In short
PF-07872444 is an investigational pneumococcal vaccine being studied for protection against pneumococcal disease. It is being tested in two Phase 3 trials with a total of 3,600 healthy infants, children and adolescents. The trials compare PF-07872444 with Prevenar 20, a licensed 20-valent pneumococcal conjugate vaccine. Both studies are authorised but not yet recruiting.
Key points
- PF-07872444 is an investigational pneumococcal vaccine given by intramuscular injection.
- It is being studied in two Phase 3 trials with a combined enrolment of 3,600 participants.
- The trials include healthy infants and healthy children and adolescents aged up to 18 years.
- Both studies compare PF-07872444 with Prevenar 20, a licensed pneumococcal vaccine.
- Main outcomes include injection site reactions, systemic events and immune responses.
- Both trials are currently authorised.
What is PF-07872444?
PF-07872444 is an investigational pneumococcal vaccine. It is being developed to protect against infections caused by the bacterium Streptococcus pneumoniae, also known as pneumococcus. The vaccine is given as a 0.5 ml suspension for injection by the intramuscular route. PF-07872444 has no marketing authorisation in these records and is still being studied in clinical trials.
How does PF-07872444 work?
PF-07872444 is a pneumococcal polysaccharide conjugate vaccine. Conjugate vaccines link polysaccharides (sugars from the bacterial surface) to a carrier protein. This helps the immune system recognise the bacteria and produce antibodies. The trial records describe PF-07872444 as a pneumococcal vaccine studied alongside Prevenar 20, a 20-valent pneumococcal polysaccharide conjugate vaccine. The exact number of pneumococcal serotypes covered by PF-07872444 is not stated in the registry records.
Which conditions is it used or studied for?
- Pneumococcal immunisation — both trials study PF-07872444 for immunisation against pneumococcal disease in healthy infants, children and adolescents.
How is PF-07872444 given?
PF-07872444 is given as a 0.5 ml suspension for injection by the intramuscular route. In the trials, the comparator Prevenar 20 is supplied in a pre-filled syringe as a 0.5 ml intramuscular injection.
What do the clinical trials show?
Two Phase 3 trials of PF-07872444 are registered. Both are authorised but not yet recruiting. Trial C4931007 plans to enrol 2,400 healthy infants to describe the safety profile of the PG4 vaccine. Trial C4931004 plans to enrol 1,200 healthy children and adolescents to describe safety, tolerability and the immune response generated by the vaccine.
What are the trials measuring?
Both trials measure prespecified local reactions at the injection site: redness, swelling and pain. They also measure systemic events. In the infant trial these include fever, decreased appetite, irritability and drowsiness or increased sleep. In the children and adolescents trial, systemic events include fever, fatigue, headache, muscle pain and joint pain, with age-specific differences for children aged 15 to under 24 months. Adverse events and serious adverse events are recorded in both trials. The children and adolescents trial also measures pneumococcal serotype-specific IgG concentrations (antibody levels in the blood) and OPA titers (opsonophagocytic activity, a measure of how well antibodies help immune cells destroy bacteria).
Who can take part in these trials?
Trial C4931007 enrols healthy infants. Trial C4931004 enrols healthy children and adolescents in three cohorts: 15 to under 24 months, 2 to under 18 years, and a further age group described as cohort 2 and 3 for participants aged 2 to under 18 years. Both trials compare PF-07872444 with Prevenar 20.
What side effects are known?
The registry records do not report side effects observed in completed studies. The trials are designed to collect information on local reactions, systemic events, adverse events and serious adverse events, but no results are available yet.