Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children

September 25, 2016 updated by: Sanofi Pasteur, a Sanofi Company

Post-licensure Safety Surveillance Study of Menactra® Vaccine When Administered As a 2-dose Schedule to Children 9 Months Through 23 Months of Age.

This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose. If a second dose is given within that time, then surveillance will be continued for six months following the second dose.

Observational Objective:

  • To describe and characterize adverse events occurring after vaccination with Menactra vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be carried out in collaboration with the Kaiser Permanente Medical Care Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC). KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter databases that capture all medical care received by enrollees.

Vaccination will be according to routine clinical practice. Vaccination databases will be reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.

Study Type

Observational

Enrollment (Actual)

116

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

9 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants at age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine according to routine clinical practice during the study period.

Description

Inclusion Criteria:

  • Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine during the study period.

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
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
Participants must have received Menactra Vaccine according to routine clinical practice.
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Names:
  • Menactra®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.
Time Frame: Day 0 up to Day 75 post-vaccination
Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.
Day 0 up to Day 75 post-vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database.
Time Frame: Day 0 up to Day 75 post-vaccination
Incidence rates for identified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Note: No events were identified in the hospital database.
Day 0 up to Day 75 post-vaccination
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database.
Time Frame: Day 0 up to Day 75 post-vaccination
Incidence rates for pre-specified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Pre-specified neurological conditions, hypersensitivity reactions, and new-onset autoimmune disease were selected for monitoring in the clinical database. Note: None of these events were identified in the clinic database.
Day 0 up to Day 75 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

June 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

September 25, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTA57
  • U 1111-1120-1574 (Other Identifier: WHO)

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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