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 which increases 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’re researching ways to expand the protection offered by our pneumococcal vaccines.
This study is enrolling healthy babies who:
If your child is 12 weeks old or younger, click “get started” to see if this study may be a good fit for you and your family.
If you are currently expecting and due soon, you can still take the online questionnaire and sign-up to find a study location near you. The study team will contact you to explain the process for joining the study once your baby is old enough to participate.
Age
6 weeks to 14 weeks old
Vaccination status
No prior pneumococcal vaccines
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 or Pfizer’s currently approved and licensed pneumococcal vaccine (Prevnar 20®).
The study will last for about 16 to 19 months and will require 7 to 8 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
4 doses over about one year
Visit schedule
7-8 study visits over 16-19 months
Study-related costs
No cost to participate, and you will be paid for your time in the study
Pneumococcal disease is a group of illnesses caused by a type of bacteria called Streptococcus pneumoniae. The bacteria can cause various infections, including:
The CDC recommends that all babies receive a series of pneumococcal vaccine doses starting around 2 months of age as part of their routine childhood vaccinations.
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 baby will receive either the study vaccine (called PG4) or Pfizer’s currently approved and licensed pneumococcal vaccine (Prevnar 20®).
There is no cost to participate, and you will be paid for completing study-related activities.
If you are at least 34 weeks pregnant, you may complete the questionnaire to find a study location near you. They will explain the process for joining the study once your baby is old enough to participate. Your baby must be born at 36 weeks of pregnancy or later to be eligible.
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
