A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in T… (NCT07406334) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months of Age Receiving a Single Booster Dose
45 participantsStarted 2026-05-15
Plain-language summary
The main purpose of this study is to assess the safety and reactogenicity of a single dose of the new pneumococcal vaccine (called Pn-MAPS30plus) in toddlers who have previously completed a two-dose primary vaccination series with PCV used in local immunization program. PCV20 will be used as a comparator for this study.
Who can participate
Age range12 Months – 15 Months
SexALL
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Inclusion criteria
✓. 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 any study-specific procedure is performed.
✓. A male or female between, and including, 12 to15 Months of age at the time of the study intervention administration.
✓. Healthy participants or medically stable patients as established by medical history and clinical examination before entering the study.
✓. To the best knowledge of the participant's parent(s)/LAR(s), the child has been eligible for pneumococcal vaccination and has completed a 2-dose primary series with PCV10.
Exclusion criteria
✕. 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.
✕. Major congenital defects, as assessed by the investigator.
✕. Recurrent history or uncontrolled neurological disorders or any neuroinflammatory condition, congenital neurological conditions, encephalopathies, or seizures.
What they're measuring
1
Number of Participants with Solicited Administration site Adverse Events (AEs)
Timeframe: Day 1 to Day 7
2
Number of Participants with Solicited Systemic Adverse Events (AEs)
Timeframe: Day 1 to Day 7
3
Number of Participants with Unsolicited AEs
Timeframe: Day 1 to Day 30
4
Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal
Timeframe: Day 1 up to trial end (Month 6)
5
Number of Participants with Hematological and Biochemical Laboratory Abnormalities
Timeframe: On Day 8 compared to Day 1 (pre-vaccination)
✕. Condition that in the judgment of the investigator would make intramuscular injection unsafe.
✕. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.