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|
|Actual Primary Completion Date :||May 2013|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|