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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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4 September 2023 |
Main ID: |
NCT03098628 |
Date of registration:
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01/03/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Trial of Simplified Pneumococcal Vaccination in Vietnam II
VPTII |
Scientific title:
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Trial of Simplified Pneumococcal Vaccination in Vietnam II: The Herd Immunity Approach |
Date of first enrolment:
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March 8, 2017 |
Target sample size:
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2501 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03098628 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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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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Nguyen Vu Thuong, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Pasteur Institute |
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Name:
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Kim Mulholland, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Murdoch Childrens Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged between 2 months and 2 months plus 2 weeks;
- No significant maternal or perinatal history;
- Born at or after 36 weeks gestation;
- Written and signed informed consent from parent/legal guardian;
- Lives within approximately 30 minutes of the commune health centre;
- Family anticipates living in the study area for the next 22 months
Exclusion Criteria:
- Known allergy to any component of the vaccine;
- Allergic reaction or anaphylactic reaction to any previous vaccine;
- Known immunodeficiency disorder;
- Known HIV-infected mother;
- Known thrombocytopenia or coagulation disorder;
- Administration or planned administration of any immunoglobulin or blood product since
birth;
- Severe birth defect requiring ongoing medical care;
- Chronic or progressive disease;
- Seizure disorder;
- History of severe illness;
- Receipt of any 2 month vaccines through the Expanded Programme of Immunization (EPI)
program;
- Family plans on giving the infant Quinvaxem (DTP-Hib-HBV).
Additionally, enrolment will be deferred and infants asked to return to the health centre
one week later for reassessment if they have at least one of the following deferral
criteria:
- Axillary temperature =37.5°C or =35.5°C;
- Acute infection, especially bacterial;
- Oral administration of corticoid therapy in past 14 days; or
- Any of the following symptoms that interfere with normal activities: crying more than
usual, sleeping more than usual, or loss of appetite.
Age minimum:
2 Months
Age maximum:
10 Weeks
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pneumococcal Vaccine
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Intervention(s)
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Biological: PCV Vaccine
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Primary Outcome(s)
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Carriage of Vaccine Type pneumococci
[Time Frame: 12 months post vaccination, i.e. 24 months of age]
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Carriage of Vaccine Type pneumococci
[Time Frame: 12 months post last vaccination, i.e. 24 months of age]
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Secondary Outcome(s)
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Immunology sub-study
[Time Frame: 12 months post vaccination, i.e. 24 months of age]
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Immunology sub-study
[Time Frame: 12 months post last vaccination, i.e. 24 months of age]
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Secondary ID(s)
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HREC36027
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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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