In short
PF-07872419 is an investigational pneumococcal vaccine being studied for pneumococcal immunisation. It is being evaluated in two authorised Phase 3 trials with a combined enrollment of 3,600 healthy infants, children, and adolescents. The trials compare the safety and immune response of PF-07872419 with Prevenar 20, an existing 20-valent pneumococcal conjugate vaccine.
PF-07872419 is an investigational pneumococcal vaccine being developed and studied for pneumococcal immunisation. The substance is referred to in trial records as PF-07872412 in the intervention descriptions. It is given as a 0.5 ml injection into the muscle (intramuscular).
Key points
- PF-07872419 is an investigational pneumococcal vaccine studied in two Phase 3 trials.
- The trials include 3,600 healthy participants: 2,400 infants and 1,200 children and adolescents.
- Both trials are authorised in the EU Clinical Trials Information System.
- The studies measure safety, including local reactions, systemic events, and serious adverse events.
- One trial also measures immune response through pneumococcal serotype-specific IgG concentrations and OPA titers.
- PF-07872419 is given as a 0.5 ml intramuscular injection.
What is PF-07872419?
PF-07872419 is an investigational pneumococcal vaccine. It appears in the EU Clinical Trials Information System under the trial records C4931007 and C4931004. In the intervention lists of these trials, the substance is named PF-07872412 and is given as a 0.5 ml intramuscular injection. The trials describe it as a new pneumococcal vaccine, referred to as the PG4 vaccine in the brief summaries. No marketing authorisation is mentioned in these records, and the substance is being studied in comparison with Prevenar 20, an authorised 20-valent pneumococcal polysaccharide conjugate vaccine.
How does PF-07872419 work?
The trial records do not describe the mechanism of action of PF-07872419 in detail. As a pneumococcal vaccine, it is studied for pneumococcal immunisation, which means it is intended to help the body develop protection against pneumococcal bacteria. The trials compare it with Prevenar 20, a pneumococcal polysaccharide conjugate vaccine that contains 20 pneumococcal serotypes. One of the two trials measures immune responses by looking at pneumococcal serotype-specific IgG concentrations in the blood and pneumococcal serotype-specific OPA titers, which reflect the ability of antibodies to kill pneumococcal bacteria.
Which conditions is PF-07872419 used or studied for?
PF-07872419 is studied for one condition:
- Pneumococcal immunisation — protection against infections caused by the bacterium Streptococcus pneumoniae, which can lead to pneumonia, meningitis, and bloodstream infections.
How is PF-07872419 given?
In both trials, PF-07872419 is given as a 0.5 ml injection into the muscle (intramuscular). The comparator vaccine, Prevenar 20, is a suspension for injection in a pre-filled syringe and is also given intramuscularly.
What do the clinical trials show?
Two authorised Phase 3 trials are registered for PF-07872419. Both are interventional studies in pneumococcal immunisation.
Who can take part in these trials?
One trial, C4931007, enrolls 2,400 healthy infants. The other, C4931004, enrolls 1,200 healthy children and adolescents, divided into cohorts by age: 15 to less than 24 months, 2 to less than 18 years, and another cohort within that range.
What are the trials measuring?
Both trials measure prespecified local reactions at the injection site, including redness, swelling, and pain. They also record prespecified systemic events such as fever, decreased appetite, drowsiness or increased sleep, and irritability. In the trial with older children and adolescents, systemic events also include fatigue, headache, muscle pain, and joint pain. Both trials record adverse events and serious adverse events. The trial in children and adolescents additionally measures pneumococcal serotype-specific IgG concentrations and pneumococcal serotype-specific OPA titers to assess the immune response generated by the vaccine.
What status are the trials in?
Both trials are authorised in the EU Clinical Trials Information System. Trial C4931007 has 2,400 participants and trial C4931004 has 1,200 participants.