Pfizer’s pneumococcal vaccines have helped to protect children for over 20 years. We’re committed to building on that legacy through ongoing research.
The vaccines available today defend against many types (strains) of pneumococcal bacteria, but they don’t protect against all. This means that while current vaccines are safe and effective, there is still a risk for children to be exposed to strains not covered by existing immunizations.
That’s why we are researching if an investigational formulation of our pneumococcal vaccine can help protect against more strains.
Who may participate
Joining a clinical trial is an important decision. Thank you for considering participation as an option that may be right for your family.
This study is enrolling healthy children and teens who:
- Are 15 to 23 monthsold and have received at least 2 prior doses of a pneumococcal vaccine, OR
- Are 2 to 17 yearsold and have received 0 to 4 prior doses of a pneumococcal vaccine
There are other requirements for taking part in this clinical trial. The study team will explain these to you if you’d like to learn more.
Age
15 months to 17 years
Medical and vaccination history
May or may not have previously received a pneumococcal vaccine
Each clinical trial has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this study is a good fit for your child, here’s what you can expect:
- Children enrolled in this study will be assigned by chance (like pulling a number out of a hat) to receive 1 dose of the study vaccine or an approved pneumococcal vaccine called Prevnar 20®. Out of every 3 participants, 2 will receive the study vaccine, and 1 will receive Prevnar 20®.
- Participation lasts about 6 months and includes 2 in-person visits and 1 phone call with the study team.
- There is no cost to participate, and health insurance is not required. You will also be paid for completing some study-related activities.
We know nothing is more important to you than your child’s well-being. Before joining the study, you will be given all the details about participation, including potential benefits and risks. Your child’s health will be carefully monitored by the study team for the duration of the trial.
Number of vaccine doses
1 dose
Study visit schedule
At least 2 in-person visits and 1 phone call over about 6 months
Study-related costs
No cost to participate, and you will be paid for completing study related activities
About pneumococcal disease
Pneumococcal disease is caused by Streptococcus pneumoniae bacteria. It can cause various infections, including:
- Otitis media (a middle ear infection)
- Pneumonia (a lung infection)
- Bacteremia (a blood infection)
- Meningitis (an infection of the lining of the brain and spinal cord)
- Sinusitis (a sinus infection)
Getting your child vaccinated is the best way to help prevent pneumococcal disease.
Watch a short video about pneumococcal disease
Joining this clinical trial could make a difference for children everywhere
We invite families of every background to join us in developing vaccines with expanded protection against pneumococcal disease.
Taking part in this clinical trial may help improve vaccine protection not only for your child, but also other children in the future.
Watch a short video about vaccine clinical trials for children
Frequently asked questions
Your child will receive 1 dose of either Prevnar 20® or the investigational vaccine which may reduce their risk of severe illness from pneumococcal disease. Additionally, their health will be closely monitored by the study team, and they will be contributing to research that could help protect millions of others around the world.
As with any vaccine, local reactions at the injection site can be common – such as tenderness, redness, or swelling. There is also potential for other symptoms like a fever or more serious side effects, including an allergic reaction. Study-related blood draws may cause discomfort, bruising, bleeding, and in rare cases, infection. There may be other risks that are unknown at this time. The study team will provide more information about the potential benefits and risks of taking part.
No children will receive a placebo (injection with no active ingredients) in this study. Your child will receive either the study vaccine or Prevnar 20® (an approved pneumococcal vaccine).
While all clinical trials come with some risks, participant safety is always the top priority. Clinical trials are reviewed by committees responsible for protecting the rights and safety of all participants. These committees continue to regularly review the trial’s progress to ensure there are no unnecessary or excessive risks to participants.
At the beginning of the clinical trial, the study doctor will ask about your child’s medical history, including previous vaccinations and any medications they are currently taking. Your child will also have their blood drawn 2 times during the [6 months] they are in the clinical trial. The study team will provide more information about required tests and procedures during the first study visit.
You will need to use an electronic diary (eDiary) to report any changes in your child’s health every day for at least 7 days after their vaccination. The study team will provide more information about the eDiary during the first study visit.
Participation is your choice. Your child can leave the clinical trial at any time, for any reason.
