NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
Pfizer’s pneumococcal vaccines have helped to protect children for over 20 years.
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 the protection against more bacterial strains than offered by our current pneumococcal vaccines.
This study is enrolling healthy babies who:
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.
Condition
Pneumococcal disease
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.
Children enrolled in this study will be randomly assigned to receive either the study vaccine or a licensed pneumococcal vaccine.
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
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 a licensed pneumococcal vaccine.
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
