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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 April 2024 |
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Main ID: |
NCT02961231 |
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Date of registration:
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01/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of PCV Schedules in a Naive Population in Vietnam
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Scientific title:
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Evaluation of PCV Schedules in a Naive Population in Vietnam |
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Date of first enrolment:
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October 1, 2016 |
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Target sample size:
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18652 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02961231 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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LAYMYINT YOSHIDA, MBBS, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Tropical Medicine, Nagasaki University, Nagasaki |
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Key inclusion & exclusion criteria
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Inclusion Criteria: All children living in the intervention communes in Nha Trang city,
whose parents or guardian give informed consent will be eligible to receive PCV in
accordance with their age.
Exclusion Criteria: Children who are not fit enough to receive national vaccination program
vaccine for health reason (eg.fever, currently under medication due to illness such as
pneumonia, diarrhea, etc) in accordance with Vietnam national immunization guidelines. This
will be decided by the medical doctor in charge of the vaccination at commune health center
in accordance with Vietnamese guideline.
Age minimum:
2 Months
Age maximum:
36 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pneumonia, Pneumococcal
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Intervention(s)
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Biological: PCV 0p+1
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Biological: PCV 2p+1
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Biological: PCV 1p+1
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Biological: PCV 3p+0
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Primary Outcome(s)
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vaccine type pneumococcal carriage
[Time Frame: up to 60 months after PCV intervention]
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Secondary ID(s)
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OPP1139859
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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