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PneuMum: a randomised controlled trial of pneumococcal polysaccharide immunisation for Aboriginal and Torres Strait Islander mothers to protect their babies from ear disease
This is a randomised controlled trial aimed to determine if maternal immunisation with 23 valent pneumococcal polysaccharide vaccine (23vPPV) can reduce pneumococcal carriage and middle ear disease among Aboriginal infants at seven months of age. The trial aims to recruit 210 Aboriginal women aged 18-39 years who have uncomplicated pregnancies: 70 will receive 23vPPV during the third trimester of pregnancy, 70 immediately postpartum, and 70 will act as a control group, receiving 23vPPV seven months after child birth. Each subject and their infant offspring will be followed-up after vaccination and at birth, one, two and seven months of age.
This study has the potential to show clinically significant benefits in the early life of high-risk infants. The additional ear, health and immunisation status assessments offered by this research program are also likely to benefit all participants. This is an affordable vaccine for families and if effective is likely to be a good option for mothers and infants at high risk and could lead to changes to policy related to the use of the vaccine.
Menzies School of Health Research abstract
Menzies School of Health Research
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Johnston V, Thomas DP, McDonnell J, Andrews RM (2011)
Maternal smoking and smoking in the household during pregnancy and postpartum: findings from an Indigenous cohort in the Northern Territory.
Medical Journal of Australia; 194(10): 556-559
Menzies School of Health Research (2009)
PneuMum: a randomised controlled trial of pneumococcal polysaccharide immunisation for Aboriginal and Torres Strait Islander mothers to protect their babies from ear disease.
Retrieved 16 April 2012 from http://www.menzies.edu.au/page/Research/Projects/Vaccination/PneuMum_a_randomised_controlled_trial_of_pneumococcal_polysaccharide_immunisation_for_Aboriginal_and_Torres_Strait_Islander_mothers_to_protect_their_babies_from_ear_disease/
Binks MJ, Moberley SA, Balloch A, Leach AJ, Nelson S, Hare KM, Wilson C, Morris PS, Nelson J, Chatfield MD, Tang ML, Torzillo P, Carapetis JR, Mulholland EK, Andrews RM (2015)
PneuMum: impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia.
Vaccine; In press(http://dx.doi.org/10.1016/j.vaccine.2015.10.101):