Serum Collection Study for Assay Development

GPN Vaccines

Status and phase: Enrolling; Phase 1

Conditions: Pneumococcal Disease; Pneumococcal Disease, Invasive

Treatments: Biological: Gamma-PN

Study type: Interventional

Funder types: Industry

Identifiers

NCT07205289

GPNV-008

Details and patient eligibility

About

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

Full 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

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• good general health

Exclusion criteria

• no previous pneumococcal vaccine

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Gamma -PN

Experimental group

Description:

Intramuscular administration 500 mcg

Treatment:

Biological: Gamma-PN