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

NCT ID: NCT04830358

Last Updated: 2021-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-28

Study Completion Date

2021-02-01

Brief Summary

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

Detailed Description

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Conditions

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Pneumococcal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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EuPCV15

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

Group Type EXPERIMENTAL

EuPCV15

Intervention Type BIOLOGICAL

15-valent Pneumococcal conjugate vaccine

Prevenar13

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

Group Type ACTIVE_COMPARATOR

Prevenar13

Intervention Type BIOLOGICAL

13-valent Pneumococcal conjugate vaccine

Interventions

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EuPCV15

15-valent Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Prevenar13

13-valent Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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EuBiologics Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Catholic University of Seoul St.Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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EuVCT_PCV101

Identifier Type: -

Identifier Source: org_study_id

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