Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07406347 | A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose Primary Dosing Series Followed by a Booster Dose at 12 to 15 Months of Age | PHASE1 | NOT YET_RECRUITING | 60 | — | — | Jul 10, 2026 | Apr 3, 2028 | Feb 12, 2026 | - | — |
| NCT07406334 | 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 | PHASE1 | NOT YET_RECRUITING | 45 | — | — | May 15, 2026 | Feb 22, 2027 | Feb 12, 2026 | - | — |
| NCT07428759 | Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years | PHASE1 | ACTIVE NOT_RECRUITING | 121 | — | — | Mar 10, 2026 | Dec 9, 2026 | May 27, 2026 | 2 | Australia |
| NCT07105722 | A Trial to Evaluate the Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age | PHASE1 | COMPLETED | 127 | — | — | Aug 12, 2025 | May 6, 2026 | Jun 5, 2026 | 4 | Australia |
The AEs considered are tenderness, redness, and swelling.
The AEs considered are fever, irritability, loss of appetite and somnolence (sleepiness/drowsiness).
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.
The solicited systemic AEs considered are fever, headache, fatigue (tiredness), myalgia (muscle pain), and arthralgia (joint pain).
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.
| Arm | Type | Description |
|---|---|---|
| Pn-MAPS30plus Group | EXPERIMENTAL | Participants receive three primary doses of Pn-MAPS30plus on Day 1, Day 61, Day 121 and a booster dose on Day 301. |
| PCV20 Group | ACTIVE_COMPARATOR | Participants receive three primary doses of PCV20 on Day 1, Day 61, Day 121 and a booster dose on Day 301. |
| Group 1: Pn- MAPS30plus | EXPERIMENTAL | Participants receive a single dose of Pn-MAPS30plus vaccine at Day 1. |
| Group 2: PCV20 | ACTIVE_COMPARATOR | Participants receive a single dose of PCV20 (20-valent pneumococcal conjugate vaccine) at Day 1. |
| Name | Type | Description |
|---|---|---|
| Pn-MAPS30plus | BIOLOGICAL | Pn-MAPS30plus vaccine will be administered intramuscularly. |
| PCV20 | COMBINATION_PRODUCT | PCV20 vaccine will be administered intramuscularly. |
Inclusion Criteria: 1. Participants' parent(s)/Legally acceptable representative \[LAR(s)\] who, in the opinion of the investigator, can and will comply with all protocol requirements. 2. Written or witnessed/thumb printed informed consent obtained from the participants' parent(s)/LAR(s) prior to p...