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

Meningitis Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728260
• Other study ID #: MTA38
• Status: Completed
• Phase: N/A
• First received: May 7, 2008
• Last updated: February 10, 2015
• Start date: July 2005
• Est. completion date: May 2013

Study information

• Verified date: February 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1421
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Receipt of Menactra vaccine during the study period.

Exclusion Criteria:

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Meningitis
• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• None administered in this study
N/A in this study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined	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	No
Primary	Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.	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	No
Primary	Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.	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	No

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