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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00474487
First received: May 16, 2007
Last updated: December 9, 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 Meningitis
Meningococcal Infections
Interventions: 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)

  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
Subjects were enrolled at 3 centers in Argentina and Colombia.

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.

Reporting Groups
  Description
Novartis MenACWY Vaccine (19 to 55 Years) One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
Novartis MenACWY Vaccine (56 to 65 Years) One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
Licensed Conjugate Vaccine (19 to 55 Years) One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
Licensed Polysaccharide Vaccine (56 to 65 Years) One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.

Participant Flow:   Overall Study
    Novartis MenACWY Vaccine (19 to 55 Years)     Novartis MenACWY Vaccine (56 to 65 Years)     Licensed Conjugate Vaccine (19 to 55 Years)     Licensed Polysaccharide Vaccine (56 to 65 Years)  
STARTED     1606     217     899     109  
COMPLETED     1576     215     885     109  
NOT COMPLETED     30     2     14     0  
Withdrawal by Subject                 6                 0                 0                 0  
Lost to Follow-up                 20                 1                 7                 0  
Inappropriate enrollment                 4                 0                 7                 0  
Death                 0                 1                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Novartis MenACWY Vaccine (19 to 55 Years) One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
Novartis MenACWY Vaccine (56 to 65 Years) One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
Licensed Conjugate Vaccine (19 to 55 Years) One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
Licensed Polysaccharide Vaccine (56 to 65 Years) One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.
Total Total of all reporting groups

Baseline Measures
    Novartis MenACWY Vaccine (19 to 55 Years)     Novartis MenACWY Vaccine (56 to 65 Years)     Licensed Conjugate Vaccine (19 to 55 Years)     Licensed Polysaccharide Vaccine (56 to 65 Years)     Total  
Number of Participants  
[units: participants]
 		  1606     217     899     109     2831  
Age  
[units: Years]
Mean ± Standard Deviation 		  34.6  ± 10.1     60.1  ± 2.7     34.8  ± 10.4     60.1  ± 2.6     37.6  ± 12.6  
Gender  
[units: Subjects]
 		         
Female     1092     163     627     79     1961  
Male     514     54     272     30     870  
Race/Ethnicity, Customized  
[units: Subjects]
 		         
Asian     1     1     1     0     3  
Black     135     18     109     8     270  
Caucasian     249     38     127     23     437  
Hispanic     1217     158     658     77     2110  
Other     4     2     3     1     10  
Not Available     0     0     1     0     1  



  Outcome Measures
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1.  Primary:   Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years   [ Time Frame: Days 1 to 7 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population   [ Time Frame: 1 month postvaccination ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population   [ Time Frame: 1 month postvaccination ]
  Show Outcome Measure 3

4.  Secondary:   Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population   [ Time Frame: 1 month postvaccination ]
  Show Outcome Measure 4

5.  Secondary:   Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population   [ Time Frame: 1 month postvaccination ]
  Show Outcome Measure 5

6.  Secondary:   Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years   [ Time Frame: Days 1 to 7 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years   [ Time Frame: Days 1 to 7 ]
  Show Outcome Measure 7


  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


Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00474487     History of Changes
Other Study ID Numbers: V59P17
Study First Received: May 16, 2007
Results First Received: March 19, 2010
Last Updated: December 9, 2011
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica