We are looking for healthy mothers and their babies to take part in a new study investigating immune responses to the seasonal influenza vaccine when used under six months of age.
Influenza is the most common vaccine preventable disease and young babies are at high risk of a severe infection. Influenza vaccinations are currently licensed for babies six months or older, leaving young babies unprotected when they are most vulnerable.
What is the FluBub Study?
The FluBub Study aims to learn more about the safety and effectiveness of giving the influenza vaccine to younger babies and providing them with much-needed protection earlier in life.
Researchers will evaluate the baby’s immune response to the seasonal flu vaccine when it is given at two months of age in comparison to six months as per the current National Immunisation Program. This information may help find a better way to protect newborn babies from influenza and guide policy changes to the recommended vaccination program.
What does the study involve?
Participation in the FluBub Study will last between 12 – 16 months and involve:
Five visits to the study clinic located at Perth Children’s Hospital, starting when your baby is two months old. Babies will receive their influenza vaccination and booster shot as part of these visits.
One blood test from the mother to assess their immune status, plus optional breast milk samples to look at the antibodies it contains.
Either three or four blood tests for babies to observe their baseline immune status and then their immune responses after having their first flu vaccination and booster. This will be performed by study staff who are very experienced in blood tests for babies.
All participants are invited to return next flu season to receive their seasonal flu vaccinations and have two follow-up blood tests.
Participation in the study is voluntary and reasonable travel costs will be reimbursed.
Is it safe?
All vaccines administered during the course of this study have been approved for children and babies aged over six months in Australia. While the vaccine is not currently licensed in children younger than six months, this is a second phase safety study and previous studies have shown the influenza vaccine to be safe when given to young babies.
Safety is our priority and we will be closely monitoring all babies involved in the study. Vaccination 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 doctor should you have any concerns.
Who can take part?
Healthy mothers aged 25 – 35 years are invited to participate.
Eligible babies must have been born from 37 weeks gestation onwards and aged eight weeks or less when first enrolled in the study. Participation must begin before babies have received their first influenza vaccination.
Please contact the FluBub Study staff if you would like more information or to get involved.