Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults

EuBiologics

Status and phase: Completed; Phase 1

Conditions: Pneumococcal Disease

Treatments: Biological: Prevenar13; Biological: EuPCV15

Study type: Interventional

Funder types: Industry

Identifiers

NCT04830358

EuVCT_PCV101

Details and patient eligibility

About

The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.

Enrollment: 60 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adults aged 19 to 50 years old
2. Participants willing to give written informed consent to participate in the trial

Exclusion criteria

1. History of invasive pneumococcal infection within 5 years at screening
2. Known hypersensitivity to any component of the study vaccine
3. Immune deficiency or immunosuppressive disorder
4. Immunized with any licensed vaccine within 4 weeks prior to screening
5. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
6. Participants who in the opinion of the investigator will not be able to comply with any of the protocol required procedure

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

EuPCV15

Experimental group

Description:

Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0.

Treatment:

Biological: EuPCV15

Prevenar13

Active Comparator group

Description:

Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0.

Treatment:

Biological: Prevenar13