We are looking for children and teenagers to take part in an important study investigating the effectiveness of a new combination booster vaccine designed to protect against tetanus, diphtheria, pertussis (whooping cough) and polio.
There are only a limited number of vaccines licensed for use in Australia that can provide protection against this combination of diseases. Booster vaccines are recommended for children at four years of age on the National Immunisation Program, and are also given to teenagers and adults. Unfortunately, high demand and world-wide shortages mean they are often unavailable for those who need it most. Participating in the ComboVax Study will help pave the way for development of a new combination booster vaccine and ensure children always have access to vital protection.
What will researchers investigate?
Researchers will evaluate the body’s immune response to the study vaccine in comparison to one of the existing combination vaccines provided in Australia. This information will help researchers learn more about the safety and effectiveness of the study vaccine and could guide future policy changes to the National Immunisation Program.
What does the study involve?
Participation will last for up to 44 days and involve:
Three or four visits to the study clinic located at Perth Children’s Hospital. Participants will be randomly chosen to receive either the study vaccine or the current licensed vaccine during a study visit.
Follow-up phone call to check how your child is feeling three days after their vaccination.
Two blood tests to evaluate the body’s immune responses. Participants will have one test prior to vaccination and the second test at the final study visit.
Involvement is voluntary and reasonable parking costs will be reimbursed for appointments at Perth Children’s Hospital.
Is it safe?
Safety is our priority and we will be closely monitoring all participants involved in the ComboVax Study.
This is a second phase safety study, with previous studies involving similar combination vaccines reporting that they are generally well tolerated and have a good safety profile.
Vaccination(s) can sometimes cause mild discomfort, swelling or redness at the injection site. The study team will be paying close attention for any potential side effects and you will have direct contact with the study team should you have any concerns.
Who can take part?
Children and teenagers aged between 4 – 17 are invited to participate in the ComboVax Study.
Please contact the Vaccine Trials Group study staff if you would like more information or to get involved.