Safety Surveillance of MenACWY-CRM Vaccine in Children

Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (Menveo) Vaccination in Children 2 Through 10 Years of Age

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01452438

Enrollment

393

Registered

2011-10-14

Start date

2011-09-30

Completion date

2015-07-31

Last updated

2015-08-06

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, children

Brief summary

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.

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: 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

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

2 Years to 10 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Timing relative to vaccination date (mean days (SD)) for all serious medically attended events and events of interest	Observational period of 1 year following date of vaccination of that individual.
Frequency (n, %) for all serious medically attended events and events of interest	Observational period of 1 year following date of vaccination of that individual.
Incidence (n per person years, 95% CI) for all serious medically attended events and events of interest	Observational period of 1 year following date of vaccination of that individual.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026