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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Oakland, California, 94612, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Receipt of Menactra vaccine during the study period.

Exclusion criteria

None

Treatment and study plan

None administered in this study

Biological

N/A in this study

Primary outcomes

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.
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.

Other outcomes

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.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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.

Important dates

Study start: 2005
Primary completion: 2013
Study completion: 2013
First posted: Aug 5, 2008
Registry last updated: Feb 12, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed