Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age

To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.

Study Overview

• Status: Completed
• Conditions: Meningococcal Infections
• Intervention / Treatment: Biological: MenACWY-CRM; Biological: MenACWY-CRM; Biological: Licensed meningococcal ACWY vaccine

• Study Type: Interventional
• Enrollment (Actual): 2907
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Mount Pearl, Canada, A1N 1W7
    • Commonwealth Medical Clinic
  • Saint John's, Canada, A1A 3R5
    • White Hills Medical Clinic
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 8P8
      • TASC Research Services Inc.
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
      • Manitoba Clinic
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Clinical Trials Research Center
    • Truro, Nova Scotia, Canada, B2N 1L2
      • Colchester Regional Hospital
  • Ontario
    • Etobicoke, Ontario, Canada, M9V 4B4
      • Albion Finch Medical Centre
    • London, Ontario, Canada, N6A 1V2
      • Children's Hospital of Western Ontario
    • Newmarket, Ontario, Canada, L3Y 5G8
      • SKDS Research In.
    • Ottawa, Ontario, Canada, K1S 0G8
      • Herridge Community Health Clinic
    • Sarnia, Ontario, Canada, N7T 4X3
      • Sarnia Institute of Clinical Research
    • Sudbury, Ontario, Canada, P3E 1H5
      • Medicor Research Inc.
    • Toronto, Ontario, Canada, M5G 1N8
      • Resolve Research Solutions
    • Toronto, Ontario, Canada, M5M 1B2
      • Resolve Research Solutions
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 8T5
      • Queen Elizabeth Hospital
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
• United States
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Children's Investigational Reserach Program
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Pediatric Research Group
  • California
    • Downey, California, United States, 90241
      • Premier Health Research Center
    • Fremont, California, United States, 94538
      • Kaiser Permanente - Fremont
    • Fresno, California, United States, 93726
      • Kaiser Permanente - Fresno
    • Hayward, California, United States, 94545
      • Kaiser Permanente - Hayward
    • Oakland, California, United States, 94611
      • Kaiser Permanente - Oakland
    • Pleasanton, California, United States, 94566
      • Kaiser Permanente - Pleasanton
    • San Francisco, California, United States, 94115
      • Kaiser Permanente - San Francisco
    • San Jose, California, United States, 95119
      • Kaiser Permanente - San Jose
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Kaiser Permanente - Aurora
    • Centennial, Colorado, United States, 80112
      • 1st Allergy & Clinical Research
    • Longmont, Colorado, United States, 80501
      • Longmont Medical Research Network
    • Thornton, Colorado, United States, 80233
      • 1st Allergy & Clinical Research
    • Westminister, Colorado, United States, 80234
      • Kaiser Permanente - Westminister
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric Research Center
    • Springfield, Kentucky, United States, 40004
      • Physicians to Children & Adolescents
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Benchmark Research
  • Missouri
    • St. Louis, Missouri, United States, 63104
      • St. Louis University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research LLC
  • New York
    • Rochester, New York, United States, 14618
      • Legacy Pediatrics
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Durham Pediatrics
    • Durham, North Carolina, United States, 27704
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27704
      • Regional Pediatric Associates PA
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Odyssey Research
  • Ohio
    • Cleveland, Ohio, United States, 44121
      • Dr. Senders and Associates
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Calcagno Research & Development
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16505
      • Children's Health Care - West
    • Greenville, Pennsylvania, United States, 16125
      • University of Pittsburgh Medical Center
    • Grove City, Pennsylvania, United States, 16127
      • Family Healthcare Partners
    • Latrobe, Pennsylvania, United States, 15650
      • Pediatric Associates of Latrobe
    • Pittsburg, Pennsylvania, United States, 15237
      • Primary Physicians Research Inc.
    • Pittsburgh, Pennsylvania, United States, 15227
      • South Hills Pediatrics
    • Pittsburgh, Pennsylvania, United States, 15241
      • Primary Physicians Research Inc.
    • Pittsburgh, Pennsylvania, United States, 15217
      • Pediatric Alliance PC
    • Pittsburgh, Pennsylvania, United States, 15220
      • Pediatric Alliance PC
    • Pittsburgh, Pennsylvania, United States, 15236
      • Pediatric Alliance PC
    • Uniontown, Pennsylvania, United States, 15401
      • Laurel Pediatrics
    • Upper St. Clair, Pennsylvania, United States, 15241
      • Family Practice Medical Associates South
    • Wexford, Pennsylvania, United States, 15090
      • Children's Community Pediatrics
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Jackson Clinic Professional Association
  • Texas
    • Fort Worth, Texas, United States, 76135
      • Benchmark Research Ft. Worth
    • San Angelo, Texas, United States, 76904
      • Benchmark Research San Angelo
  • Utah
    • Clinton, Utah, United States, 84015
      • Jean Brown Research
    • Layton, Utah, United States, 84041
      • Wee Care Pediatrics
    • Murray, Utah, United States, 84107
      • Cottonwood Pediatrics
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research Inc.
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research Inc.
    • South Jordan, Utah, United States, 84095
      • CopperView Medical Center
  • Washington
    • Spokane, Washington, United States, 99202
      • Rockwood Clinic
    • Spokane, Washington, United States, 99218
      • Rockwood Clinic North

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
• who are available for all visits and telephone calls scheduled for the study
• who are up-to-date with age-appropriate routine childhood vaccinations

Exclusion Criteria:

• whose parent or legal guardian is unwilling or unable to give written informed consent
• who had a previous or suspected disease caused by N. meningitidis;
• who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
• who have received any investigational agents or vaccines within 90 days prior to enrollment
• who have any serious acute, chronic or progressive disease
• who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
• who have a history of anaphylaxis, serious vaccine reactions
• who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
• who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
• who have Down's syndrome or other known cytogenic disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MenACWY-CRM (1 dose); 1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1.	Biological: MenACWY-CRM; 1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly; Other Names: Menveo; Biological: MenACWY-CRM; 2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age; Other Names: Menveo
Active Comparator: Licensed polysaccharide vaccine; 1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1	Biological: Licensed meningococcal ACWY vaccine; 1 injection of the licensed meningococcal ACWY was administered intramuscularly; Other Names: Menactra
Experimental: MenACWY-CRM (2 doses); 2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61.	Biological: MenACWY-CRM; 1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly; Other Names: Menveo; Biological: MenACWY-CRM; 2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age; Other Names: Menveo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age	The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.	1 month postvaccination
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.	The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.	1 month postvaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.	The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.	1 month postvaccination
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age	The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.	1 month postvaccination
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.	The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.	1 month postvaccination
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.	The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.	1 month postvaccination
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.	The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.	1 month postvaccination
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)	The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.	1 month postvaccination
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)	The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.	1 month postvaccination
GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)	The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y. ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets.	1 month postvaccination
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.	Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment.	Study days 1 to 7
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.	Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment.	Study days 1 to 7
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.	Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.	day 1 to study termination (day 240)

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Publications and helpful links

General Publications

• Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: January 31, 2008
• First Submitted That Met QC Criteria: February 14, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): February 15, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: vaccine; children; meningitis; healthy; Menveo; meningococcal; prevention of meningococcal disease serogroups ACWY
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: V59P20; 11278 (Registry Identifier: DAIDS ES Registry Number)