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Completed

NCT Number: NCT01689155

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

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.

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Key information

Conditions

Meningitis Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infection Meningococcal Infections Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases

Age range

9 month–23 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Oakland, California, 94612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Biological

0.5 mL, Intramuscular

Other names: Menactra®

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Sep 21, 2012
Registry last updated
Nov 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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