Serum Collection Study for Assay Development

Not Applicable

Recruiting

• Conditions: Pneumococcal Disease, Invasive; Pneumococcal Disease
• Interventions: Biological: Gamma-PN

• Registration Number: NCT07205289
• Lead Sponsor: GPN Vaccines

Brief Summary

The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation

Detailed Description

The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation

Participants will receive a dose of Gamma-PN and serum will be collected pre dose and Day 28

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-25
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study Start: 2025-10-01
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2026-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• good general health

Exclusion Criteria

• no previous pneumococcal vaccine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gamma -PN	Gamma-PN	Intramuscular administration 500 mcg

Primary Outcome Measures

Name	Time	Method
OPA	6 months	Opsonophagocytic assay

Trial Locations

Locations (1)

University of Adelaide Clinical Research Facility; 🇦🇺 Adelaide, South Australia, Australia