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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: January 15, 2015
Last verified: January 2015
Results First Received: March 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Meningococcal Infections
Meningococcal Meningitis
Interventions: Biological: MenACWY CRM
Biological: Meningococcal ACWY Conjugate vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 44 centers in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects enrolled were included in the trial. All enrolled subjects were randomized at a 1:1:1:1 ratio to receive one of the four vaccine groups.

Reporting Groups
  Description
Novartis MenACWY Vaccine (11 to 18 Years) One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
Licensed Meningococcal Vaccine (11 to 18 Years) One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
Novartis MenACWY Vaccine (19 to 55 Years) One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
Licensed Meningococcal Vaccine (19 to 55 Years) One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.

Participant Flow:   Overall Study
    Novartis MenACWY Vaccine (11 to 18 Years)   Licensed Meningococcal Vaccine (11 to 18 Years)   Novartis MenACWY Vaccine (19 to 55 Years)   Licensed Meningococcal Vaccine (19 to 55 Years)
STARTED   1640   540   1023   336 
COMPLETED   1594   524   999   325 
NOT COMPLETED   46   16   24   11 
Withdrawal by Subject                10                2                0                1 
Lost to Follow-up                31                12                19                9 
Protocol Violation                0                1                0                1 
Inappropriate enrollment                4                1                3                0 
Administrative reason                0                0                1                0 
Unable to Classify                1                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Novartis MenACWY Vaccine One dose of the Novartis meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly.
Licensed Meningococcal Vaccine One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Total Total of all reporting groups

Baseline Measures
   Novartis MenACWY Vaccine   Licensed Meningococcal Vaccine   Total 
Overall Participants Analyzed 
[Units: Participants]
 2663   876   3539 
Age 
[Units: Years]
Mean (Standard Deviation)
     
11 to 18 years   14.2  (2.2)   14.1  (2.2)   14.2  (14.1) 
19 to 55 years   39.0  (9.6)   38.7  (9.9)   39  (38.7) 
Gender, Customized 
[Units: Participants]
     
Female (11 to 18 years)   769   251   1020 
Male (11 to 18 years)   871   289   1160 
Female (19 to 55 years)   774   252   1026 
Male (19 to 55 years)   249   84   333 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian (11 to 18 years)   45   17   62 
Black (11 to 18 years)   138   45   183 
Caucasian (11 to 18 years)   1280   423   1703 
Hispanic (11 to 18 years)   126   34   160 
Other (11 to 18 years)   51   21   72 
Asian (19 to 55 years)   37   8   45 
Black (19 to 55 years)   85   34   119 
Caucasian (19 to 55 years)   828   261   1089 
Hispanic (19 to 55 years)   60   29   89 
Other (19 to 55 years)   13   4   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Percentage of Seroresponders, Ages 11 to 18 Years   [ Time Frame: 28 days after vaccination ]
  Hide Outcome Measure 2

Measure Type Primary
Measure Title Percentage of Seroresponders, Ages 11 to 18 Years
Measure Description

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.

Time Frame 28 days after vaccination  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis set was the per protocol (PP) population.

Reporting Groups
  Description
Novartis MenACWY Vaccine One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
Licensed Meninogcoccal Vaccine One vaccination of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.

Measured Values
   Novartis MenACWY Vaccine   Licensed Meninogcoccal Vaccine 
Participants Analyzed 
[Units: Participants]
 1075   359 
Percentage of Seroresponders, Ages 11 to 18 Years 
[Units: Percentage of participants]
Number (95% Confidence Interval)
   
Serogroup A   75 
 (72 to 77) 
 66 
 (61 to 71) 
Serogroup C (N= 1483, 501)   75 
 (73 to 77) 
 73 
 (69 to 77) 
Serogroup W (N= 1024, 288)   75 
 (72 to 77) 
 63 
 (57 to 68) 
Serogroup Y (N= 1036, 294)   68 
 (65 to 71) 
 41 
 (35 to 47) 


Statistical Analysis 1 for Percentage of Seroresponders, Ages 11 to 18 Years
Groups [1] All groups
Statistical Test Type [2] Non-Inferiority or Equivalence
Statistical Method [3] ANOVA
Vaccine group difference [4] 8
95% Confidence Interval 3 to 14
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Seroresponders, Ages 11 to 18 Years
Groups [1] All groups
Statistical Test Type [2] Non-Inferiority or Equivalence
Statistical Method [3] ANOVA
Vaccine group difference [4] 2
95% Confidence Interval -2 to 7
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Percentage of Seroresponders, Ages 11 to 18 Years
Groups [1] All groups
Statistical Test Type [2] Non-Inferiority or Equivalence
Statistical Method [3] ANOVA
Vaccine group difference [4] 12
95% Confidence Interval 6 to 18
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Percentage of Seroresponders, Ages 11 to 18 Years
Groups [1] All groups
Statistical Test Type [2] Non-Inferiority or Equivalence
Statistical Method [3] ANOVA
Vaccine group difference [4] 27
95% Confidence Interval 20 to 33
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



3.  Primary:   Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years   [ Time Frame: 6 days after vaccination ]

4.  Primary:   Percentage of Seroresponders, Ages 19 to 55 Years   [ Time Frame: 28 days after vaccination ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years   [ Time Frame: 28 days after vaccination ]

8.  Secondary:   Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years   [ Time Frame: Days 1 to 7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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