Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial
Amanda Jane Leach, Edward Kim Mulholland, Mathu Santosham, Paul John Torzillo, Ngiare Joy Brown, Peter McIntyre, Heidi Smith-Vaughan, Sue Skull, Anne Balloch, Ross Andrews, Jonathan Carapetis, Joseph McDonnell, Vicki Krause, Peter Stanley Morris
BMJ OPEN | BMJ PUBLISHING GROUP | Published : 2015
INTRODUCTION: Otitis media (OM) starts within weeks of birth in almost all Indigenous infants living in remote areas of the Northern Territory (NT). OM and associated hearing loss persist from infancy throughout childhood and often into adulthood. Educational and social opportunities are greatly compromised. Pneumococcus and non-typeable Haemophilus influenzae (NTHi) are major OM pathogens that densely colonise the nasopharynx and infect the middle ear from very early in life. Our hypothesis is that compared to current single vaccine schedules, a combination of vaccines starting at 1 month of age, may provide earlier, broadened protection. METHODS AND ANALYSES: This randomised outcome assess..View full abstract
Awarded by Australian National Health and Medical Research Council, NHMRC
The PREVIX_COMBO trial is funded by the Australian National Health and Medical Research Council, NHMRC (Project Grant 605 810). The trial sponsor is the Menzies School of Health Research, Northern Territory, Australia.