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PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers to See if it Protects Their Babies From Ear Disease

NCT00310349 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2007-12-13

No results posted yet for this study

Summary

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. 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.

The study aims to recruit 210 Indigenous women aged 18-39 years who have an uncomplicated pregnancy. Following recruitment, subjects will be randomly assigned to one of the three groups.

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.

The primary outcome will be prevalence of ear infection at seven months of age, defined as middle ear effusion or tympanic membrane perforation or acute otitis media. Pneumatic otoscopy, video-otoscopy and tympanometry will be used in the ear examinations. The primary analyses will be a direct comparison of the proportion of infants in the control group who have nasopharyngeal carriage of vaccine type pneumococci at seven months of age compared to infants in each of the other two groups and a similar comparison of the proportion with middle ear disease.

Conditions

  • Middle Ear Effusion
  • Tympanic Membrane Perforation
  • Acute Otitis Media
  • Pneumococcal Infections

Interventions

BIOLOGICAL

23 valent pneumococcal polysaccharide vaccine

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Menzies School of Health Research

    collaborator OTHER

  • University of Melbourne

    lead OTHER

Principal Investigators

  • Ross M Andrews, PhD · The University of Melbourne and Murdoch Childrens Research Institute

  • Jonathan R Carapetis, PhD · The University of Melbourne and Murdoch Childrens Research Institute

  • Amanda J Leach, PhD · Menzies School of Health Research

  • Peter S Morris, PhD · Menzies School of Health Research

  • Edward K Mulholland, DM · The Univeristy of Melbourne and Murdoch Childrens Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Completion
2009-01-31

Countries

  • Australia

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00310349 on ClinicalTrials.gov