Flu (influenza) vaccine studies

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H1N5 (Avian Flu or Bird Flu) Study is recruiting healthy children aged between 3 years and 17 years.
H5N1 (avian influenza) could be a contender for the next influenza (‘flu) pandemic. Avian ‘flu virus (H5N1) is a virus found mainly in domestic and wild birds. Since 1997, avian H5N1 influenza virus has caused severe disease and death in hundreds of people, particularly in Southeast Asia and has since spread to Europe and Africa. 

This research study will look at the safety and how well the vaccine works in producing protective antibodies against the H5N1 virus in children aged 3 to 17 years. This vaccine has already been studied in over 5000 adults and shown to be safe. The vaccine is licensed in the European Union for use in a pandemic situation in adult subjects.
 
Participants will receive the study vaccine (H5N1 vaccine).

The study involves:

H1N1 Swine 'Flu Vaccine study for Children

Adult Flu Efficcacy 18 years to 64 years inclusive.

We are testing the effectiveness of an Australia 'flu vaccine when it is given to healthy adults aged 18 to 64 years. This is a continuation of the 2008 'Flu Busters Study. Each participant will receive either this years 'flu vaccine or a placebo. Throughout the study period (which is at least 6 months), we will ask participants to contact us if they develop any 'flu-like illnesses so that we can test for the 'flu and provide any treatment needed. The study involves:

• 2 visits to the study centre, 21 days apart. There may be more visits if you have any 'flu-like illnesses
• 1 injection (this years 'flu vaccine or a placebo) 
• Participants will be asked to keep a record of any symptoms that may occur following their injection at Visit 1
• NO blood test is needed

You can be involved if you:

• are aged 18 to 64 years
• have no chronic medical conditions
• are not a health care worker who is required to have an annual 'flu vaccine
• are not pregnant
• have not had a 'flu vaccine in the last 6 months
• did not participate in the 2008 'Flu Busters Study

STUDY STATUS:  Recruitment completed.

Influenza Vaccine Study in 6 month to 17 year olds

• Will attend 2 or 3 study visits.
• Will have a check up by one of our Doctor’s at the first visit, and the other visits only if necessary.
• Will be asked questions about their health and any medications they have been taking.
• Will receive 1 or 2 doses of the ‘flu vaccine Fluvax® (an injection into the arm). 
• will have their temperature recorded.
• For girls  9 years of age or older, a urine pregnancy test will be done before the Fluvax® is given, and at the second study visit.
• Will be asked to record information in a paper diary about how they feel for 7 days after the Fluvax injection. Also we ask you to record any other illnesses you might get over the next 30 days.
• Will be telephoned 6 months after the last dose of Fluvax® to see how you are.
• NO blood test is needed.

STUDY STATUS: Recruitment completed.

Children's Western Australia Influenza  Vaccine Effectiveness Study

VTG in conjunction with the Health Department of WA are involved in a very exciting study to look at the effectiveness of the influenza vaccine in children under 5 years of age. 

Health Professionals involved in the study will be asking parents of children who present at their practice or participating hospital with an ‘influenza-like-illness’ eg a fever, chills, cough, sore throat, nasal congestion, and will be asked if they wish for their child to take part in the study. This will involve taking a nasal swab that will test for the influenza virus and answering a short questionnaire.  All parents will receive a follow up phone call to inform them of their child’s nasal swab result.

If the study shows that the vaccine is effective in preventing the ’flu amongst children we hope that it will be  recommended to be included on the routine immunisation schedule in all states and territories

STUDY STATUS: Recruitment completed.

Influenza Vaccine Efficacy Study (2008 )

The purpose of these research studies is to identify a vaccine that may prevent the spread of avian influenza or bird flu’ in the event of a pandemic and to determine which of two different formulations produce the best immune response. A low dose of this vaccine has already been tested in other Australian adults and is shown to be safe. There is no live virus in the vaccine which means there is no chance of catching the infection from the vaccination. Our study is looking at the effectiveness of two different doses of the vaccine to determine the optimal amount of vaccine required to provide effective protection against bird flu. This research was conducted in Perth, Melbourne and Adelaide and has involved children, adults and the elderly. We enrolled 87 children age 6 mths to 8 years, 150 adults and 91 senior citizens, the oldest being 86 years of age.

STUDY STATUS: Completed

Children’s Influenza Vaccine Study (2005 to 2006)

In 2005, the VTG with colleagues in Melbourne studied the CSL influenza (flu) vaccine in children from aged 6 months to 9 years. We are pleased to report that the two doses of flu vaccine were well-tolerated (symptoms similar to other childhood vaccines) and produced excellent antibody responses even in the youngest children. The subjects completed their booster phase in June 2006 to see how long the protection lasts for. We hope this information will aid in the decision as to whether flu vaccine should be considered for all young children. This approach may also help reduce the spread of flu in the community as young children are usually the first age group to get infected and are most likely to spread the virus as they are contagious for longer.

STUDY STATUS: Completed.

Elderly Influenza Vaccine Study (2005)

The VTG was involved in an influenza vaccine study in the elderly at Fremantle Hospital in 2005. The aim of the study was to try and improve immune responses in the elderly and use less vaccine. A specially-prepared flu vaccine was given to some of the study participants under the skin while others were given the routine flu vaccine in the usual manner, injected into the muscle. Initial results of the study show that injecting the vaccine under the skin is safe and antibody results are promising.

STUDY STATUS: Completed.