Pneumococcal disease can be serious for young children. Up to 2 out of 3 children under the age of 5 carry the bacteria in their nose and throat, increasing their risk of infection.
According to the Centers for Disease Control and Prevention (CDC), vaccinating your child is the best way to help protect against pneumococcal disease. But today’s vaccines don’t defend against all bacterial strains. That’s why we are working to develop a vaccine that aims to expand protection against more bacterial strains than our current pneumococcal vaccines.
This study is enrolling healthy toddlers between 12 and 15 months of age who have previously received 3 doses of Pfizer’s currently approved and licensed pneumococcal vaccine (Prevnar 20®) at 2, 4, and 6 months of age.
To see if this study may be a good fit for you and your family, click “get started” and answer a few questions. There will be other study requirements that the study team will discuss with you, should you choose to take part.
Age
12 to 15 months
Vaccination status
Received 3 infant doses of Prevnar 20® at 2, 4, and 6 months of age
Each clinical trial has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if your child qualifies to enroll in the study.
Answer a 2-minute questionnaire.
A first step as you consider this study is to answer a 2-minute online questionnaire about your child’s health and medical history. If your answers show the study might be a good fit for your child, you may choose to have your contact information shared with a Pfizer Clinical Trial Contact Center Navigator.
Speak with a study representative.
If you’re interested, a Pfizer Clinical Trial Contact Center Navigator will call you and do a more detailed review of the study and your child’s medical history to see if they may be able to participate and be referred to a study clinic that you select.
Confirm your child’s eligibility.
Your answers to these questions will only be linked to you if your responses indicate that your child may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you or your child. Only the study staff can determine if your child meets the study’s eligibility criteria and is able to enroll in the study.
Children enrolled in this study will be randomly assigned to receive either the study vaccine (called PG4) or a licensed pneumococcal vaccine made by Pfizer (Prevnar 20®).
Your toddler will receive either 1 or 2 doses of PG4 or 1 dose of Prevnar 20®. No children will receive a placebo (vaccine with no active ingredients) in this study.
The study will last for about 6 to 8 months and will require 3 to 4 study visits. There is no cost to participate, and you will be paid for completing study-related activities (amount varies by location).
We know nothing is more important to you as a parent than your child’s wellbeing. 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 throughout the study by the study team.
Number of vaccine doses
Either 1 or 2 doses
Visit schedule
3-4 visits over 6-8 months
Study-related costs
No cost to participate, and you will be paid for your time and effort
Pneumococcal disease is a group of illnesses caused by a type of bacteria called Streptococcus pneumoniae. The bacteria can cause various infections, including:
Some groups are more at risk for severe illness from pneumococcal infections, including younger children, older adults, and people with certain medical conditions. Children under 2 are at a higher risk of infections from pneumococcal bacteria than most other age groups.
According to the Centers for Disease Control and Prevention (CDC), vaccinating your child is the best way to help protect against pneumococcal disease.
Age, genetics, and environmental factors can affect how different children respond to the same vaccine. It’s important to have vaccines that can prevent infection and illness in anyone. To develop better vaccines for everyone, we need families of all backgrounds to get involved in vaccine research.
Taking part in this study may help improve vaccine protection not only for your child, but also other children in the future. Thank you again for considering this clinical trial.
No children will receive a placebo (vaccine with no active ingredients) in this study. Your child will receive either the study vaccine (PG4) or an approved and licensed pneumococcal vaccine made by Pfizer (Prevnar 20®).
There is no cost to participate, and you will be paid for completing study-related activities.
Yes, participation in clinical trials is completely voluntary. Your child’s participation is your choice. You can leave this clinical trial at any time and for any reason.
