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: April 1, 2014
Last verified: April 2014
Results First Received: March 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   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 48 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  
Number of Participants  
[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
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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 ]
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Measure Type Primary
Measure Title Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
Measure Description 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)
Time Frame 28 days after vaccination  
Safety Issue No  

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 was performed on the Per Protocol (PP) Population

Reporting Groups
  Description
Novartis MenACWY Lot 1 One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
Novartis MenACWY Lot 2 One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
Novartis MenACWY Lot 3 One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.

Measured Values
    Novartis MenACWY Lot 1     Novartis MenACWY Lot 2     Novartis MenACWY Lot 3  
Number of Participants Analyzed  
[units: participants]
  359     357     359  
Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years  
[units: Titers]
Geometric Mean ( 95% Confidence Interval )
     
Serogroup A     29  
  ( 23 to 38 )  
  33  
  ( 25 to 42 )  
  31  
  ( 24 to 40 )  
Serogroup C (N=499, 493, 491)     77  
  ( 58 to 102 )  
  58  
  ( 43 to 77 )  
  64  
  ( 48 to 86 )  
Serogroup W (N=340, 341, 343)     87  
  ( 70 to 108 )  
  111  
  ( 89 to 138 )  
  82  
  ( 66 to 102 )  
Serogroup Y (N=345, 345, 346)     48  
  ( 37 to 62 )  
  61  
  ( 47 to 79 )  
  53  
  ( 41 to 69 )  

No statistical analysis provided for Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years



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

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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