Please use this identifier to cite or link to this item: http://docs.prosentient.com.au/prosentientjspui/handle/1/10438
Title: Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial.
Authors: Leach, Amanda Jane
Mulholland, Edward Kim
Santosham, Mathu
Torzillo, Paul John
Brown, Ngiare Joy
McIntyre, Peter
Smith-Vaughan, Heidi
Skull, Sue
Balloch, Anne
Andrews, Ross
Carapetis, Jonathan
McDonnell, Joseph
Krause, Vicki
Morris, Peter Stanley
Affiliation: Child Health Division, Menzies School of Heath Research, Darwin, Northern Territory, Australia..
Centre for International Child Health, Murdoch Childrens Research Institute, University of Melbourne, Melbourne, Victoria, Australia London School of Hygiene and Tropical Medicine, London, UK..
Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA..
Prince Alfred Hospital, Sydney, New South Wales, Australia University of Sydney, Sydney, New South Wales, Australia..
National Aboriginal Community Controlled Health Organisation, Canberra, Australian Capital Territory, Australia..
National Centre for Immunization Research and Surveillance, Sydney, New South Wales, Australia..
Child Health Division, Menzies School of Heath Research, Darwin, Northern Territory, Australia..
University of Western Australia, Perth, Western Australia, Australia..
Murdoch Childrens Research Institute, University of Melbourne, Melbourne, Victoria, Australia..
Child Health Division, Menzies School of Heath Research, Darwin, Northern Territory, Australia..
Telethon Kids Institute, Perth, Western Australia, Australia..
Strijen, The Netherlands..
Northern Territory Department of Health & Families, Darwin, Northern Territory, Australia..
Child Health Division, Menzies School of Heath Research, Darwin, Northern Territory, Australia Department of Paediatrics, Royal Darwin Hospital, Darwin, Northern Territory, Australia..
Issue Date: 16-Jan-2015
Citation: BMJ open 2015-01-16; 5(1): e007247
Abstract: 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. This randomised outcome assessor, blinded controlled trial will recruit 425 infants between 28 and 38 days of age and randomly allocate them (1:1:1) to one of three pneumococcal conjugate vaccine (PCV) schedules: Synflorix at 2, 4, 6 months of age, Prevenar13 at 2, 4 and 6 months of age, or an investigational schedule of Synflorix at 1, 2 and 4 months plus Prevenar13 at 6 months of age. The blinded primary outcomes at 7 months of age are immunogenicity of specific vaccine antigens (geometric mean concentration (GMC) and proportion of participants with above threshold GMC of 0.35 µg/L). Secondary outcomes at all timepoints are additional immunogenicity measures and proportion of participants with nasopharyngeal carriage of vaccine-type pneumococci and NTHi, and any OM, including any tympanic membrane perforation. Parental interviews will provide data on common risk factors for OM. Ethical approval has been obtained from NT Department of Health and Menzies HREC (EC00153), Central Australian HREC (EC00155) and West Australian Aboriginal Health Ethics Committee (WAAHEC- 377-12/2011). Final trial results, data analyses, interpretation and conclusions will be presented in appropriate written and oral formats to parents and guardians, participating communities, local, national and international conferences, and published in peer-reviewed open access journals. ACTRN12610000544077 and NCT01174849.
URI: http://docs.prosentient.com.au/prosentientjspui/handle/1/10438
DOI: 10.1136/bmjopen-2014-007247
Type: Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Subjects: IMMUNOLOGY
MICROBIOLOGY
PUBLIC HEALTH
Australia
Clinical Protocols
Female
Haemophilus Infections
Haemophilus influenzae
Humans
Infant
Infant, Newborn
Male
Nasopharynx
Pneumococcal Infections
Pneumococcal Vaccines
Research Design
Risk
Streptococcus pneumoniae
Vaccines, Conjugate
Immunization Schedule
Oceanic Ancestry Group
Appears in Collections:NT Health digital library

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