Status:
COMPLETED
PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers
Lead Sponsor:
Menzies School of Health Research
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Conditions:
Middle Ear Effusion
Tympanic Membrane Perforation
Eligibility:
FEMALE
17-39 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, the Tiwi Islands, or other remote community where consent has been obtained
- Intends to deliver child at the Royal Darwin Hospital or other designated hospital where consent has been obtained
- 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 :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT00714064
Start Date
June 1 2006
End Date
July 1 2011
Last Update
July 10 2014
Active Locations (1)
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1
Menzies School of Health Research
Darwin, Northern Territory, Australia, 0811