Serum Collection Study for Assay Development
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gamma-PN.
- Who it may be relevant to
- Registry conditions: Pneumococcal Disease, Invasive, Pneumococcal Disease. Basic parameters: 18 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1B Open-label Study to Collect Serum Following Vaccination With Killed Whole-cell Pneumococcal Vaccine (Gamma-PN) in Adults for Use in Assay Validation
Overview
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
Interventions
- Biological Gamma-PN
Killed whole-cell pneumococcal vaccine
Primary outcome measures
- OPA [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- good general health
Exclusion criteria
- no previous pneumococcal vaccine
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Australia · 1 center
- University of Adelaide Clinical Research Facility — Adelaide
Identifiers
NCT: NCT07205289 · GPNV-008