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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00856297
First received: March 2, 2009
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Meningococcal Meningitis
Biological: MenACWY-CRM conjugate vaccine
Biological: Licensed comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-Label, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Adolescents Who Previously Received Novartis MenACWY Conjugate Vaccine or Commercially Available MenACWY Conjugate Vaccine

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine [ Time Frame: 21 months, 3 years and 5 years postvaccination ] [ Designated as safety issue: No ]
    Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.


Secondary Outcome Measures:
  • Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine [ Time Frame: 21 months, 3 years and 5 years postvaccination ] [ Designated as safety issue: No ]
    Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y.

  • hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine [ Time Frame: 21 months, 3 years and 5 years postvaccination ] [ Designated as safety issue: No ]
    Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y.

  • Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Immune response of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

  • hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Immune response of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y.

  • Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine [ Time Frame: 1 month post booster vaccination ] [ Designated as safety issue: No ]
    Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

  • Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine [ Time Frame: 2 years postvaccination ] [ Designated as safety issue: No ]
    Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

  • Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine [ Time Frame: 2 years postvaccination ] [ Designated as safety issue: No ]
    Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y.

  • Number of Subjects Reporting Solicited Local and Systemic Adverse Events [ Time Frame: Day 1 to Day 7 ] [ Designated as safety issue: Yes ]
    Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point.

  • Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator [ Time Frame: Day 1 to 5 years ] [ Designated as safety issue: Yes ]
    Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine.

  • Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine [ Time Frame: 28 days postvaccination ] [ Designated as safety issue: Yes ]
    Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine.


Enrollment: 389
Study Start Date: February 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenACWY-CRM
Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
Biological: MenACWY-CRM conjugate vaccine
Active Comparator: Licensed comparator
Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
Biological: Licensed comparator
Other Name: Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier
Naive
Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
Biological: MenACWY-CRM conjugate vaccine Biological: Licensed comparator
Other Name: Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier
Experimental: MenACWY-CRM/MenACWY-CRM
Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Biological: MenACWY-CRM conjugate vaccine
Experimental: Licensed comparator/MenACWY-CRM
Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Biological: MenACWY-CRM conjugate vaccine Biological: Licensed comparator
Other Name: Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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 Criteria:

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.
  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: NCT00856297

Locations
United States, Alabama
37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615
Birmingham, Alabama, United States, 35205
United States, California
6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway
Fremont, California, United States, 94538
7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor
Fresno, California, United States, 93726
8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB
Hayward, California, United States, 94545
Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor
Oakland, California, United States, 94612
9 Kaiser Permanente Roseville 1840 Sierra Gardens Drive, Vaccine Studies
Roseville, California, United States, 95661
Kaiser Permanente, 6600 Bruceville Rd.
Sacramento, California, United States, 95823
11 Kaiser Permanente Sacramento 6600 Bruceville Rd., Pediatric Station C
Sacramento, California, United States, 95823
10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1
San Jose, California, United States, 95119
United States, Georgia
2 PAMPA 2155 Post Oak Tritt Road, Suite 100
Marietta, Georgia, United States, 30062
3 PAMPA 120 Stonebridge Parkway Ste. 410
Woodstock, Georgia, United States, 30189
United States, Kentucky
53 Pediatric/Adult Research Inc. 201 South Fifth Street, Suite 102
Bardstown, Kentucky, United States, 40004
United States, Ohio
38 Akron Children's Hospital One Perkins Square
Akron, Ohio, United States, 44308
43 Dr. Senders and Associates 2054 South Green Road
South Euclid, Ohio, United States, 44121
United States, Pennsylvania
19 Children's Health Care West 4671 West Lake Road
Erie, Pennsylvania, United States, 16505
21 Greenville Medical Centre Inc 90 Shenango Street
Greenville, Pennsylvania, United States, 16125
24 (seen at site 21) Family Healthcare Partners 420 Hillcrest Avenue
Grove City, Pennsylvania, United States, 16127
23 Pediatric Associates of Latrobe 210 Weldon Street
Latrobe, Pennsylvania, United States, 15650
13 Pediatric Alliance Southwestern 850 Clairton Blvd.
Pittsburgh, Pennsylvania, United States, 15236
14 Squirrel Hill Office 4070 Beechwood Blvd
Pittsburgh, Pennsylvania, United States, 15217
15 South Hills Pediatrics 4411 Stilley Road
Pittsburgh, Pennsylvania, United States, 15227
12 & 18 Primary Physicians Research, Inc. 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, United States, 15241
16 Pediatric Alliance Greentree Division 969 Greentree Road Suite 100
Pittsburgh, Pennsylvania, United States, 15220
Admin Primary Physicians Research, Inc. 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, United States, 15241
20 Pediatric Alliance Arcadia Division 9000 Perry Highway Suite 120
Pittsburgh, Pennsylvania, United States, 15237
35 Pennridge Pediatric Associates 711 Lawn Avenue
Sellersville, Pennsylvania, United States, 18960
22 Laurel Pediatrics 140 Wayland Smith Drive
Uniontown, Pennsylvania, United States, 15401
25 Family Practice Medical Associates South 2581 Washington Road Suite 211
Upper St. Clair, Pennsylvania, United States, 15241
PEAK Research, LLC, 2589 Washington Road, Suite 412B
Upper St. Clair, Pennsylvania, United States
United States, Texas
47 UTMB Galveston Office of Pediatric Clinical Trials Children's Hospital 301 University Blvd., Rm 1 288H
Galveston, Texas, United States, 77555
United States, Utah
56 J. Lewis Research, Inc/Foothill Family Clinic South 6360 South 3000 East, Suite 100
Salt Lake City, Utah, United States, 84121
United States, Washington
45 Group Health Research Institute 1730 Minor Ave, Suite 1600
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Novartis Vaccines
Novartis
Investigators
Study Chair: Novartis Vaccines Novartis
  More Information

Publications:
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00856297     History of Changes
Other Study ID Numbers: V59P13E1
Study First Received: March 2, 2009
Results First Received: October 24, 2013
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Meningococcal
ACWY
Conjugate Vaccine
Meningitis
Adolescents
Persistence

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

ClinicalTrials.gov processed this record on October 20, 2014