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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00728260
First received: May 7, 2008
Last updated: February 10, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention
Meningitis
Meningococcal Disease
Biological: None administered in this study

Study Type: Observational
Study Design: Observational Model: Cohort
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.


Enrollment: 1421
Study Start Date: July 2005
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Past receipt of Menactra vaccine

Criteria

Inclusion Criteria:

  • Receipt of Menactra vaccine during the study period.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728260

Locations
United States, California
Oakland, California, United States, 94612
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00728260     History of Changes
Other Study ID Numbers: MTA38
Study First Received: May 7, 2008
Results First Received: January 7, 2015
Last Updated: February 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Meningitis
Meningococcal disease
Menactra vaccine

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on April 16, 2015