Safety of MenACWY-CRM Vaccination in Adolescents

NCT01452464 | Completed

• 1 other identifier: V59_34OB
• Study Type: observational
• Target: 55,397
• Locations: 1 country
• Sites: 3

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.

Conditions

Meningococcal Disease

Keywords

observational; serogroup A, B, Y, W; meningococcal meningitis; meningococcal vaccines; safety; MenACYW-CRM; post-marketing; adolescents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (1)

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

Interventions

MenACWY-CRM BIOLOGICAL

MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records.

MenACYW-CRM vaccinated adolescents

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Novartis Vaccines: lead
• Novartis: collaborator

Study Sites (3)

Riverside Medical Center Campus, 10800 Magnolia Ave

Riverside, California, 92505, United States

Location

San Diego Medical Center Campus, 4647 Zion Ave 92120

San Diego, California, 92120, United States

Location

Fontana Medical Center Campus

Valley Annex, 16994 E. Valley Blvd., Fontana, California, 92335, United States

Location

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal

Interventions

MenACWY-CRM vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 14, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 26, 2015

Record last verified: 2015-02

Locations

US (3)