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A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00474487
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : August 4, 2010
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Description
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Brief Summary:
This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.

Condition or disease Intervention/treatment Phase
Meningococcal Meningitis Meningococcal Infections Biological: Meningococcal ACWY Polysaccharide Vaccine Biological: MenACWY CRM (19 to 55 years) Biological: Meningococcal ACWY Conjugate Vaccine Biological: Novartis MenACWY Vaccine (56 to 65 Years) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2831 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3, Multi-center Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adults and Compare to the Safety and Immune Response of a Licensed Conjugate Meningococcal ACWY Vaccine in Subjects Aged 19-55 Years of Age and to a Licensed Polysaccharide Vaccine in Subjects Aged 56-65 Years of Age.
Study Start Date : May 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines
Drug Information available for: Lactitol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Novartis MenACWY Vaccine (19 to 55 Years)
Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years
 Biological: MenACWY CRM (19 to 55 years)
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.
Active Comparator: Licensed polysaccharide vaccine
Licensed meningococcal ACWY polysaccharide vaccine
 Biological: Meningococcal ACWY Polysaccharide Vaccine
One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.
Active Comparator: Licensed Conjugate 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 by intramuscular injection.
Experimental: Novartis MenACWY Vaccine (56 to 65 Years)
Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years
 Biological: Novartis MenACWY Vaccine (56 to 65 Years)
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years [ Time Frame: Days 1 to 7 ]
    Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.


Secondary Outcome Measures :
  1. Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population [ Time Frame: 1 month postvaccination ]

    Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years).

    Seroresponse: 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.


  2. Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population [ Time Frame: 1 month postvaccination ]

    Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years).

    Seroresponse: 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.


  3. Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population [ Time Frame: 1 month postvaccination ]
    Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age.

  4. Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population [ Time Frame: 1 month postvaccination ]
    Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age.

  5. Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years [ Time Frame: Days 1 to 7 ]
    Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years).

  6. Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years [ Time Frame: Days 1 to 7 ]
    Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years).


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent
  • individuals who are available for all visits and telephone calls scheduled for the study;
  • individuals who are in good health

Exclusion Criteria:

  • individuals with a previous or suspected disease caused by N. meningitidis
  • individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
  • individuals with previous or suspected disease caused by N. meningitidis
  • individuals with any serious acute, chronic or progressive disease
  • individuals who are pregnant or breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474487


Locations
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Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina, C1406DGI
Colombia
Cali, Colombia; Bogota, Colombia
Cali; Bogota, Colombia
Sponsors and Collaborators
Novartis Vaccines
Investigators
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Study Director: Novartis Vaccines and Diagnostics Novartis
More Information
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Publications of Results:

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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00474487    
Other Study ID Numbers: V59P17
First Posted: May 17, 2007    Key Record Dates
Results First Posted: August 4, 2010
Last Update Posted: April 21, 2014
Last Verified: April 2014
Keywords provided by Novartis ( Novartis Vaccines ):
Meningococcal
meningitis
vaccine
adolescents
adults
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
 Bacterial Infections and Mycoses
Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs