Randomized Controlled Trial

. 2015 Jan 16;5(1):e007247.

doi: 10.1136/bmjopen-2014-007247.

Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial

Affiliations

¹ Child Health Division, Menzies School of Heath Research, Darwin, Northern Territory, Australia.
² Centre for International Child Health, Murdoch Childrens Research Institute, University of Melbourne, Melbourne, Victoria, Australia London School of Hygiene and Tropical Medicine, London, UK.
³ Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
⁴ Prince Alfred Hospital, Sydney, New South Wales, Australia University of Sydney, Sydney, New South Wales, Australia.
⁵ National Aboriginal Community Controlled Health Organisation, Canberra, Australian Capital Territory, Australia.
⁶ National Centre for Immunization Research and Surveillance, Sydney, New South Wales, Australia.
⁷ University of Western Australia, Perth, Western Australia, Australia.
⁸ Murdoch Childrens Research Institute, University of Melbourne, Melbourne, Victoria, Australia.
⁹ Telethon Kids Institute, Perth, Western Australia, Australia.
¹⁰ Strijen, The Netherlands.
¹¹ Northern Territory Department of Health & Families, Darwin, Northern Territory, Australia.
¹² Child Health Division, Menzies School of Heath Research, Darwin, Northern Territory, Australia Department of Paediatrics, Royal Darwin Hospital, Darwin, Northern Territory, Australia.

PMID: 25596202
PMCID: PMC4298104
DOI: 10.1136/bmjopen-2014-007247

Randomized Controlled Trial

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 et al. BMJ Open. 2015.

. 2015 Jan 16;5(1):e007247.

doi: 10.1136/bmjopen-2014-007247.

Authors

Affiliations

¹ Child Health Division, Menzies School of Heath Research, Darwin, Northern Territory, Australia.
² Centre for International Child Health, Murdoch Childrens Research Institute, University of Melbourne, Melbourne, Victoria, Australia London School of Hygiene and Tropical Medicine, London, UK.
³ Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
⁴ Prince Alfred Hospital, Sydney, New South Wales, Australia University of Sydney, Sydney, New South Wales, Australia.
⁵ National Aboriginal Community Controlled Health Organisation, Canberra, Australian Capital Territory, Australia.
⁶ National Centre for Immunization Research and Surveillance, Sydney, New South Wales, Australia.
⁷ University of Western Australia, Perth, Western Australia, Australia.
⁸ Murdoch Childrens Research Institute, University of Melbourne, Melbourne, Victoria, Australia.
⁹ Telethon Kids Institute, Perth, Western Australia, Australia.
¹⁰ Strijen, The Netherlands.
¹¹ Northern Territory Department of Health & Families, Darwin, Northern Territory, Australia.
¹² Child Health Division, Menzies School of Heath Research, Darwin, Northern Territory, Australia Department of Paediatrics, Royal Darwin Hospital, Darwin, Northern Territory, Australia.

PMID: 25596202
PMCID: PMC4298104
DOI: 10.1136/bmjopen-2014-007247

Abstract

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 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.

Ethics and dissemination: 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.

Trial registration numbers: ACTRN12610000544077 and NCT01174849.

Keywords: IMMUNOLOGY; MICROBIOLOGY; PUBLIC HEALTH.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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Figures

**Figure 1**
PREV-IX_COMBO study sites in the Northern Territory and Western Australia.

See this image and copyright information in PMC

References

1. Leach AJ, Boswell JB, Asche V et al. . Bacterial colonization of the nasopharynx predicts very early onset and persistence of otitis media in Australian Aboriginal infants. Pediatr Infect Dis J 1994;13:983–9. 10.1097/00006454-199411000-00009 - DOI - PubMed
1. Mackenzie GA, Carapetis JR, Leach AJ et al. . Pneumococcal vaccination and otitis media in Australian Aboriginal infants: comparison of two birth cohorts before and after introduction of vaccination. BMC Pediatr 2009;9:14 10.1186/1471-2431-9-14 - DOI - PMC - PubMed
1. Morris PS, Leach AJ, Silberberg P et al. . Otitis media in young Aboriginal children from remote communities in Northern and Central Australia: a cross-sectional survey. BMC Pediatr 2005;5:27–37. - PMC - PubMed
1. Leach AJ, Morris PS, Mathews JD. Compared to placebo, long-term antibiotics resolve otitis media with effusion (OME) and prevent acute otitis media with perforation (AOMwiP) in a high-risk population: a randomized controlled trial. BMC Pediatr 2008;8:23 10.1186/1471-2431-8-23 - DOI - PMC - PubMed
1. Leach A, Wood Y, Gadil E et al. . Topical ciprofloxin versus topical framycetin-gramicidin-dexamethasone in Australian aboriginal children with recently treated chronic suppurative otitis media: a randomized controlled trial. Pediatr Infect Dis J 2008;27:692–8. 10.1097/INF.0b013e31816fca9d - DOI - PubMed

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Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial

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Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial

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