Back to resultsImmunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines
Primary Purpose
Vaccine Response Impaired
Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Co-administration of MMR/YF
MMR followed by YF
YF followed by MMR
Sponsored by
About this trial
This is an interventional prevention trial for Vaccine Response Impaired focused on measuring yellow fever vaccine, MMR vaccine, immunogenicity
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- SAMIC Eldorado Hospital
- SAMIC Obera Hospital
- Favoloro Hospital
- IPS Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Co-administration of MMR/YF
MMR followed by YF
YF followed by MMR
Arm Description
Participants randomized to this arm will receive both MMR and yellow fever vaccines on Day 0.
Participants randomized to this arm will receive MMR vaccine on Day 0 followed by yellow fever vaccine on Day 28.
Participants randomized to this arm will receive YF vaccine on Day 0 followed by MMR vaccine on Day 28.
Outcomes
Primary Outcome Measures
Seroconversion after yellow fever vaccination using the plaque reduction neutralization test (PRNT).
PRNTs will be used to measure antibody titers for yellow fever.
Seroconversion after MMR vaccination using the ELISA method.
The ELISA method will be used to measure antibody titers for measles, mumps, and rubella.
Secondary Outcome Measures
Full Information
NCT ID
NCT03368495
First Posted
November 21, 2017
Last Updated
May 17, 2019
Sponsor
Alba Maria Ropero
Collaborators
Centers for Disease Control and Prevention, Ministry of Public Health, Argentina
1. Study Identification
Unique Protocol Identification Number
NCT03368495
Brief Title
Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines
Official Title
Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines in Children Under 2 Years Old in Argentina
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 23, 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alba Maria Ropero
Collaborators
Centers for Disease Control and Prevention, Ministry of Public Health, Argentina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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) 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccine Response Impaired
Keywords
yellow fever vaccine, MMR vaccine, immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
851 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Co-administration of MMR/YF
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive both MMR and yellow fever vaccines on Day 0.
Arm Title
MMR followed by YF
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will receive MMR vaccine on Day 0 followed by yellow fever vaccine on Day 28.
Arm Title
YF followed by MMR
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will receive YF vaccine on Day 0 followed by MMR vaccine on Day 28.
Intervention Type
Biological
Intervention Name(s)
Co-administration of MMR/YF
Intervention Description
Both MMR & yellow fever vaccines administered on Day 0.
Intervention Type
Biological
Intervention Name(s)
MMR followed by YF
Intervention Description
MMR vaccine administered on Day 0 and yellow fever vaccine administered on Day 28.
Intervention Type
Biological
Intervention Name(s)
YF followed by MMR
Intervention Description
Yellow fever vaccine administered on Day 0 and MMR vaccine administered on Day 28.
Primary Outcome Measure Information:
Title
Seroconversion after yellow fever vaccination using the plaque reduction neutralization test (PRNT).
Description
PRNTs will be used to measure antibody titers for yellow fever.
Time Frame
28-35 days post-vaccination
Title
Seroconversion after MMR vaccination using the ELISA method.
Description
The ELISA method will be used to measure antibody titers for measles, mumps, and rubella.
Time Frame
28-35 days post-vaccination.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristian Biscayart, MD
Organizational Affiliation
Minsterio de Salud de la Nacion, Argentina
Official's Role
Principal Investigator
Facility Information:
Facility Name
SAMIC Eldorado Hospital
City
Eldorado
State/Province
Misiones
Country
Argentina
Facility Name
SAMIC Obera Hospital
City
Obera
State/Province
Misiones
Country
Argentina
Facility Name
Favoloro Hospital
City
Posadas
State/Province
Misiones
Country
Argentina
Facility Name
IPS Hospital
City
Posadas
State/Province
Misiones
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines
We'll reach out to this number within 24 hrs