36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds
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|ClinicalTrials.gov Identifier: NCT00728260|
Recruitment Status : Completed
First Posted : August 5, 2008
Results First Posted : February 12, 2015
Last Update Posted : February 12, 2015
|Condition or disease||Intervention/treatment|
|Meningitis Meningococcal Disease||Biological: None administered in this study|
|Study Type :||Observational|
|Actual Enrollment :||1421 participants|
|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.|
|Study Start Date :||July 2005|
|Primary Completion Date :||May 2013|
|Study Completion Date :||May 2013|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728260
|United States, California|
|Oakland, California, United States, 94612|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|