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

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

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.

Study Overview

• Status: Completed
• Conditions: Meningococcal Meningitis
• Intervention / Treatment: Biological: MenACWY-CRM conjugate vaccine; Biological: Licensed comparator

• Study Type: Interventional
• Enrollment (Actual): 389
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier
Other: 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 Names: 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 Names: Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	21 months, 3 years and 5 years postvaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine	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.	21 months, 3 years and 5 years postvaccination
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine	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.	21 months, 3 years and 5 years postvaccination
Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8	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.	day 1
hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination	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.	day 1
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine	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.	1 month post booster vaccination
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine	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.	2 years postvaccination
Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine	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.	2 years postvaccination
Number of Subjects Reporting Solicited Local and Systemic Adverse Events	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.	Day 1 to Day 7
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator	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.	Day 1 to 5 years
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine	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.	28 days postvaccination

Collaborators and Investigators

• Sponsor: Novartis Vaccines
• Collaborators: GlaxoSmithKline
• Investigators: Study Chair: Novartis Vaccines, Novartis

Publications and helpful links

General Publications

• Gill CJ, Baxter R, Anemona A, Ciavarro G, Dull P. Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo(R)) or Menactra(R) among healthy adolescents. Hum Vaccin. 2010 Nov;6(11):881-7. doi: 10.4161/hv.6.11.12849. Epub 2010 Nov 1.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: March 2, 2009
• First Submitted That Met QC Criteria: March 4, 2009
• First Posted (Estimate): March 5, 2009

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Adolescents; Meningitis; Persistence; Conjugate Vaccine; Meningococcal; ACWY
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Meningitis, Meningococcal; Meningitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: V59P13E1