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Safety, Tolerability and Immunogenicity of an Inactivated Whole-cell Pneumococcal Vaccine Gamma-PN3.

NCT05667740 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2024-09-05

No results posted yet for this study

Summary

This is a randomised placebo-controlled first-in-man dose-ranging study to determine safety and markers of efficacy.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

Gamma-PN3

Inactivated whole-cell pneumococcal vaccine

BIOLOGICAL

Prevenar-13

Licensed polysaccharide conjugate pneumococcal vaccine

BIOLOGICAL

Pneumovax-23

Licensed polysaccharide pneumococcal vaccine

DRUG

Placebo

Saline

Sponsors & Collaborators

  • GPN Vaccines

    lead INDUSTRY

Principal Investigators

  • Sepehr Shakib, MD · CMAX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2023-10-08
Completion
2023-10-08

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05667740 on ClinicalTrials.gov