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A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and 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: NCT00450437
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : September 24, 2010
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Tracking Information
First Submitted Date  ICMJE March 21, 2007
First Posted Date  ICMJE March 22, 2007
Results First Submitted Date  ICMJE March 19, 2010
Results First Posted Date  ICMJE September 24, 2010
Last Update Posted Date January 28, 2015
Study Start Date  ICMJE March 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
  • 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)
  • 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.
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2007)
  • Immunogenicity of Novartis MenACWY compared with immunogenicity of a single dose of licensed meningococcal ACWY conjugate vaccine defined as measured by serum bactericidal activity one month after vaccination.
  • Safety of Novartis MenACWY compared with that of licensed meningococcal ACWY conjugate vaccine as measured by the percentage of subjects presenting at least one severe systemic reaction during the first 7 days (Day 1-7) following a single dose.
  • To assess the consistency of 3 manufactured lots as measured by geometric mean titers of serum bactericidal antibodies measured one month after vaccination.
Change History Complete list of historical versions of study NCT00450437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2010)
  • 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.
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2007)
Safety and tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningococcal Infections
  • Meningococcal Meningitis
Intervention  ICMJE
  • Biological: MenACWY CRM
    One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
  • Biological: Meningococcal ACWY Conjugate vaccine
    One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Study Arms  ICMJE
  • Active Comparator: Licensed Meningococcal Vaccine
    Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
    Intervention: Biological: Meningococcal ACWY Conjugate vaccine
  • Experimental: Novartis MenACWY Conjugate Vaccine
    Novartis meningococcal ACWY conjugate Vaccine
    Intervention: Biological: MenACWY CRM
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2010)
3539
Original Enrollment  ICMJE
 (submitted: March 21, 2007)
3000
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00450437
Other Study ID Numbers  ICMJE V59P13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Vaccines )
Study Sponsor  ICMJE Novartis Vaccines
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Vaccines and Diagnostics Novartis
PRS Account Novartis
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP