Status:
COMPLETED
Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines
Lead Sponsor:
Alba Maria Ropero
Collaborating Sponsors:
Centers for Disease Control and Prevention
Ministry of Public Health, Argentina
Conditions:
Vaccine Response Impaired
Eligibility:
All Genders
12-24 years
Phase:
PHASE4
Brief Summary
This study evaluates seroconversion against measles, mumps, rubella and yellow fever following vaccination. One-third of children will receive both yellow fever and measles, mumps, and rubella (MMR) v...
Detailed Description
The World Health Organization (WHO) and the Pan American Health Organization recommend that yellow fever and measles, mumps and rubella (MMR) vaccines be administered on the same day or at least 4 wee...
Eligibility Criteria
Inclusion
- Age 12 to 24 months at the time of enrollment
- Healthy child, determined by clinical history
- Availability to do study visits and blood sampling on days 28 + 7 and 56 + 14
- Informed consent signed by parents
Exclusion
- Previous vaccination against yellow fever, measles, mumps, or rubella
- History of yellow fever, measles, mumps or rubella
- Contraindication for any of the study vaccines: yellow fever vaccine or triple viral vaccine, including:
- Allergy to eggs, gelatin, or neomycin
- Weakened immunological function, including HIV infection, primary immunodeficiencies, having received immunosuppressive doses of oral or injectable corticosteroids (or equivalent), having received immunomodulators or chemotherapeutic agents
- Thymus disease
- Serious illness/fever (mild illness without fever is not an exclusion criterion)
- Administration of immunoglobulins or other blood derivative within 6 months of enrollment in the study or during the study
- a. Exception: children with a history of Kawasaki disease who received gammaglobulin cannot be enrolled if they received it in the previous 11 months.
- Administration of any other attenuated viral vaccine (i.e., for chickenpox) in the month prior to enrollment, or if the administration of any other attenuated viral vaccine is expected during the study (up to 3 months)
- Not being available for the entire study period (up to 3 months), or not able to make the scheduled visits or complete the study procedures
- Participating in another clinical drug trial of a drug, vaccine, or medical device
- Any condition that, in opinion of the study staff, represents a health risk to the participant or interferes with the evaluation of the response to the vaccine (i.e., children in percentile ≤ 3 in the height/weight tables will be considered undernourished and cannot be selected)
Key Trial Info
Start Date :
November 23 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
851 Patients enrolled
Trial Details
Trial ID
NCT03368495
Start Date
November 23 2015
End Date
June 30 2018
Last Update
May 21 2019
Active Locations (4)
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1
SAMIC Eldorado Hospital
Eldorado, Misiones Province, Argentina
2
SAMIC Obera Hospital
Oberá, Misiones Province, Argentina
3
Favoloro Hospital
Posadas, Misiones Province, Argentina
4
IPS Hospital
Posadas, Misiones Province, Argentina