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

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.

Study Overview

• Status: Completed
• Conditions: Meningococcal Disease
• Intervention / Treatment: Biological: MenACWY-CRM

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

• Study Type: Observational
• Enrollment (Actual): 393

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91101
      • Kaiser Permanente South California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is selected from the Health Maintenance Organization population of the Kaiser Permanente Southern California (KPSC) HMO in Pasadena, CA, USA.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: MenACWY-CRM; MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records.

What is the study measuring?

Primary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Publications and helpful links

General Publications

• Tartof SY, Sy LS, Ackerson BK, Hechter RC, Haag M, Slezak JM, Luo Y, Fischetti CA, Takhar HS, Miao Y, Solano Z, Jacobsen SJ, Tseng HF. Safety of Quadrivalent Meningococcal Conjugate Vaccine in Children 2-10 Years. Pediatr Infect Dis J. 2017 Nov;36(11):1087-1092. doi: 10.1097/INF.0000000000001696.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (Estimate): October 14, 2011

Study Record Updates

• Last Update Posted (Estimate): August 6, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: safety; children; observational; post-marketing; serogroup A, B, Y, W; meningococcal meningitis; meningococcal vaccines; MenACYW-CRM
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: V59_54OB