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Safety and immune response of PF-07872412 compared with 20-valent pneumococcal conjugate vaccine for pneumococcal disease in healthy children and adolescents

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on pneumococcal disease, an infection caused by bacteria that can lead to pneumonia, ear infections, and meningitis. It evaluates a new multivalent pneumococcal conjugate vaccine, referred to as the PG4 vaccine, which is designed to protect against many different strains of the bacteria. For comparison, an already approved vaccine called Prevenar 20 is also used in the trial.

The main aim of the trial is to describe the safety and tolerability of the PG4 vaccine in healthy children and adolescents. Participants will receive a single injection in the muscle and will be observed for any local reactions such as redness, swelling, or pain at the injection site, as well as systemic events like fever, fatigue, headache, muscle or joint pain, and changes in appetite or sleep. Blood samples will be taken to measure specific immune responses, including the amount of antibodies (IgG) and the ability of those antibodies to kill the bacteria, which is assessed by a test called OPA.

After the injection, participants will be followed for several weeks with scheduled visits and phone contacts to record any adverse events and to collect blood for laboratory analysis. The study is double‑blind, meaning neither the participants nor the investigators know which vaccine was given, to ensure unbiased assessment of safety and immune response.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial vaccination visit
You will receive a single injection of the study vaccine. the injection is given into the muscle of the upper arm and contains 0.5 ml of the product. depending on random assignment, the product will be either the investigational vaccine pf‑07872412 or the comparator vaccine prevenar 20. both vaccines contain the same set of pneumococcal polysaccharide antigens linked to a carrier protein.
The injection is administered using a sterile pre‑filled syringe. no other medication is taken at this visit.
Step 2
Immediate observation
After the injection you will remain in the clinic for a short observation period, typically about fifteen to thirty minutes, so that staff can watch for any immediate reactions such as redness, swelling, pain, or signs of an allergic response.
Step 3
Recording local and systemic reactions
You will be given a diary to record any symptoms that occur after vaccination. for all ages, note any redness, swelling, or pain at the injection site. for children aged fifteen to less than twenty‑four months, also record fever, decreased appetite, increased sleepiness, and irritability. for participants aged two years to less than eighteen years, record fever, fatigue, headache, muscle pain, and joint pain.
Each term is explained in plain language: fever means a temperature higher than normal; fatigue is feeling unusually tired; headache is pain in the head; muscle pain and joint pain refer to soreness in muscles or joints.
Step 4
Follow‑up safety visits and blood sampling
You will return to the study site on dates scheduled by the study team for safety assessments. during these visits staff will ask about any adverse events or serious adverse events that have occurred since the last visit.
Blood samples will be taken to measure pneumococcal serotype‑specific igg concentrations and opa titers, which indicate the immune response generated by the vaccine.
Step 5
Final study completion
After the last scheduled visit and final laboratory assessments, the study participation ends. no further study‑specific procedures are required.

Who can join the trial?

5 criteria

Be in one of the age groups defined for the study: at least 15 months old but younger than 2 years, or at least 2 years old but younger than 5 years, or at least 5 years old but younger than 18 years at the time you sign the permission form. These groups are called cohorts.
Be a healthy child, as judged by the doctor based on your medical history and a physical exam.
Have written proof of any previous PCV (pneumococcal vaccine) doses, showing the vaccine name and the date it was given. The most recent PCV dose must have been given a required number of days before the study vaccine is given, and children under 2 years must also meet this timing rule.
If you are in the oldest age group (5 to younger than 18 years), you must have a negative urine pregnancy test, and if you could become pregnant you must agree to use a highly reliable method of birth control (contraception) that has less than a 1 % chance of failure each year, during the study and for at least 28 days after the last dose.
Your parent or legal guardian must be able to sign a written permission form called informed consent. Depending on your age, you may also need to give your own agreement, known as assent, either spoken or written.

Who cannot join the trial?

14 criteria

You have had a severe allergic reaction (such as anaphylaxis) to any vaccine, any ingredient in the study vaccine, or to a diphtheria‑containing vaccine.
You have a medical or mental health condition, including thoughts of suicide in the past year or suicide attempts in the past five years, or any laboratory result that the doctor thinks makes participation unsafe.
You are currently taking medicines that suppress the immune system (such as chemotherapy drugs, strong corticosteroids, or have had radiation therapy), or you plan to start them before the final blood draw.
You have received blood products, immune‑modulating immunoglobulins or monoclonal antibodies that lower the immune system within the last 60 days, or you plan to receive them before the final blood draw.
You are using any experimental drug, vaccine, or medical device and will continue to use it during the study.
You are a child, grandchild, or other close family member of the study staff or sponsor employees who are directly involved in the trial.
You have a major brain or nerve disorder, such as a seizure (including fever‑related seizures), cerebral palsy, encephalopathy, hydrocephalus, or similar conditions.
You have a major birth defect or a serious long‑term illness.
You have ever had a confirmed invasive infection caused by the bacteria Streptococcus pneumoniae.
You have a known or suspected immunodeficiency (weak immune system), such as low antibody levels, DiGeorge syndrome, cancer, leukemia, lymphoma, or have had an organ or bone‑marrow transplant.
You have a bleeding disorder that could make an intramuscular injection unsafe.
You were born without a spleen, have a non‑functioning spleen, or have had your spleen removed surgically.
You have any other acute or chronic health problem or abnormal lab result that the doctor believes increases risk or could affect the study results.
If you are in the specific group “Cohort 3 IOCBP,” you cannot be pregnant or breastfeeding.

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Jagiellońskie Centrum Innowacji Sp. z o.o.
Cracow, Poland

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Investigated drugs

Prevenar 20
is a vaccine that contains pieces of 20 different types of the pneumonia‑causing bacteria, attached to a harmless protein. It is given as an injection into the muscle. The vaccine helps the body’s immune system learn to recognize these bacteria so that, if the person is later exposed, the immune system can fight the infection and prevent serious illness such as pneumonia, ear infections, or meningitis.
PF‑07872412
is an experimental pneumococcal conjugate vaccine being studied in this trial. Like the approved vaccine, it includes parts of 20 pneumococcal strains linked to a protein carrier and is administered by intramuscular injection. The purpose of testing this vaccine is to see if it is safe, well‑tolerated, and able to generate a strong immune response in healthy children and adolescents when used as a catch‑up vaccination.

What is already known about the treatment

Prevenar 20
It is supplied as a 0.5 ml suspension for injection and is given intramuscularly with a pre‑filled syringe. The vaccine is already approved and widely used to prevent pneumococcal disease. It protects against infection by 20 different serotypes of Streptococcus pneumoniae. The polysaccharide sugars are linked to the harmless protein CRM197 and adsorbed on aluminium phosphate, which helps the immune system produce protective antibodies; it is classified as a pneumococcal conjugate vaccine.
PF-07872412
This investigational product is also a 0.5 ml suspension for injection administered intramuscularly as a catch‑up vaccine for children and adolescents. It is still in clinical development and has not yet received regulatory approval. The vaccine contains the same 20 pneumococcal polysaccharides conjugated to CRM197 and adsorbed on aluminium phosphate, aiming to protect against those serotypes. By presenting bacterial sugars attached to a protein carrier, it stimulates the body to make antibodies and is classified as a multivalent pneumococcal conjugate vaccine under investigation.

Investigated diseases

Pneumococcal disease - This infection is caused by the bacterium Streptococcus pneumoniae, which often lives harmlessly in the nose and throat. It can spread to the lungs, causing pneumonia, or move to the ears and sinuses, leading to ear infections or sinusitis. When the bacteria enter the bloodstream, they can reach other parts of the body such as the brain, causing meningitis. The illness usually begins with mild symptoms like cough or fever and can become more extensive as the bacteria multiply. Without treatment, the infection can spread from the initial site to other organs, worsening the condition.