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Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00254995
First received: November 15, 2005
Last updated: April 15, 2016
Last verified: April 2016
Results First Received: September 4, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort
Conditions: Meningitis
Meningococcal Disease
Intervention: Biological: None administered in this study

  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
Study participant accrual occurred from 15 July 2005 through 14 April 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Databases were reviewed to identify persons who received Menactra vaccine within Kaiser Permanente and to identify all medical care events for the 6-month period following vaccination or, if applicable, through the end of pregnancy. Subjects served as their own control for 0-30 days surveillance, age-matched control served for the 6-month period.

Reporting Groups
  Description
Menactra Vaccine Recipients

Kaiser Permanente members who received Menactra vaccine during the study period.

Kaiser Permanente databases were used; Menactra vaccine was administered according to routine clinical practice.

Control Group

Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0–30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.

Kaiser Permanente databases were used; Menactra and control vaccine were administered according to routine clinical practice.


Participant Flow:   Overall Study
    Menactra Vaccine Recipients   Control Group
STARTED   31561   31065 
COMPLETED   31561   31065 
NOT COMPLETED   0   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.
Subjects who received Menactra vaccine during the study period from the Kaiser Permanente databases.

Reporting Groups
  Description
Menactra Vaccine Recipients

Kaiser Permanente members who received Menactra vaccine during the study period.

Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study.

Control Group

Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0–30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.

Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study.

Total Total of all reporting groups

Baseline Measures
   Menactra Vaccine Recipients   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 31561   31065   62626 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.6  (5.56)   15.65  (5.56)   15.6  (5.56) 
Age 
[Units: Participants]
     
<=18 years   26805   26383   53188 
Between 18 and 65 years   4732   4658   9390 
>=65 years   24   24   48 
Gender [1] 
[Units: Participants]
     
Female   15722   15369   31091 
Male   15836   15696   31532 
[1] Gender information for 3 participants was not available in the database.
Region of Enrollment 
[Units: Participants]
     
United States   31561   31065   62626 
Seasonality [1] 
[Units: Participants]
     
December - February   4689   4671   9360 
March - May   3605   3602   7207 
June - August   17577   17080   34657 
September - November   5739   5712   11451 
[1] Data represents participants receiving vaccine each season or time period shown. Some participants (49) had received more than one dose of Menactra vaccine are counted for each dose in the seasonality section.


  Outcome Measures
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1.  Primary:   Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined – Short-Term Passive Surveillance   [ Time Frame: Day 0 up to Day 60 post-vaccination ]

2.  Other Pre-specified:   Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – All Ages Combined – Long-Term Passive Surveillance   [ Time Frame: Day 0 up to Day 180 post-vaccination ]

3.  Other Pre-specified:   Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons – By Age Categories – Short-Term Passive Surveillance   [ Time Frame: Day 0 up to Day 60 post-vaccination ]

4.  Other Pre-specified:   Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – By Age Categories – Long-Term Passive Surveillance   [ Time Frame: Day 0 up to Day 180 post-vaccination ]

5.  Other Pre-specified:   Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – All Ages Combined – Long-Term Passive Surveillance   [ Time Frame: Day 0 up to Day 180 post-vaccination ]

6.  Other Pre-specified:   Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – By Age Categories – Long-Term Passive Surveillance   [ Time Frame: Day 0 up to Day 180 post-vaccination ]

7.  Other Pre-specified:   Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination – ER Setting – All Ages Combined.   [ Time Frame: Day 0 up to 6 months post-vaccination ]

8.  Other Pre-specified:   Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination – Hospital Setting – All Ages Combined   [ Time Frame: Day 0 up to 6 months post-vaccination ]

9.  Other Pre-specified:   Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination   [ Time Frame: Day 0 up to Determination of Pregnancy Outcome ]


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Drector
Organization: Sanofi Pasteur Inc
e-mail: RegistryContactus@sanofipasteur.com



Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00254995     History of Changes
Other Study ID Numbers: MTA30
Study First Received: November 15, 2005
Results First Received: September 4, 2014
Last Updated: April 15, 2016
Health Authority: United States: Food and Drug Administration