Safety of MenACWY-CRM Vaccination in Adolescents

A Phase IV Study to Assess the Safety of Menveo Vaccine Being Used by HMO Subjects Aged 11-21 Years of Age

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.

Study Overview

• Status: Completed
• Conditions: Meningococcal Disease
• Intervention / Treatment: Biological: MenACWY-CRM

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.

• Study Type: Observational
• Enrollment (Actual): 55397

Contacts and Locations

Study Locations

• United States
  • California
    • Riverside, California, United States, 92505
      • Riverside Medical Center Campus, 10800 Magnolia Ave
    • San Diego, California, United States, 92120
      • San Diego Medical Center Campus, 4647 Zion Ave 92120
    • Valley Annex, 16994 E. Valley Blvd., Fontana, California, United States, 92335
      • Fontana Medical Center Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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:

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MenACYW-CRM vaccinated adolescents; All adolescent recipients of MenACYW-CRM vaccines during the study period. Among these, adolescents who have additionally experienced an event of interest within the 1-year observation period following vaccination will be included in the self-controlled case series.	Biological: MenACWY-CRM; MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Observational period of 1 year following date of vaccination of that individual.

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency (n,%) of each EOI is calculated.	Observational period of 1 year following date of vaccination of that individual.
Incidence (n/person yrs) of each EOI is calculated.	Observational period of 1 year following date of vaccination of that individual.

Collaborators and Investigators

• Sponsor: Novartis Vaccines
• Collaborators: Novartis

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: October 13, 2011
• First Posted (ESTIMATE): October 14, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 25, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: safety; adolescents; observational; post-marketing; serogroup A, B, Y, W; meningococcal meningitis; meningococcal vaccines; MenACYW-CRM
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: V59_34OB