Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pn-MAPS30plus · 4 trials · 1 indication
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...
Pn-MAPS30plus is an investigational monoclonal antibody being developed for bacterial pneumonia, specifically pneumococcal disease. It is designed to protect against pneumonia caused by Streptococcus pneumoniae. GSK plc is developing the asset, which is currently in Phase 1 clinical development and has not been approved for any use.
Pn-MAPS30plus is developed by GSK plc, which trades under the ticker GSK. GSK is running the clinical program for this investigational monoclonal antibody across adult and pediatric populations, including studies in Australia and South Africa.
Pn-MAPS30plus is in Phase 1 clinical development. Four Phase 1 trials have been registered, three of which are active and one completed, with total enrollment of 354 participants. It is investigational and has not been approved by the FDA or any other regulatory agency.
Registered Phase 1 trials include NCT07428759 in adults aged 50 to 64 in Australia, NCT07406347 in infants receiving a three-dose primary series plus booster, NCT07406334 in toddlers aged 12 to 15 months in South Africa, and the completed NCT07105722 in adults aged 50 to 64 in Australia.
Yes. The Pn-MAPS30plus Phase 1 program uses randomized, double-blind, active-controlled designs. The trials enroll healthy volunteers, including adults aged 50 to 64 and pediatric populations such as infants from 42 days of age and toddlers aged 12 to 15 months.