In short
PF-07872445 is an investigational pneumococcal vaccine being studied for protection against pneumococcal disease. It is being evaluated in two Phase 3 clinical trials involving a total of 3,600 healthy infants, children and adolescents. The trials compare the safety and immune response of PF-07872445 with Prevenar 20, an authorised 20-valent pneumococcal conjugate vaccine.
Key points
- PF-07872445 is an investigational pneumococcal vaccine being developed for pneumococcal immunisation.
- Two Phase 3 trials are currently authorised, together planning to enrol 3,600 participants.
- One trial focuses on healthy infants and the other on healthy children and adolescents.
- The studies measure injection site reactions, systemic events, and immune responses such as antibody levels.
- Both trials use Prevenar 20 as the comparison vaccine.
What is PF-07872445?
PF-07872445 is an investigational pneumococcal vaccine. It is being studied in clinical trials for pneumococcal immunisation, which means protection against infections caused by the bacterium Streptococcus pneumoniae. The substance is administered as a suspension for injection given intramuscularly. In the trial records, PF-07872445 appears alongside Prevenar 20, a 20-valent pneumococcal polysaccharide conjugate vaccine that is already authorised and serves as the comparison in these studies.
How does PF-07872445 work?
Pneumococcal conjugate vaccines work by presenting fragments of the polysaccharide capsule from multiple pneumococcal serotypes to the immune system, linked to a carrier protein. This helps the body produce antibodies and immune memory against those serotypes. In the authorised trials, the primary outcomes include measuring pneumococcal serotype-specific IgG concentrations and opsonophagocytic activity (OPA) titers, which are laboratory measures of how well antibodies can help immune cells eliminate pneumococcal bacteria. The trial records do not provide further detail on the exact number of serotypes covered by PF-07872445.
Which conditions is it studied for?
- Pneumococcal immunisation in healthy infants — one Phase 3 trial is enrolling 2,400 healthy infants to study the safety of the vaccine.
- Pneumococcal immunisation in healthy children and adolescents — a second Phase 3 trial is enrolling 1,200 healthy children and adolescents to study both safety and the immune response generated by the vaccine.
How is PF-07872445 given?
PF-07872445 is given as an intramuscular injection. The trial records list a 0.5 ml dose administered intramuscularly, the same volume and route used for Prevenar 20 in the comparison arms. The pharmaceutical form is a suspension for injection.
What do the clinical trials show?
Two Phase 3 trials of PF-07872445 are authorised in the EU Clinical Trials Information System. Both are interventional studies in pneumococcal immunisation. The first trial, C4931007, is a safety study in 2,400 healthy infants. The second trial, C4931004, studies safety and immune response in 1,200 healthy children and adolescents.
The primary outcomes measured in the infant trial are prespecified local reactions such as redness, swelling and pain at the injection site, prespecified systemic events including fever, decreased appetite, irritability and drowsiness, as well as adverse events and serious adverse events. The children and adolescents trial measures similar local and systemic events, adjusted by age group, and additionally measures pneumococcal serotype-specific IgG concentrations and OPA titers to assess the immune response.
Both trials are currently authorised, meaning they have received regulatory approval to begin, but no results have been reported in the registry records. The comparison vaccine in all arms is Prevenar 20, an authorised 20-valent pneumococcal conjugate vaccine.
What side effects are known?
The trial records do not provide results on side effects, as the studies are authorised but have not reported outcomes. The primary outcomes being measured include local reactions at the injection site such as redness, swelling and pain, and systemic events such as fever, decreased appetite, irritability, drowsiness, fatigue, headache, muscle pain and joint pain. These are the events the trials are designed to detect and assess.