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

NCT03368495 | Completed Phase 4

• 1 other identifier: PAHO-2014-07-0011
• Study Type: interventional
• Target: 851
• Locations: 1 country
• Sites: 4

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.

Conditions

Vaccine Response Impaired

Keywords

yellow fever vaccine; MMR vaccine; immunogenicity

Outcome Measures

Primary Outcomes (2)

• Seroconversion after yellow fever vaccination using the plaque reduction neutralization test (PRNT).

  PRNTs will be used to measure antibody titers for yellow fever.

  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.

  28-35 days post-vaccination.

Study Arms (3)

Co-administration of MMR/YF

EXPERIMENTAL

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

Biological: Co-administration of MMR/YF

MMR followed by YF

ACTIVE COMPARATOR

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

YF followed by MMR

ACTIVE COMPARATOR

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

Biological: YF followed by MMR

Interventions

Co-administration of MMR/YF BIOLOGICAL

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

Co-administration of MMR/YF

MMR followed by YF BIOLOGICAL

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

MMR followed by YF

YF followed by MMR BIOLOGICAL

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

YF followed by MMR

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Alba Maria Ropero: lead
• Centers for Disease Control and Prevention: collaborator
• Ministry of Public Health, Argentina: collaborator

Study Sites (4)

SAMIC Eldorado Hospital

Eldorado, Misiones Province, Argentina

Location

SAMIC Obera Hospital

Oberá, Misiones Province, Argentina

Location

Favoloro Hospital

Posadas, Misiones Province, Argentina

Location

IPS Hospital

Posadas, Misiones Province, Argentina

Location

Related Publications (1)

• Vizzotti C, Harris JB, Aquino A, Rancano C, Biscayart C, Bonaventura R, Pontoriero A, Baumeister E, Freire MC, Magarinos M, Duarte B, Grant G, Reef S, Laven J, Wannemuehler KA, Alvarez AMR, Staples JE. Immune response to co-administration of measles, mumps, and rubella (MMR), and yellow fever vaccines: a randomized non-inferiority trial among one-year-old children in Argentina. BMC Infect Dis. 2023 Mar 17;23(1):165. doi: 10.1186/s12879-023-08114-1.

  PMID: 36932346 DERIVED

Study Officials

• Cristian Biscayart, MD

  Minsterio de Salud de la Nacion, Argentina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Regional Advisor, Immunization Unit

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 11, 2017
• Study Start: November 23, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 30, 2018
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

AR (4)