A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

January 15, 2015 updated by: Novartis Vaccines

A Phase 3, Multi-center Study to Evaluate Lot to Lot Consistency, Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults and Compare to the Safety and Immune Response to a Licensed Conjugate Meningococcal ACWY Vaccine

This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.

Study Overview

Study Type

Interventional

Enrollment (Actual)

3539

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35205, 35244
      • Tuscaloosa, Alabama, United States, 35487
    • California
      • Fremont, California, United States, 94538
      • Fresno, California, United States, 93726
      • Hayward, California, United States, 94545
      • Oakland, California, United States, 94612
      • Roseville, California, United States, 95661
      • Sacramento, California, United States, 95817
      • San Jose, California, United States, 95119
    • Colorado
      • Denver, Colorado, United States, 80218
    • Georgia
      • Atlanta, Georgia, United States, 30062
      • Marietta, Georgia, United States, 30062
      • Woodstock, Georgia, United States, 30189
    • Illinois
      • Chicago, Illinois, United States, 60614
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
    • Maryland
      • Annapolis, Maryland, United States, 21401
      • Baltimore, Maryland, United States, 21201
      • Frederick, Maryland, United States, 21702
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
      • Fall River, Massachusetts, United States, 02124
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • Ohio
      • Akron, Ohio, United States, 44308
      • Cincinnati, Ohio, United States, 45229
      • South Euclid, Ohio, United States, 44121
    • Pennsylvania
      • Carnegie, Pennsylvania, United States, 15106
      • Erie, Pennsylvania, United States, 16505
      • Greenville, Pennsylvania, United States, 16125
      • Grove City, Pennsylvania, United States, 16127
      • Harleyville, Pennsylvania, United States, 19438
      • Jefferson Borough, Pennsylvania, United States, 15025
      • Latrobe, Pennsylvania, United States, 15650
      • Pittsburgh, Pennsylvania, United States, 15217 to 15241
      • Sellersville, Pennsylvania, United States, 18960
      • Uniontown, Pennsylvania, United States, 15401
      • Upper St. Clair, Pennsylvania, United States, 15241
      • Washington, Pennsylvania, United States, 15301
      • Wexford, Pennsylvania, United States, 15090
    • Texas
      • Galveston, Texas, United States, 77555-0371
    • Utah
      • Salt Lake City, Utah, United States, 84121
    • Washington
      • Seattle, Washington, United States, 98101-1466

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent

Exclusion Criteria:

  • Subjects with a previous or suspected disease caused by N. meningitidis
  • previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
  • previous or suspected disease caused by N. meningitidis
  • Any serious acute, chronic or progressive disease
  • Pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Licensed Meningococcal Vaccine
Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
EXPERIMENTAL: Novartis MenACWY Conjugate Vaccine
Novartis meningococcal ACWY conjugate Vaccine
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
Time Frame: 28 days after vaccination
The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)
28 days after vaccination
Percentage of Seroresponders, Ages 11 to 18 Years
Time Frame: 28 days after vaccination

Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).

Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

28 days after vaccination
Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
Time Frame: 6 days after vaccination

Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination.

Note: severe adverse events: unable to perform normal daily activity

6 days after vaccination
Percentage of Seroresponders, Ages 19 to 55 Years
Time Frame: 28 days after vaccination

Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age).

Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

28 days after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
Time Frame: 28 days after vaccination

The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).

Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

28 days after vaccination
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
Time Frame: 28 days after vaccination

Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).

Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

28 days after vaccination
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
Time Frame: 28 days after vaccination
Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).
28 days after vaccination
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Time Frame: Days 1 to 7
Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age).
Days 1 to 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

March 21, 2007

First Submitted That Met QC Criteria

March 21, 2007

First Posted (ESTIMATE)

March 22, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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