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

Study Start

March 2006; Expected completion: January 2009

Eligibility & Criteria

• Ages Eligible for Study: 16 Years – 39 Years
• Genders Eligible for Study: Female

Inclusion Criteria

• singleton uncomplicated pregnancy
• reside in Darwin, Maningrida, Wadeye or the Tiwi Islands
• intends to deliver child at the Royal Darwin Hospital
• has given informed consent to participate

Exclusion Criteria

• had 23vPPV within the previous three years
• had a previous dose of dTpa
• intends to leave the study area during the follow-up period
• HIV positive
• history of severe allergy, uncontrolled asthma or splenectomy

Total Enrolment

210

Contact Details

• Ross M Andrews, PhD 613 9345 4647 ross.andrews@mcri.edu.au
• Amanda J Leach, PhD 618 8922 8698 amanda.leach@menzies.edu.au
• Menzies School of Health Research, Darwin, Northern Territory, 0811, Australia