Clinical trial NCT01452438: Safety Surveillance of MenACWY-CRM Vaccine in Children
Official title: Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (Menveo) Vaccination in Children 2 Through 10 Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningococcal Disease
Keywords: observational
serogroup A, B, Y, W
meningococcal meningitis
meningococcal vaccines
safety
MenACYW-CRM
post-marketing
children
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-10-14
Enrollment: 393
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is selected from the Health Maintenance Organization population of the Kaiser Permanente Southern California (KPSC) HMO in Pasadena, CA, USA.

Brief summary: The purpose of this study is to summarize the occurrence of incident serious medically attended events and events of interest up to 1 year following MenACWY-CRM vaccination administered as part of routine clinical care. This US FDA post-marketing commitment study is an open-label, descriptive, epidemiological safety surveillance study of MenACWY-CRM vaccine in subjects 2 to 10 years of age within a large US Healthcare Maintenance Organization. The 26 events of interest are events commonly evaluated in vaccine safety studies and include certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All events are collected retrospectively.

Detailed description: This is an observational study, vaccines administration and data that is collected is only as part of routine clinical care. Vaccinated subjects are not actively recruited.

Events of Interest: Diabetes Mellitus, Rheumatoid arthritis, Idiopathic Thrombocytopenic Purpura, Iridocyclitis, Acute glomerulonephritis, Nephrotic syndrome, Grave's disease, Autoimmune hemolytic anemia, Myasthenia Gravis, New onset asthma, Allergic urticaria, Anaphylaxis, Meningococcal Disease, Intentional Injury

Eligibility criteria: Inclusion Criteria:

* Registered with the HMO for at least 6 months prior to vaccination.
* Between the ages of 2 and 10 years (inclusive - i.e. has not reached their 11th birthday) at the time of the vaccination.
* Received any MenACWY-CRM vaccination during the vaccination period at the participating centers.

Exclusion Criteria:

* None

Primary outcomes:
measure: Timing relative to vaccination date (mean days (SD)) for all serious medically attended events and events of interest
timeFrame: Observational period of 1 year following date of vaccination of that individual.
measure: Frequency (n, %) for all serious medically attended events and events of interest
timeFrame: Observational period of 1 year following date of vaccination of that individual.
measure: Incidence (n per person years, 95% CI) for all serious medically attended events and events of interest
timeFrame: Observational period of 1 year following date of vaccination of that individual.
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente South California
state: California
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Tartof SY, Sy LS, Ackerson BK, Hechter RC, Haag M, Slezak JM, Luo Y, Fischetti CA, Takhar HS, Miao Y, Solano Z, Jacobsen SJ, Tseng HF. Safety of Quadrivalent Meningococcal Conjugate Vaccine in Children 2-10 Years. Pediatr Infect Dis J. 2017 Nov;36(11):1087-1092. doi: 10.1097/INF.0000000000001696.