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Trial record 27 of 40 for:    "Yellow fever"

Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines

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ClinicalTrials.gov Identifier: NCT03368495
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : May 21, 2019
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Ministry of Public Health, Argentina
Information provided by (Responsible Party):
Alba Maria Ropero, Pan American Health Organization

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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 851 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

    1. Allergy to eggs, gelatin, or neomycin
    2. 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
    3. Thymus disease
    4. 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)

Information from the National Library of Medicine

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


Locations
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Argentina
SAMIC Eldorado Hospital
Eldorado, Misiones, Argentina
SAMIC Obera Hospital
Obera, Misiones, Argentina
Favoloro Hospital
Posadas, Misiones, Argentina
IPS Hospital
Posadas, Misiones, Argentina
Sponsors and Collaborators
Alba Maria Ropero
Centers for Disease Control and Prevention
Ministry of Public Health, Argentina
Investigators
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Principal Investigator: Cristian Biscayart, MD Minsterio de Salud de la Nacion, Argentina

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Responsible Party: Alba Maria Ropero, Regional Advisor, Immunization Unit, Pan American Health Organization
ClinicalTrials.gov Identifier: NCT03368495     History of Changes
Other Study ID Numbers: PAHO-2014-07-0011
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alba Maria Ropero, Pan American Health Organization:
yellow fever vaccine
MMR vaccine
immunogenicity

Additional relevant MeSH terms:
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Yellow Fever
Rubella
Rubivirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
Hemorrhagic Fevers, Viral
Vaccines
Immunologic Factors
Physiological Effects of Drugs