Help us discover a way to expand protection for the next generation.
What is pneumococcal disease?
Pneumococcal [noo-muh-KOK-ul] disease is caused by pneumococcal germs. There are over 90 different types of pneumococcal germs. They can cause infections of the lungs (pneumonia), brain (meningitis), blood (bacteraemia) and ears (otitis media). Pneumococcal disease is often mild, but can be serious. Children younger than 2 years old are most likely to have a serious case of pneumococcal disease.
Doctors recommend approved pneumococcal vaccines as a way to protect children against pneumococcal disease. These vaccines provide protection against 10–13 types of pneumococcal germs. But could we expand this protection? With the help of a vaccine research study, we are evaluating an investigational vaccine to find out if it can provide protection against 20 types of pneumococcal germs.
What is the NeXXstep 12 study?
This study involving about 1200 children will evaluate the coverage and protection of an investigational pneumococcal vaccine compared to an approved pneumococcal vaccine.
We also want to find out about the safety of the investigational vaccine when it is given with other routine childhood vaccinations.
What does the NeXXstep 12 study involve?
Your child would be in the NeXXstep 12 study for about 11 months. He/she will receive other specific routine vaccinations during this time.
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Clinic Visit 1 at 2–3 months old* |
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Clinic Visit 2 at 4-5 months old* |
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Clinic Visit 3 4–6 weeks after Visit 2 |
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Clinic Visit 4 at 11-12 months old* |
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Clinic Visit 5 4–6 weeks after Visit 4 |
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*Approximate age of child **Blood sample may or may not be collected at this visit
We will collect a small blood sample (5 mL) from your child during some clinic visits. This helps us test your child’s immune response to the study vaccine (how much protection the study vaccine is providing). We may apply a numbing cream to your child’s skin before the collection to reduce any pain.
We will give you an electronic diary (e-diary) (a device or app on your phone), a digital thermometer and a calliper (a device to measure redness and swelling at the vaccination site). You must use the e-diary to record any reactions to each of the 3 study vaccinations your child will receive. Full training on how to use the e-diary, thermometer and calliper will be provided.
Does the NeXXstep 12 study have any risks?
All vaccine research has some risk, which may include things that could make your child feel unwell or uncomfortable. The most common side effects with the approved pneumococcal vaccine are pain, tenderness, redness or swelling at the injection site, fever, irritability (fussiness), decreased appetite and sleepiness. The side effects may be different with the investigational vaccine.
You will have the chance to review with the study team the most likely risks or discomforts expected from this study before agreeing to have your child participate.
Would there be any benefits for my child?
Children in the NeXXstep 12 study may produce antibodies that could help fight off a similar or greater amount of pneumococcal infections than approved pneumococcal vaccines, but there is no guarantee.
The health and well-being of every child who takes part will be monitored.
Is the NeXXstep 12 study an option for my child?
The NeXXstep 12 study may be an option for healthy babies who:
• are not premature
• are 6 to 16 weeks of age
• have not yet received the routine 2–3 month vaccinations.
There are other requirements for participation in the NeXXstep 12 study. The study doctor can explain these to you.
Please contact the Vaccine Trials Group study staff if you would like more information or to get involved.
Phone: 0400 450 240
Email: pneumo20@telethonkids.org.au