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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
121
Single dose of Pn-MAPS30plus received intramuscularly.
Single dose of PCV20 received intramuscularly.
GSK Investigational Site
Norwood, South Australia, Australia
GSK Investigational Site
Camberwell, Victoria, Australia
Number of Participants with Solicited Administration Site Adverse Events (AEs)
The solicited administration site AEs considered are pain, redness and swelling.
Time frame: Day 1 to Day 7
Number of Participants with Solicited Systemic AEs
The solicited systemic AEs considered are fever, headache, fatigue (tiredness), myalgia (muscle pain), and arthralgia (joint pain).
Time frame: Day 1 to Day 7
Number of Participants with Unsolicited AEs
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.
Time frame: Day 1 to Day 30
Number of Participants with Serious Adverse Events (SAEs)
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.
Time frame: From Day 1 to Day 181 (study end)
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: From Day 1 to Day 181 (study end)
Number of Participants with AEs Leading to withdrawal from the study
Time frame: From Day 1 to Day 181 (study end)
Number of Participants with any Laboratory abnormalities
Time frame: Day 8 compared to Screening Visit (up to Day -14)
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