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Trial record 1 of 1 for:    MTA30
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Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine

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ClinicalTrials.gov Identifier: NCT00254995
Recruitment Status : Completed
First Posted : November 17, 2005
Results First Posted : November 11, 2014
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:
To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.

Condition or disease Intervention/treatment
Meningitis Meningococcal Disease Biological: None administered in this study

Study Design
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Study Type : Observational
Actual Enrollment : 62626 participants
Observational Model: Cohort
Official Title: Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra ™)
Study Start Date : July 2005
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis Vaccines

Groups and Cohorts
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Group/Cohort Intervention/treatment
Menactra Vaccine Recipients
Participants who received Menactra vaccine as part of routine medical care during the study period in Kaiser Permanente.
 Biological: None administered in this study
N/A in this study
Age-Matched Control
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 as part of routine medical care during the same month 1 year earlier in Kaiser Permanente
 Biological: None administered in this study
N/A in this study


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.


Other Outcome Measures:
  1. 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 ]
    Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.

  2. 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 ]
    Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months for each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.

  3. 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 ]
    Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as (C) for pre-specified adverse events, (H) for hospital, (ER) for emergency room.

  4. 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 ]
    Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.

  5. 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 ]
    Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.

  6. 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 ]
    Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.

  7. 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 ]
    Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.

  8. 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 ]
    Only persons who received Menactra vaccine during the study period were included in this outcome.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Past receipt of Menactra vaccine
Criteria

Inclusion Criteria:

  • Receipt of Menactra vaccine during the study period.

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254995


Locations
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United States, California
Oakland, California, United States, 94612
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00254995    
Other Study ID Numbers: MTA30
First Posted: November 17, 2005    Key Record Dates
Results First Posted: November 11, 2014
Last Update Posted: April 19, 2016
Last Verified: April 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal disease
Menactra vaccine
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
 Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections