Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00262041
First received: December 2, 2005
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.


Condition Intervention Phase
Prevention of Meningococcal Disease
Biological: MenACWY-CRM conjugate vaccine, adjuvanted
Biological: MenACWY-CRM conjugate vaccine, unadjuvanted
Biological: MenACWY polysaccharide vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Single-blind, Controlled, Multicenter Study to Compare the Safety and Immune Response of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With the Safety and Immune Response of One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Adolescents 11 to 17 Years of Age

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]
    Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers >1:4 directed against N meningitidis serogroups A, C, W and Y


Secondary Outcome Measures:
  • hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]
    Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, 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, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine [ Time Frame: 12 months after vaccination ] [ Designated as safety issue: No ]
    Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y.

  • hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine [ Time Frame: 12 months after vaccination ] [ Designated as safety issue: No ]
    Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.

  • Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination [ Time Frame: Day 1 to Day 7 ] [ Designated as safety issue: Yes ]
    Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.


Enrollment: 524
Study Start Date: October 2004
Estimated Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenACWY-CRM(Ad+)
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
Biological: MenACWY-CRM conjugate vaccine, adjuvanted
Experimental: MenACWY-CRM(Ad-)
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
Biological: MenACWY-CRM conjugate vaccine, unadjuvanted
Active Comparator: MenACWY- PS
Subjects received one single dose of the polysaccharide vaccine.
Biological: MenACWY polysaccharide vaccine

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Healthy adolescents between and including 11-17 years of age, who provide written informed consent

Exclusion Criteria:

  • Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or 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: NCT00262041

Locations
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15241
United States, Washington
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Novartis Vaccines
Novartis
Investigators
Study Director: Novartis Vaccines Novartis
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00262041     History of Changes
Other Study ID Numbers: V59P6, BB-IND 11278
Study First Received: December 2, 2005
Results First Received: September 9, 2013
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 20, 2014