Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

NCT02287688 | Completed Results

• 2 other identifiers: 205534V59_74OB
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This safety surveillance study of GlaxoSmithKline's quadrivalent meningococcal ACWY conjugate vaccine (Meningococcal quadrivalent CRM-197) among children 2 months through 23 months of age is a post-marketing study required by the United States Food and Drug Administration. It is an observational study of children 2-23 months of age who receive at least one dose of MenACWY-CRM vaccine at a Kaiser Permanente Southern California facility (KPSC) while enrolled as a KPSC health plan member. The objective of the infant study is to describe medical events that require emergency room visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23 months of age in a health maintenance organization in the United States. Outcomes include medical events that require emergency room visits or hospitalizations in children 2-23 months of age following any dose of MenACWY-CRM vaccination. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination will be excluded as a pre-existing condition.

Conditions

Meningococcal Disease; Infections, Meningococcal

Keywords

safety of Meningococcal quadrivalent CRM-197 conjugate vaccine; Children 2-23 months of age

Outcome Measures

Primary Outcomes (6)

• Number of Subjects Who Experienced Single or Multiple Medical Encounters

  The number of subjects who experienced single or multiple encounters of medical events resulting in Emergency Department (ED) or hospitalization visits were reported

  Within 6 months after any dose of MenACWY-CRM vaccination

• Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination

  All medical encounters that required ED visits and hospitalizations within 6 months of vaccination were assessed. Medical encounters were considered pre-existing if all diagnoses made during an ED and/or hospitalization were pre-existing. If a study subject was first seen in the ED and subsequently transferred to the hospital, this was treated as a single episode of care.

  Within 6 months after any dose of MenACWY-CRM

• Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination

  The incidence rate of medical encounters was defined as the number of all captured encounters divided by the total person-time following MenACWY-CRM doses administered during the study period. The rate and Poisson 95% CI of medical encounters were calculated and presented as number per person-year. Person-time for each dose began at the date of the vaccination and ended at 6 months following vaccination, disenrollment, death, the end of data collection, or receipt of an additional dose of MenACWY-CRM, whichever came first.

  Within 6 months after any dose of MenACWY-CRM

• Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses

  Number of subjects who experienced single or multiple medical diagnoses after the MenACWY-CRM dose were reported

  Within 6 months after any dose of MenACWY-CRM

• Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination

  All medical diagnoses that required ED or hospitalization visits within 6 months of vaccination were assessed. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination were excluded as pre-existing conditions. Data presented for this outcome measure includes all medical diagnoses after the first and recurrent diagnoses. Diagnoses were identified from Electronic Medical Records (EMRs) of emergency and hospital care encounters by automated algorithm identification and then were manually reviewed by a physician to determine the final diagnosis/ diagnoses and diagnosis dates for the encounter. Diagnoses were classified according to International Classification of Diseases, ninth revision (ICD-9) codification. All medical diagnoses assessed are presented in short forms with the ICD code, due to character limitations.

  Within 6 months after any dose of MenACWY-CRM

• Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination

  The incidence rate of diagnoses was defined as the number of all captured diagnoses divided by the total person-time following MenACWY-CRM doses administered during the study period. The rate and Poisson 95% CI of medical diagnoses were calculated and presented as number per person-year.Person-time for each dose began at the date of the vaccination and ended at 6 months following vaccination, disenrollment, death, the end of data collection, or receipt of an additional dose of MenACWY-CRM, whichever came first. Diagnoses were classified according ICD-9 codification. All medical diagnoses assessed are presented in short forms with the ICD code, due to character limitations.

  Within 6 months after any dose of MenACWY-CRM

Study Arms (1)

Exposure group

Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.

Biological: Meningococcal quadrivalent CRM-197 conjugate vaccine

Interventions

Meningococcal quadrivalent CRM-197 conjugate vaccine BIOLOGICAL

This study is strictly observational. Decisions of vaccination are made by health care providers.

Exposure group

Eligibility Criteria

• Age: 2 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children 2-23 months of age who receive at least one dose of MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.

You may qualify if:

• children 2-23 months of age at the time of MenACWY-CRM vaccination
• hold KPSC membership at the time of MenACWY-CRM vaccination
• vaccinated with MenACWY-CRM during the study period in KPSC

You may not qualify if:

• None

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Pasadena, California, 91101, United States

Location

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 11, 2014
• Study Start: December 1, 2014
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: October 21, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-10

Locations

US (1)