Status:
UNKNOWN
PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers to See if it Protects Their Babies From Ear Disease
Lead Sponsor:
University of Melbourne
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Menzies School of Health Research
Conditions:
Middle Ear Effusion
Tympanic Membrane Perforation
Eligibility:
FEMALE
16-39 years
Phase:
PHASE3
Brief 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 diseas...
Detailed Description
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 diseas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00310349
Start Date
March 1 2006
End Date
January 1 2009
Last Update
December 13 2007
Active Locations (1)
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1
Menzies School of Health Research
Darwin, Northern Territory, Australia, 0811