NCT04830358

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
Last Updated

October 7, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 31, 2021

Last Update Submit

October 6, 2021

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (3)

  • Incidence of Solicited AEs (Local and Systemic)

    within 14 days after vaccination

  • Incidence of Unsolicited AEs

    within 28 days after vaccination

  • Incidence of SAEs

    within 180 days after vaccination

Study Arms (2)

EuPCV15

EXPERIMENTAL

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

Biological: EuPCV15

Prevenar13

ACTIVE COMPARATOR

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

Biological: Prevenar13

Interventions

EuPCV15BIOLOGICAL

15-valent Pneumococcal conjugate vaccine

EuPCV15
Prevenar13BIOLOGICAL

13-valent Pneumococcal conjugate vaccine

Prevenar13

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Seoul St.Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

May 28, 2020

Primary Completion

August 14, 2020

Study Completion

February 1, 2021

Last Updated

October 7, 2021

Record last verified: 2021-03

Locations

KR(1)