Safety and Immunogenicity of Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old

NCT04714229 — Phase 1, Completed, 60 participants, EuBiologics Co.,Ltd

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A Single Center, Randomized, Observer-blinded, Active Comparator Phase I Study to Assess the Safety and Immunogenicity of Meningococcal (Groups A, C, W-135 and Y) Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old

Registry	NCT04714229
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: triple, prevention
Enrollment	60 (Actual)
Sponsor	EuBiologics Co.,Ltd (Industry)
Conditions	Infection, Meningococcal
Interventions	Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine, Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine (Biological)
Dates	start 2020-09-01, primary completion 2020-11-01, completion 2021-09-01, first posted 2021-01-19, last updated 2021-10-07
Locations	1 site in South Korea

-Summary

Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, and Y)-CRM197 Conjugate vaccine

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+Arms and interventions

Arm	Type	Interventions	Description
EuMCV4	Experimental	Biological: Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine	Healthy adults received 0.5mL single intramuscular dose on Day 0.
Menveo	Active comparator	Biological: Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine	Healthy adults received 0.5mL single intramuscular dose on Day 0.

Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine (Biological), also known as EuMCV4: 0.5mL single intramuscular dose on Day 0
Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine (Biological), also known as Menveo: 0.5mL single intramuscular dose on Day 0

+Outcome measures

Primary outcomes

Occurrence of solicited adverse events [within 7 days post vaccination]: local and systemic AEs
Occurrence of unsolicited adverse events [within 28 days post vaccination]
Occurrence of serious adverse events [within 180 days post vaccination]

+Eligibility

Sex: All, ages: 19 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* Subjects 19 to 55 years of age
* Written informed consent
* Available for all visits and telephone calls scheduled for the study

Exclusion Criteria:

* Previous or suspected disease caused by N. meningitidis
* Household and/or intimate exposure to an individual with culture-proven N. meinigitidis infection within 60 days prior to screening
* Serious acute, chronic or progressive disease as determined by investigator
* History of alcohol or substance abuse

+Locations (1)

Facility	City	Country	Status
Seoul National University Hospital	Seoul	South Korea

+Investigators

YJ Lee, Study director, EuBiologics Co.,Ltd

My Notes

Public

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