36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds

February 10, 2015 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®) in Recipients 2 to 10 Years of Age.

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)

1421

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

No

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

  • Observational Models: Cohort

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Menactra Vaccine Recipients

Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They 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.

Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.

Menactra vaccine was administered according to routine clinical practice.
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 Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
Time Frame: Day 0 up to Day 30 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 comparison window. Clinical setting is given in parenthesis as (H) for hospital.
Day 0 up to Day 30 post-vaccination
Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
Time Frame: Day 31 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 each comparison window. Clinical setting is given in parenthesis as (H) for hospital.
Day 31 up to Day 180 post-vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - 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

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

May 7, 2008

First Submitted That Met QC Criteria

July 31, 2008

First Posted (Estimate)

August 5, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTA38

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.

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