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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
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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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 ]
  Show Outcome Measure 1

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  
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 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 meninogcoccal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.

Measured Values
    Novartis MenACWY Vaccine     Licensed Meninogcoccal Vaccine  
Number of 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 )  

No statistical analysis provided for Percentage of Seroresponders, Ages 11 to 18 Years



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

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

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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

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


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@Novartis.com


No publications provided by Novartis

Publications automatically indexed to this study:


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