Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03368495|
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vaccine Response Impaired||Biological: Co-administration of MMR/YF Biological: MMR followed by YF Biological: YF followed by MMR||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||851 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines in Children Under 2 Years Old in Argentina|
|Actual Study Start Date :||November 23, 2015|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 30, 2018|
Experimental: Co-administration of MMR/YF
Participants randomized to this arm will receive both MMR and yellow fever vaccines on Day 0.
Biological: Co-administration of MMR/YF
Both MMR & yellow fever vaccines administered on Day 0.
Active Comparator: MMR followed by YF
Participants randomized to this arm will receive MMR vaccine on Day 0 followed by yellow fever vaccine on Day 28.
Biological: MMR followed by YF
MMR vaccine administered on Day 0 and yellow fever vaccine administered on Day 28.
Active Comparator: YF followed by MMR
Participants randomized to this arm will receive YF vaccine on Day 0 followed by MMR vaccine on Day 28.
Biological: YF followed by MMR
Yellow fever vaccine administered on Day 0 and MMR vaccine administered on Day 28.
- Seroconversion after yellow fever vaccination using the plaque reduction neutralization test (PRNT). [ Time Frame: 28-35 days post-vaccination ]PRNTs will be used to measure antibody titers for yellow fever.
- Seroconversion after MMR vaccination using the ELISA method. [ Time Frame: 28-35 days post-vaccination. ]The ELISA method will be used to measure antibody titers for measles, mumps, and rubella.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368495
|SAMIC Eldorado Hospital|
|Eldorado, Misiones, Argentina|
|SAMIC Obera Hospital|
|Obera, Misiones, Argentina|
|Posadas, Misiones, Argentina|
|Posadas, Misiones, Argentina|
|Principal Investigator:||Cristian Biscayart, MD||Minsterio de Salud de la Nacion, Argentina|