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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01452464

Enrollment

55397

Registered

2011-10-14

Start date

2011-09-30

Completion date

2015-02-28

Last updated

2015-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Disease

Keywords

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

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.

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.

Interventions

BIOLOGICALMenACWY-CRM

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

11 Years to 21 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026