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

April 15, 2016 updated by: Sanofi Pasteur, a Sanofi Company

Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra ™)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

62626

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Past receipt of Menactra vaccine

Description

Inclusion Criteria:

  • Receipt of Menactra vaccine during the study period.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 up to Day 60 post-vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 up to Day 180 post-vaccination
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.
Day 0 up to Day 60 post-vaccination
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.
Day 0 up to Day 180 post-vaccination
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.
Day 0 up to Day 180 post-vaccination
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.
Day 0 up to Day 180 post-vaccination
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.
Day 0 up to 6 months post-vaccination
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.
Day 0 up to 6 months post-vaccination
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.
Day 0 up to Determination of Pregnancy Outcome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

November 15, 2005

First Submitted That Met QC Criteria

November 15, 2005

First Posted (Estimate)

November 17, 2005

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTA30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe