Clinical trial NCT01452464: Safety of MenACWY-CRM Vaccination in Adolescents
Official title: A Phase IV Study to Assess the Safety of Menveo Vaccine Being Used by HMO Subjects Aged 11-21 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
adolescents
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2011-10-14
Enrollment: 55397
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
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 US FDA post-marketing commitment study is to evaluate the safety of MenACWY-CRM among 50.000 vaccinated adolescents within a large US Healthcare Maintenance Organization who received MenACWY-CRM vaccination as part of their routine clinical care. The pre-specified 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: Seizure, Aseptic meningitis, Bell's Palsy, Multiple Sclerosis, Guillain-Barre Syndrome, Acute disseminated encephalomyelitis, Cerebellar ataxia, Transverse myelitis, Brachial Neuritis, Hashimoto's disease, Systemic Lupus Erythematosis, Henoch Schonlein Purpura, New Onset Juvenile 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, Suicide attempt.

Eligibility criteria: Inclusion Criteria:

1. Enrolled in the HMO for at least 6 months prior to vaccination
2. Between the ages of 11 and 21 years (inclusive - i.e. has not reached their 22nd birthday) at the time of the vaccination.
3. Received the vaccine during the study period

Exclusion Criteria:

Primary outcomes:
measure: Relative incidence (RI) for an Event of Interest (EOI) is calculated using the self controlled case series method. RI is the ratio of the incidence of an EOI in a pre-specified, event-specific risk window relative to the incidence in the control period.
timeFrame: Observational period of 1 year following date of vaccination of that individual.
Secondary outcomes:
measure: Frequency (n,%) of each EOI is calculated.
timeFrame: Observational period of 1 year following date of vaccination of that individual.
measure: Incidence (n/person yrs) of each EOI is calculated.
timeFrame: Observational period of 1 year following date of vaccination of that individual.
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Riverside Medical Center Campus, 10800 Magnolia Ave
state: California
city: San Diego
country: United States
facility: San Diego Medical Center Campus, 4647 Zion Ave 92120
state: California
city: Valley Annex, 16994 E. Valley Blvd., Fontana
country: United States
facility: Fontana Medical Center Campus
state: California
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References: