Status:
COMPLETED
Pneumococcal Vaccines Early and in Combination
Lead Sponsor:
Menzies School of Health Research
Conditions:
Otitis Media
Eligibility:
All Genders
28-38 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether an early schedule of a combination of three doses of PHiD-CV and one dose of PCV13, is superior to three doses of either PCV13 or PHiD-CV.
Detailed Description
Aboriginal children in the Northern Territory (NT) have high rates of otitis media caused by non-capsular H. influenzae (NCHi) and pneumococci. Pneumococcal conjugate vaccine has effectively reduced d...
Eligibility Criteria
Inclusion
- Indigenous infants
- 4 to 6 weeks of age
- Living in remote communities that have provided signed Expressions of Interest in participating in PREV-IX\_COMBO trial
- Intend to remain in their community until their baby is 7 months of age
- Eligible for routine vaccinations.
Exclusion
- Prior adverse reaction to pneumococcal conjugate vaccines according to Australian Immunization Handbook.
- Gestational age \< 32 weeks
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2018
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT01174849
Start Date
August 1 2011
End Date
March 15 2018
Last Update
October 18 2018
Active Locations (1)
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1
Menzies School of Health Research
Darwin, Northern Territory, Australia, 0811