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A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01018732
First Posted: November 25, 2009
Last Update Posted: July 15, 2015
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.
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
Results First Submitted: August 9, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Meningococcal Disease
Meningococcal Meningitis
Intervention: Biological: Novartis Meningococcal (MenACWY-CRM) 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 3 centers in the USA

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
I: MenACWY-CRM Vaccine Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
II: Licensed Polysaccharide Meningococcal Vaccine Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
III: Meningococcal Naive Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive

Participant Flow:   Overall Study
    I: MenACWY-CRM Vaccine   II: Licensed Polysaccharide Meningococcal Vaccine   III: Meningococcal Naive
STARTED   50   51   54 
COMPLETED   49   49   50 
NOT COMPLETED   1   2   4 
Lost to Follow-up                0                0                3 
Protocol Violation                1                1                0 
Inappropriate Enrollment                0                1                0 
Unable to Classify                0                0                1 



  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
I: MenACWY-CRM Vaccine Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
II: Licensed Polysaccharide Meningococcal Vaccine Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
III: Meningococcal Naive Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
Total Total of all reporting groups

Baseline Measures
   I: MenACWY-CRM Vaccine   II: Licensed Polysaccharide Meningococcal Vaccine   III: Meningococcal Naive   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   51   54   155 
Age 
[Units: Years]
Mean (Standard Deviation)
 18.8  (1.9)   19.2  (2.0)   20.5  (2.3)   19.5  (2.1) 
Gender 
[Units: Participants]
       
Female   22   28   33   83 
Male   28   23   21   72 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination   [ Time Frame: Day 1 (5 years after primary vaccination) ]

2.  Primary:   Geometric Mean Titer After Booster Vaccination   [ Time Frame: Day 8, Day 29 (5 years after primary vaccination) ]

3.  Secondary:   Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination   [ Time Frame: Day 1 (5 years after primary vaccination ) ]

4.  Secondary:   Geometric Mean Titer at 5 Years After Primary Vaccination   [ Time Frame: Day 1 (5 years after primary vaccination ) ]

5.  Secondary:   Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination   [ Time Frame: Day 7, Day 28 post booster (5 years after primary vaccination) ]

6.  Secondary:   Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination   [ Time Frame: Day 7, Day 28 post booster (5 years after primary vaccination) ]

7.  Secondary:   Geometric Mean Ratio After Booster Vaccination   [ Time Frame: Day 8 and Day 29 (at 5 Years After Primary Vaccination) ]

8.  Secondary:   Percentage of Subjects With hSBA Seroresponse After Booster Vaccination   [ Time Frame: Day 8, Day 29 (5 years after primary vaccination) ]

9.  Secondary:   Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination   [ Time Frame: Up to Day 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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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


Publications of Results:

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01018732     History of Changes
Other Study ID Numbers: V59P6E1
First Submitted: November 18, 2009
First Posted: November 25, 2009
Results First Submitted: August 9, 2011
Results First Posted: September 13, 2011
Last Update Posted: July 15, 2015