MedTrace Logo

A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population

NCT07103148 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2440

Last updated 2026-05-06

No results posted yet for this study

Summary

The purpose of this study is to determine whether vYF (investigational vaccine) is safe and can help the body to develop antibodies (immunogenicity) compared with Stamaril vaccine and YF-VAX vaccine (both licensed vaccines) and when they are co-administered with Measles Mumps Rubella (MMR) vaccines in infants aged 11-15 months.

Number of Participants:

A total of 2440 participants is planned to be enrolled in VYF04 study.

Study Arms and Duration:

Eligible participants will be randomized in 2 independent groups (9-24 months, 2-5 years) to receive 1 dose of either vYF or Stamaril or YF-VAX in a 2:1:1 ratio within each age group. An additional group with participants of 11-15 months of age will also receive at the same vaccination visit vYF and a single dose of MMR vaccine.

For the 2nd step (YF booster vaccine administration in a subset), at the Year (Y) 3 visit, a subset of 120 participants of the 9-24 months of age group who did receive a YF vaccine on Day(D) 01 will be invited to join a booster dose assessment (booster dose administered after the Y3 visit blood sample has been taken). Participants aged 11 to 15 months at the time of the concomitant administration of vYF and MMR will not be eligible for receiving a booster dose.

The duration of each participation will be approximately 3 years for all participants (including participants co-administered on D01 with vYF and MMR), and 6 more months post-booster dose administration for the participants enrolled in the booster subset.

Conditions

  • Yellow Fever Immunization

Interventions

BIOLOGICAL

Yellow fever vaccine (live)

Powder and diluent for suspension for injection Subcutaneous

BIOLOGICAL

Yellow fever vaccine (live)

Powder and diluent for suspension for injection Subcutaneous

BIOLOGICAL

Yellow fever vaccine (live)

Powder and diluent for suspension for injection Subcutaneous

BIOLOGICAL

Measles, combinations with mumps and rubella, live attenuated

Powder, lyophilized, for suspension for reconstitution Subcutaneous or intermuscular

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2026-08-08
Completion
2030-03-04
FDA Drug
Yes

Countries

  • Honduras
  • Mexico
  • Panama

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07103148 on ClinicalTrials.gov