Pneumococcal disease is caused by a type of bacteria called Streptococcus pneumoniae. It is a major cause of ear infections, as well as serious infections of the blood, lungs (pneumonia) and brain (meningitis).
Although serious pneumococcal disease is rare, babies and children under five years of age are at the greatest risk.
In this study, researchers are investigating a new pneumococcal vaccine that may offer babies and young children greater protection from pneumococcal disease.
What will researchers investigate?
As per Australia’s National Immunisation Program, all babies are currently recommended to receive a pneumococcal vaccine at six - eight weeks, four months and 12 months of age to protect them from pneumococcal disease. The current vaccine, Prevenar 13, provides protection against 13 types of the pneumococcal bacteria.
In this study, researchers will be evaluating the immune response to a new vaccine that has been designed to protect babies against 15 different types of pneumococcal bacteria.
What happens in the study?
Participation in the study will be until your baby is 18 -21 months of age, and involvement will include:
Visits to our study clinic at Perth Children’s Hospital 5-6 times during the study for vaccinations and check-ups. Babies will receive the new pneumococcal vaccine or Prevenar 13 from approximately two months of age. They will receive two additional doses at four and six monthsof age and then a booster at 12 months. All routine baby immunisations will also be provided in the study clinic.
Follow-up phone calls, about 5 times during the study, to ask about your baby’s health.
Babies born prematurely will have three blood tests taken throughout the study to assess their immune response to the vaccine.
Participation in the study is voluntary. Your child will receive the pneumococcal vaccine (Prevenar 13) through the National Immunisation Program if you decide not to participate in the study.
Who can participate?
Healthy babies six to 12 weeks of age who have not yet received their routine baby immunisations (except for Hepatitis B vaccine at birth). Babies born prematurely are welcome to participate in the study. There are additional eligibility criteria that the study doctor can discuss with you.
Please contact the study staff at the Vaccine Trials Group if you would like more information or to get involved. Phone: 0400 450 240 Email: firstname.lastname@example.org
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