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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

851 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-23

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vaccine Response Impaired

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Co-administration of MMR/YF

Participants randomized to this arm will receive both MMR and yellow fever vaccines on Day 0.

Group Type EXPERIMENTAL

Co-administration of MMR/YF

Intervention Type BIOLOGICAL

Both MMR \& yellow fever vaccines administered on Day 0.

MMR followed by YF

Participants randomized to this arm will receive MMR vaccine on Day 0 followed by yellow fever vaccine on Day 28.

Group Type ACTIVE_COMPARATOR

MMR followed by YF

Intervention Type BIOLOGICAL

MMR vaccine administered on Day 0 and yellow fever vaccine administered on Day 28.

YF followed by MMR

Participants randomized to this arm will receive YF vaccine on Day 0 followed by MMR vaccine on Day 28.

Group Type ACTIVE_COMPARATOR

YF followed by MMR

Intervention Type BIOLOGICAL

Yellow fever vaccine administered on Day 0 and MMR vaccine administered on Day 28.

Interventions

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Co-administration of MMR/YF

Both MMR \& yellow fever vaccines administered on Day 0.

Intervention Type BIOLOGICAL

MMR followed by YF

MMR vaccine administered on Day 0 and yellow fever vaccine administered on Day 28.

Intervention Type BIOLOGICAL

YF followed by MMR

Yellow fever vaccine administered on Day 0 and MMR vaccine administered on Day 28.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

12 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes