Pneumococcal Vaccination of Australian Indigenous Mothers to See If It Protects Their Babies From Ear Disease

PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can prevent ear disease in infants.

Official Title

PneuMum: A Randomised Controlled Trial of Pneumococcal Polysaccharide Vaccination for Aboriginal and Torres Strait Islander Mothers to Protect Their Babies From Ear Disease

Conditions

Middle Ear Effusion
Tympanic Membrane Perforation
Acute Otitis Media
Streptococcus Pneumoniae

Study Type

Interventional

Study Design

Prevention, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study

Further Details

Each mother and infant will be followed from pregnancy until the baby is seven months of age. Children will receive all of their routinely recommended vaccinations in accordance with the standard vaccination schedule. Mothers will receive the 23 valent pneumococcal polysaccharide vaccine (23vPPV) either: a) during the third trimester of pregnancy; b) soon after child birth; or c) seven months after child birth (control group). The adult diphtheria, tetanus and acellular pertussis vaccine (dTPa) will be used as the control vaccine for the birth dose.

Primary Outcome Measures: Prevalence of ear infection at seven months of age, defined as middle ear effusion or tympanic membrane perforation or acute otitis media; Nasopharyngeal carriage of vaccine type pneumococci at seven months of age