Clinical trial NCT00254995: Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine
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 ™)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningitis
Meningococcal Disease
Keywords: Meningitis
Meningococcal disease
Menactra vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 62626
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Past receipt of Menactra vaccine

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Receipt of Menactra vaccine during the study period.

Exclusion Criteria:

* None

Primary outcomes:
measure: Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance
timeFrame: Day 0 up to Day 60 post-vaccination
Secondary outcomes:
Other outcomes:
measure: Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
timeFrame: Day 0 up to Day 180 post-vaccination
measure: Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance
timeFrame: Day 0 up to Day 60 post-vaccination
measure: Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
timeFrame: Day 0 up to Day 180 post-vaccination
measure: Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance
timeFrame: Day 0 up to Day 180 post-vaccination
measure: Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance
timeFrame: Day 0 up to Day 180 post-vaccination
measure: Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - All Ages Combined.
timeFrame: Day 0 up to 6 months post-vaccination
measure: Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
timeFrame: Day 0 up to 6 months post-vaccination
measure: Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination
timeFrame: Day 0 up to Determination of Pregnancy Outcome
Locations:
city: Oakland
country: United States
state: California
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hansen J, Zhang L, Klein NP, Robertson CA, Decker MD, Greenberg DP, Bassily E, Baxter R. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine. Vaccine. 2017 Dec 14;35(49 Pt B):6879-6884. doi: 10.1016/j.vaccine.2017.09.032. Epub 2017 Sep 21.