Last updated: 02/18/2020 08:30:06
Meningococcal quadrivalent CRM-197 conjugate vaccine infant study
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
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.
- ▫ children 2-23 months of age at the time of MenACWY-CRM vaccination
- ▫ hold KPSC membership at the time of MenACWY-CRM vaccination
- None
Inclusion and exclusion criteria
Inclusion criteria:
- ▫ 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
Exclusion criteria:
- None
Trial location(s)
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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