About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 9 months to 5 years on the day of inclusion*

Aged 11 to 15 months* on the day of inclusion for participants enrolled in the MMR co-administration group

Participants who are healthy as determined by medical evaluation including medical history and physical examination

For infants*, born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention

Disqualifiers

Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy irradiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

Known history of FV infection

Known systemic hypersensitivity to any of the study intervention components, eggs or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances

Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.

Trial design

Design model

Parallel

Treatments tested in this trial

Yellow fever vaccine (live)
Biological/Vaccine
Powder and diluent for suspension for injection Subcutaneous
Yellow fever vaccine (live)
Biological/Vaccine
Powder and diluent for suspension for injection Subcutaneous
Yellow fever vaccine (live)
Biological/Vaccine
Powder and diluent for suspension for injection Subcutaneous
Measles, combinations with mumps and rubella, live attenuated
Biological/Vaccine
Powder, lyophilized, for suspension for reconstitution Subcutaneous or intermuscular

Treatment groups

2,440 Participants

are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Group 1 (9-24 months)Experimental treatment 1 intervention

Group B: Group 2 (9-24 months)Active comparator 1 intervention

Group C: Group 3 (9-24 months)Active comparator 1 intervention

Group D: Group 4 (2-5 years)Experimental treatment 1 intervention

Group E: Group 5 (2-5 years)Active comparator 1 intervention

Group F: Group 6 (2-5 years)Active comparator 1 intervention

Group G: Group 7 (approximately 11-15 months)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants with seroconversion to YF virus after 1 dose of vYF compared to seroconversion after 1 dose of the Stamaril in YF-naive participants (9-24 months)