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

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.

Progress with rotavirus vaccines: summary of the Tenth International Rotavirus Symposium.

Over 350 scientific, public and private sector experts from 47 countries convened at the Tenth International Rotavirus Symposium in Bangkok, Thailand on 19-21 September 2012 to discuss progress in the prevention and control of rotavirus, the leading cause of diarrhea hospitalizations and deaths among young children worldwide. Participants discussed data on the burden and epidemiology of rotavirus disease, results of trials of rotavirus vaccines, postmarketing data on vaccine impact and safety from countries that have implemented rotavirus vaccination programs, new insights in rotavirus pathogenesis, immunity and strain diversity, and key issues related to vaccine policy and introduction.

Impact of immunizations on the disease burden of American Indian and Alaska native children.

American Indian and Alaska Native (AI/AN) people have suffered disproportionately from infectious diseases compared with the general US population. As recently as 25 years ago, rates of hepatitis A and B virus, Haemophilus influenzae type b, and Streptococcus pneumoniae infections were as much as 10 times higher among AI/AN children compared with the general US child population. In the past quarter century, routine use of childhood immunizations for hepatitis A and B viruses has eliminated disease disparities for these pathogens in AI/AN children, and significant decreases have been demonstrated for H influenzae type b, S pneumoniae, and pertussis. Nevertheless, certain infectious diseases continue to occur at higher rates in AI/AN children. The reason for continued disparities is most likely related to adverse living conditions such as household crowding, lack of indoor plumbing, poverty, and poor indoor air quality. Although tremendous strides have been made in eliminating disparities in infectious disease among AI/AN children, further gains will require addressing disparities in adverse living conditions.