The main purpose of this study is to evaluate safety and reactogenicity of the investigational pneumococcal vaccine (called Pn-MAPS30plus). PCV20 will be used as a comparator for this study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
Pn-MAPS30plus vaccine will be administered intramuscularly.
PCV20 vaccine will be administered intramuscularly.
Number of participants with solicited administration site adverse events (AEs)
The AEs considered are tenderness, redness, and swelling.
Time frame: Day 1 to Day 7
Number of participants with solicited systemic adverse events (AEs)
The AEs considered are fever, irritability, loss of appetite and somnolence (sleepiness/drowsiness).
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 AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal
Time frame: Day 1 up to trial end (Month 16)
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