Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Condition(s) studied
Investigational drug(s) / intervention(s)
Pn-MAPS30plus: Single dose of Pn-MAPS30plus received intramuscularly.
PCV20: Single dose of PCV20 received intramuscularly.
Study summary
This study will evaluate the safety and immune response of a new formulation of pneumococcal vaccine, PnMAPS30plus, in healthy adults aged 50 to 64 years. Participants will receive a single dose of either the investigational vaccine or an approved pneumococcal vaccine (PCV20) and will be monitored for approximately six months. The study aims to determine if PnMAPS30plus is safe and well-tolerated and whether it helps the body produce antibodies that protect against pneumococcal disease.
Eligibility
Primary outcome measure(s)
- Number of Participants with Solicited Administration Site Adverse Events (AEs) — Day 1 to Day 7
The solicited administration site AEs considered are pain, redness and swelling. - Number of Participants with Solicited Systemic AEs — Day 1 to Day 7
The solicited systemic AEs considered are fever, headache, fatigue (tiredness), myalgia (muscle pain), and arthralgia (joint pain). - Number of Participants with Unsolicited AEs — Day 1 to Day 30
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. - Number of Participants with Serious Adverse Events (SAEs) — From Day 1 to Day 181 (study end)
SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment. - Number of Participants with Adverse Events of Special Interest (AESIs) — From Day 1 to Day 181 (study end)
- Number of Participants with AEs Leading to withdrawal from the study — From Day 1 to Day 181 (study end)
- Number of Participants with any Laboratory abnormalities — Day 8 compared to Screening Visit (up to Day -14)
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Norwood | South Australia | |
| GSK Investigational Site | Camberwell | Victoria |
More GlaxoSmithKline trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07428759 on ClinicalTrials.gov ↗ ← All trials in Australia