Safety Surveillance of MenACWY-CRM Vaccine in Children

NCT01452438 | Completed

• 1 other identifier: V59_54OB
• Study Type: observational
• Target: 393
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningococcal Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

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

Interventions

MenACWY-CRM BIOLOGICAL

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

MenACYW-CRM vaccinated children

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

Kaiser Permanente South California

Pasadena, California, 91101, United States

Location

Related Publications (1)

• 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.

  PMID: 28719502 DERIVED

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal

Interventions

MenACWY-CRM vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 14, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

US (1)