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Completed

NCT Number: NCT01452438

Safety Surveillance of MenACWY-CRM Vaccine in Children

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.

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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

2 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente South California

Pasadena, California, 91101, United States

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: 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

Who can participate

Healthy volunteers accepted: Yes

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

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

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. Timing relative to vaccination date (mean days (SD)) for all serious medically attended events and events of interest

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

  2. Frequency (n, %) for all serious medically attended events and events of interest

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

  3. Incidence (n per person years, 95% CI) for all serious medically attended events and events of interest

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

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 14, 2011
Registry last updated
Aug 6, 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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