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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00450437
First received: March 21, 2007
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Meningococcal Infections
Meningococcal Meningitis
 Biological: MenACWY CRM
Biological: Meningococcal ACWY Conjugate vaccine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Lactitol
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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)

  • Percentage of Seroresponders, Ages 11 to 18 Years [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]

    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.


  • Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years [ Time Frame: 6 days after vaccination ] [ Designated as safety issue: Yes ]

    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


  • Percentage of Seroresponders, Ages 19 to 55 Years [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]

    Immunogencity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed menigococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meninitidis 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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]
    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).

  • Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 3539
Study Start Date: March 2007
Study Completion Date: January 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Licensed Meningococcal Vaccine
Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
 Biological: Meningococcal ACWY 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
 Biological: MenACWY CRM
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.

  Eligibility

Ages Eligible for Study:   11 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450437

  Show 41 Study Locations
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Director: Novartis Vaccines and Diagnostics Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00450437     History of Changes
Other Study ID Numbers: V59P13
Study First Received: March 21, 2007
Results First Received: March 19, 2010
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Meningococcal
meningitis
vaccine
adolescents
adults

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
 Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Lactitol
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013