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

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

SUBMITTER: Leach AJ 

PROVIDER: S-EPMC4298104 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature