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 babies between 6 and 14 weeks old who have not received 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
6 to 14 weeks
Medical and vaccination history
Have not 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 your baby qualifies to enroll in the study.
What to expect
If this study is a good fit for your little one, here’s what you can expect:
- Babies enrolled in this study will be assigned by chance (like pulling a number out of a hat) to receive either 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®.
- Your baby will receive 4 vaccine doses over about 1 year. The doses will be given at 2, 4, 6, and 12-15 months of age in line with the schedule currently recommended for childhood pneumococcal vaccination.
- Participation lasts about a year and a half and includes 6 in-person visits and 1 phone call with the study team. 4 of these visits can take place during well-baby visits.
- 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 baby’s well-being. Before joining the study, you will be given all the details about participation, including potential benefits and risks. Your baby’s health will be carefully monitored by the study team for the duration of the trial.
Number of vaccine doses
4 doses following the recommended dosing schedule for pneumococcal vaccines
Study visit schedule
At least 6 in-person visits and 1 phone call over about a year and a half
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)
Babies are especially vulnerable to pneumococcal disease because their immune systems are still developing. Getting your baby 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 baby, but also other children in the future.
Watch a short video about vaccine clinical trials for children
Frequently asked questions
Your baby will receive 4 doses 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. 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 baby 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.
You will need to use an electronic diary (eDiary) to report any changes in your baby’s health every day for at least 7 days after each study 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.
