Status:

COMPLETED

Extension Safety and Immunogenicity Study of GPNV-001

Lead Sponsor:

GPN Vaccines

Conditions:

Pneumococcal Infections

Eligibility:

All Genders

18-69 years

Phase:

PHASE1

PHASE2

Brief Summary

A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine.

Detailed Description

A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine. Up to 20 participants per cohort will be invited.

Eligibility Criteria

Inclusion

  • Completion of study GPNV-001 as per protocol with no significant deviations.
  • Has provided written informed consent.

Exclusion

  • Potential participants will be excluded if they have received a pneumococcal vaccine since the end of study visit for study GPNV-001
  • A potential participant has had an episode of pneumonia since completing Study GPNV-001

Key Trial Info

Start Date :

July 17 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 30 2024

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05982314

Start Date

July 17 2023

End Date

August 30 2024

Last Update

December 18 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Adelaide

Adelaide, South Australia, Australia, 5005