Last updated: 02/18/2020 08:30:06

Meningococcal quadrivalent CRM-197 conjugate vaccine infant study

GSK study ID
205534
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Post-licensure observational safety surveillance study of quadrivalent meningococcal ACWY conjugate vaccine MenACWY-CRM (MENVEO®) in children 2 months through 23 months of age.
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects who experienced single or multiple medical encounters

Timeframe: Within 6 months after any dose of MenACWY-CRM vaccination

Number of medical encounters following any dose of MenACWY-CRM vaccination

Timeframe: Within 6 months after any dose of MenACWY-CRM

Incidence rate of medical encounters following any dose of MenACWY-CRM vaccination

Timeframe: Within 6 months after any dose of MenACWY-CRM

Number of subjects who experienced single or mutiple medical diagnoses

Timeframe: Within 6 months after any dose of MenACWY-CRM

Number of medical diagnoses following any dose of MenACWY-CRM vaccination

Timeframe: Within 6 months after any dose of MenACWY-CRM

Incidence rate of medical diagnoses following any dose of MenACWY- CRM vaccination

Timeframe: Within 6 months after any dose of MenACWY-CRM

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Meningococcal quadrivalent CRM-197 conjugate vaccine
  • Enrollment:
    144
    Primary completion date:
    2017-29-11
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Tracy A Becerra-Culqui, Lina S. Sy, Bradley K Ackerson, Jeff M. Slezak, Yi Luo, Christine A. Fischetti, Yvonne U. Ohadike, Carlo Curina, Michele Pellegrini, Zendi Solano, Sara Y. Tartof, Hung Fu Tseng. Safety of Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers 2 to 23-months old. Vaccine. 2020. 38(2):228-234.
    Medical condition
    Meningococcal disease
    Product
    GSK3536820A
    Collaborators
    Not applicable
    Study date(s)
    December 2014 to November 2017
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    2 - 23 months
    Accepts healthy volunteers
    No
    • ▫ children 2-23 months of age at the time of MenACWY-CRM vaccination
    • ▫ hold KPSC membership at the time of MenACWY-CRM vaccination
    • None

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Pasadena, California, United States, 91101
    Status
    Study Complete

    Study documents

    Statistical analysis plan
    Available language(s): English
    Protocol
    Available language(s): English
    Clinical study report
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2017-29-11
    Actual study completion date
    2017-29-11

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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