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) vaccines on the same day; one- third of children will receive MMR vaccine at enrollment followed by yellow fever vaccine 4 weeks later; one-third of children will receive yellow fever vaccine at enrollment followed by MMR vaccine 4 weeks later.
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 weeks apart to prevent interference between live vaccines. In 2011 a Brazilian study demonstrated lower seroconversion against yellow fever, rubella, and mumps when the two vaccines were administered on the same day compared with administering them separately. WHO urged that additional studies be conducted to examine this issue. This Phase IV study aims to determine if seroconversion against measles, mumps, rubella, and yellow fever after administration of MMR and yellow fever vaccines on the same day is non-inferior to seroconversion after sequential administration 28 days apart in health 12-month old children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
851
Both MMR \& yellow fever vaccines administered on Day 0.
MMR vaccine administered on Day 0 and yellow fever vaccine administered on Day 28.
Yellow fever vaccine administered on Day 0 and MMR vaccine administered on Day 28.
SAMIC Eldorado Hospital
Eldorado, Misiones Province, Argentina
SAMIC Obera Hospital
Oberá, Misiones Province, Argentina
Favoloro Hospital
Posadas, Misiones Province, Argentina
IPS Hospital
Posadas, Misiones Province, Argentina
Seroconversion after yellow fever vaccination using the plaque reduction neutralization test (PRNT).
PRNTs will be used to measure antibody titers for yellow fever.
Time frame: 28-35 days post-vaccination
Seroconversion after MMR vaccination using the ELISA method.
The ELISA method will be used to measure antibody titers for measles, mumps, and rubella.
Time frame: 28-35 days post-vaccination.
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