Meningitis Vaccine Studies

The Toddler Four in One  (ACW-135) Meningitis Vaccine Study for toddlers aged 10-12 months


The Toddler Four in One  

Help us find a vaccine to protect against four types of meningococcal disease.

  Meningococcus (Neisseria meningitidis) is a bacterium (a type of germ) that can cause several serious diseases, including meningitis (infection of the membranes covering the brain), meningococcemia (infection of the blood), infection of the joints, infection around the heart, and pneumonia.  Meningococcal disease can occur in people of all ages.  The symptoms of meningococcal disease are similar to other diseases, with fever, aches, chills, and headache.  The disease progresses rapidly, so even with proper treatment, the death rate is about 7% to 19% in patients with any type of meningococcal disease, and is as high as 53% in patients with meningococcemia.  About 20% of patients who survive meningococcal meningitis are left with serious neurological (brain or nerve) damage.There are at least 13 different types of meningococcus bacteria.  The five types   that are responsible for causing the most disease are called A, B, C, Y, and W-135 The Vaccine Trials Group, Telethon Institute for Chid Health Research are conducting a  vaccine study that may protect toddlers against four types of meninococcus bacteria that cause meningococcal disease.

What does the study involve:

  • 2 visits to the clinic
  • 2 blood tests (an anaesthetic cream can be used)
  • 1 vaccine ( study vaccine or   Men C vaccine)
  • completion of diary card
  • routine 12 month vaccines (measles, mumps, rubella and Hib vaccine at the 2nd visit)

 All study subjects will be notified at the end of the study about their child’s response to the vaccine and if required will be offered a booster vaccine if they have low protection against type C meningococcal disease.  

The Combined Meningitis Vaccine Study for toddlers aged 12-18 months


The purpose of this study is to try to reduce the number of injections that toddlers receive while still protecting them against the germs that causes meningitis. The current Australian Immunisation Schedule for babies aged 12 months is Meningoccocal C (MenC), Haemophillus Influenzae type b (Hib) and measles, mumps and rubella (MMR) given as three different injections. This study will look at whether the combined vaccine (HibMenC) is as effective as when given separately. The MMR vaccine will also be given. The study will also assess how long the protection lasts for. The combined HibMenC vaccine is already licensed and being used for babies in the United Kingdom. We are looking for 100 healthy toddlers aged between 12 and 18 months who have not yet had their 12-month vaccinations.

STUDY STATUS: Recruitment closed, study is ongoing.

The Meningococcal B Vaccine study for adults 18-25 years of age (2006 to 2007)

Sponsored by Wyeth, this study is a phase 1 trial (meaning the first time the vaccine has been used in humans) of a new vaccine that is hoped will provide protection against meningococcal B disease. A vaccine for this disease has been elusive for many years however it is vital because the B strain is the most common type of Meningococcal disease in Western Australia, accounting for about 80% of cases. The aim of this study is to determine how well-tolerated and effective the vaccine is in adult participants aged between 18 and 25 years, a high-risk age group for the disease. Participants received three doses of vaccine or placebo over 8 months. This part of the study has now been completed and participants have volunteered to return for a follow up study.

STUDY STATUS: Recruitment closed, study is ongoing.

The Meningococcal B Vaccine study for Adolescents and Toddlers (2007)

These 2 studies commenced in 2007 following the Meningococcal B vaccine study for adults. Recruitment has closed and we are currently completing study appointments and preliminary results should be available at the end of the year. Further studies for infants may commence in 2008.

STUDY STATUS: Recruitment closed, study is ongoing.

The Combined Meningitis (HibMenCY) Vaccine Study for infants aged 6-12 weeks (2005 to 2007)

This study was run at three sites within Australia with 1100 babies involved. The recruitment for Perth began in April 2005 and the target of 200 babies was reached in February 2006. The study combines the Meningococcal C vaccine and the Meningococcal Y strain vaccine with the Haemophilus influenza type B (Hib) vaccine that is normally given at two, four and six months of age. The aim of this study is to see how well the new combined Hib-MenCY vaccine works when given to babies during their primary vaccination course. It is hoped that in the future, the use of combined vaccines will protect babies against more diseases at an earlier age with less actual injections. The study completed in June 2007 and data is now in the process of being analysed. We hope to receive results from this study by the end of this year.

STUDY STATUS: Study completed, results pending.

Last updated 16 July 2008