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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 pneumococcal vaccine being developed for the prevention of bacterial pneumonia. It is currently in Phase 1 clinical trials evaluating its safety, reactogenicity, and immune response in various age groups, including adults, toddlers, and infants.
Pn-MAPS30plus is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting multiple Phase 1 trials to assess the vaccine's safety and immunogenicity across different populations.
Pn-MAPS30plus is currently in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The ongoing trials are designed to evaluate its safety, reactogenicity, and immune response in adults, toddlers, and infants.
Pn-MAPS30plus is being studied in four Phase 1 trials. NCT07105722 (completed, adults 50-64) and NCT07428759 (active, adults 50-64) evaluate safety and immune response in Australia. NCT07406334 (recruiting, toddlers 12-15 months) and NCT07406347 (not yet recruiting, infants) assess safety and reactogenicity in South Africa.
Pn-MAPS30plus is a monoclonal antibody-based pneumococcal vaccine designed to elicit an immune response against bacterial pneumonia. The specific molecular target has not been disclosed, but the vaccine aims to generate protective immunity against pneumococcal infection.
Pn-MAPS30plus is a distinct investigational vaccine candidate developed by GSK. It is not identified as being the same as any other marketed pneumococcal vaccine. Its unique formulation and mechanism are under evaluation in early-stage clinical trials.