About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants' parent(s)/Legally acceptable representative [LAR(s)] who, in the opinion of the investigator, can and will comply with all protocol requirements.
Written or witnessed/thumb printed informed consent obtained from the participants' parent(s)/LAR(s) prior to performance of any study-specific procedure.
Participant is approximately 2 Months of Age [MOA (42 to 90 days, inclusive)] at time of first study intervention administration.
Healthy participants as established by medical history and clinical examination before entering the trial.
Disqualifiers
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
Hypersensitivity to latex.
History of microbiologically proven Invasive pneumococcal Disease (IPD).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Trial design
Parallel
Treatments tested in this trial
Pn-MAPS30plus
Biological/VaccinePn-MAPS30plus vaccine will be administered intramuscularly.
PCV20
Combination productPCV20 vaccine will be administered intramuscularly.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with solicited administration site adverse events (AEs)
The AEs considered are tenderness, redness, and swelling.
Number of participants with solicited systemic adverse events (AEs)
The AEs considered are fever, irritability, loss of appetite and somnolence (sleepiness/drowsiness).
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.
Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: