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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01148017
First received: June 16, 2010
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

The primary objective was 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 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.


Condition Intervention Phase
Meningococcal Meningitis
Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 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:
  • Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y [ Time Frame: Visit 9 (continuation from the parent study), 40-month visit. ] [ Designated as safety issue: No ]
    The persistence of the antibody response in subjects of 40 months of age, previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.

  • Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y [ Time Frame: Visit 10, 60 months of age ] [ Designated as safety issue: No ]
    The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentages of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.


Secondary Outcome Measures:
  • Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age [ Time Frame: Visit 9, 40 months of age. ] [ Designated as safety issue: No ]
    The persistence of the antibody response in subjects of 40 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age [ Time Frame: Visit 10, 60 months of age. ] [ Designated as safety issue: No ]
    The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.

  • hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age [ Time Frame: Visit 9 (continuation from the parent study), 40-months of age. ] [ Designated as safety issue: No ]
    The persistence of the antibody response in children of 40 months of age previously vaccinated with MenACWY-CRM in study V59P14, and baseline antibody levels in age-matched naive subjects, is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.

  • hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age [ Time Frame: Visit 10, 60 months of age. ] [ Designated as safety issue: No ]
    The persistence of the antibody response in children of 60 months of age previously vaccinated with MenACWY-CRM in study V59P14, and baseline antibody levels in age-matched naive subjects is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.

  • Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination [ Time Frame: Visit 11, 1 month after vaccination. ] [ Designated as safety issue: No ]
    The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with hSBA titers ≥ 1:8 and ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y, at 1 month post-vaccination.

  • Percentage of Subjects With Seroresponse at 1 Month Post-vaccination [ Time Frame: Visit 11, 1 month after vaccination. ] [ Designated as safety issue: No ]

    The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study, compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with seroresponse at 1 month post-vaccination.

    Seroresponse is defined as hSBA ≥ 1:8 for subjects with pre-vaccination hSBA titer ≤1:4, and as at least a four-fold rise in hSBA for subjects with pre-vaccination hSBA titer ≥ 1:4.


  • Percentages of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity [ Time Frame: From day 1 to 7 after vaccination. ] [ Designated as safety issue: Yes ]

    Percentages of subjects reporting solicited local and systemic Adverse Events (AEs) and other indicators of reactogenicity after receiving study vaccination.

    Note: solicited AEs were not recorded for naive subjects at 40 months of age, but only SAEs and medically attended AEs.


  • Percentages of Subjects Reporting Unsolicited AEs and SAEs [ Time Frame: Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups). ] [ Designated as safety issue: Yes ]
    Percentages of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination.


Enrollment: 433
Study Start Date: July 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACWY - 4
Subjects who had previously received 4 doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in the parent study during their first year of life are administered one booster dose of the same vaccine at 60 months of age.
Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Experimental: ACWY - 2
Subjects who had previously received 1 or 2 doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Naïve - 40
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Active Comparator: Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

  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 up) 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
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: NCT01148017

Locations
United States, Alabama
Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
Birmingham, Alabama, United States, 35205
United States, California
Premier Health Research 9317 Firestone Blvd.
Downey, California, United States, 90241
Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624
Oakland, California, United States, 94611
Center for Clinical Trials, LLC 16660 Paramount Blvd., Suite 301
Paramount, California, United States, 90723
Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308
Paramount, California, United States, 90723
Kaiser Permanente Pleasanton 7601 Stoneridge Drive, Second Floor
Pleasanton, California, United States, 94588
Kaiser Permanente San Francisco 2200 O'Farrell St., Sixth Floor
San Francisco, California, United States, 94115
Kaiser Permanente Santa Clara 710 Lawrence Expressway, Pediatric Clinic Department
Santa Clara, California, United States, 95051
United States, Illinois
Children's Memorial Hospital 2300 Children's Plaza, Box 155
Chicago, Illinois, United States, 60614
United States, Kentucky
Kentucky Pediatric/Adult Research 201 South Fifth Street, Suite 102
Bardstown, Kentucky, United States, 40004
United States, Maryland
28 Annapolis Pediatrics, 200 Forbes Street, Suite 200
Annapolis, Maryland, United States, 21401
United States, Ohio
Senders Pediatrics 2054 South Green Road
Cleveland, Ohio, United States, 44121
United States, Pennsylvania
Children's Health Care 2501 West 12th Street
Erie, Pennsylvania, United States, 16505
Pennridge Pediatric Associates 270 Main Street
Harleyville, Pennsylvania, United States, 19438
Kid's Way Pediatrics 3068 Innovation Way
Hermitage, Pennsylvania, United States, 16148
Pennridge Pediatric Associates 711 Lawn Avenue
Sellersville, Pennsylvania, United States, 18960
Pediatric Medical Associates 1077 Rydal Road
Suite 300 Rydal, Pennsylvania, United States, 19046
Pediatric Medical Associates 160 West Germantown Pike
Suite D2 East Norriton, Pennsylvania, United States, 19402
PEAK Research 2859 Washington Rd., Ste. 412B
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
Results First Received: April 15, 2014
Last Updated: April 15, 2014
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
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on July 24, 2014