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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: November 3, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Meningitis
Meningococcal Disease
Biological: None administered in this study
Phase 4

Study Type: Observational
Study Design: 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 ™)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.

  • 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 ] [ Designated as safety issue: No ]
    Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.

  • 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 ] [ Designated as safety issue: No ]
    Only persons who received Menactra vaccine during the study period were included in this outcome.


Enrollment: 62626
Study Start Date: July 2005
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254995

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

Additional Information:
No publications provided

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: November 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Meningitis
Meningococcal disease
Menactra vaccine

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2014