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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00254995
Other study ID # MTA30
Secondary ID
Status Completed
Phase Phase 4
First received November 15, 2005
Last updated April 15, 2016
Start date July 2005
Est. completion date May 2013

Study information

Verified date April 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 62626
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Receipt of Menactra vaccine during the study period.

Exclusion Criteria:

Study Design

Observational Model: Cohort


Intervention

Biological:
None administered in this study
N/A in this study

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance 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. Day 0 up to Day 180 post-vaccination No
Other Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance 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. Day 0 up to Day 60 post-vaccination No
Other Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance 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. Day 0 up to Day 180 post-vaccination No
Other Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance 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. Day 0 up to Day 180 post-vaccination No
Other Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance 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. Day 0 up to Day 180 post-vaccination No
Other Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - All Ages Combined. Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome. Day 0 up to 6 months post-vaccination No
Other Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome. Day 0 up to 6 months post-vaccination No
Other Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination Only persons who received Menactra vaccine during the study period were included in this outcome. Day 0 up to Determination of Pregnancy Outcome No
Primary Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance 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. Day 0 up to Day 60 post-vaccination No
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