Southwestern Medical Clinic, Lakeland HealthCare Affiliate
Stevensville, Michigan, United States, 49127
United States, Nebraska
Site 18 - Bellevue Family Practice/Clinical Research Advantage 2206 Longo, Suite 201
Bellevue, Nebraska, United States, 68005
Site 6 - Meridian Clinical Research, Meridian Clinical Research 1103 Galvin Road South #G
Bellevue, Nebraska, United States, 68005
Site 17 - Prairie Fields Family Medicine/Clinical Research Advantage, Inc., 350 W. 23rd Street, Suite A
Fremont, Nebraska, United States, 68025
Site 24 - Pediatric Partners 750 East 29th St.
Fremont, Nebraska, United States, 68025
Site 1 - Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, New York
Site 14 - United Medical Associates, PC., 4417 Vestal Parkway East
Vestal, New York, United States, 13850
United States, Ohio
Site 23 - Rapid Medical Research, Inc., 3619 Park East Dr., Suite 300
Cleveland, Ohio, United States, 44122
Site 19 - Senders Pediatrics 2054 South Green Road
South Euclid, Ohio, United States, 44121
United States, Texas
Site 8 - Benchmark Research, 1015 E 32nd Street, Suite 303
Austin, Texas, United States, 78705
Site 9 - Benchmark Research, 4504 Boat Club Rd., Suite 400A
Ft. Worth, Texas, United States, 76135
United States, Utah
Site 20 - Advanced Clinical Research, 3590 West 9000 South, Suite 300
West Jordan, Utah, United States, 84088
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: NCT01682876     History of Changes
Other Study ID Numbers: V59_57
Study First Received: September 7, 2012
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Prevention of meningococcal disease, children, vaccine

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 21, 2014