Safety Surveillance of MenACWY-CRM Vaccine in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

393 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety of MenACWY-CRM Vaccination in Adolescents

NCT01452464

Meningococcal Disease

COMPLETED

Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

NCT02287688

Meningococcal Disease Infections, Meningococcal

COMPLETED

Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.

NCT01682876

Meningococcal Disease Infections, Meningococcal

COMPLETED PHASE3

Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers

NCT01994629

Meningococcal Disease

COMPLETED PHASE2

Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers

NCT00626327

Meningococcal Infections

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meningococcal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MenACYW-CRM vaccinated children

All children between the age of 2 to 10 years old who have received of MenACYW-CRM vaccine during the study period.

MenACWY-CRM

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MenACWY-CRM

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.