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OpenTrials
Completed

NCT Number: NCT01452464

Safety of MenACWY-CRM Vaccination in Adolescents

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.

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Key information

Conditions

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

Age range

11 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Riverside Medical Center Campus, 10800 Magnolia Ave, Riverside, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

Treatment and study plan

MenACWY-CRM

Biological

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

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.

    Time frame: Observational period of 1 year following date of vaccination of that individual.

Secondary outcomes

  1. Frequency (n,%) of each EOI is calculated.

    Time frame: Observational period of 1 year following date of vaccination of that individual.

  2. Incidence (n/person yrs) of each EOI is calculated.

    Time frame: Observational period of 1 year following date of vaccination of that individual.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 14, 2011
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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