RSV Vaccine for Respiratory Syncytial Virus

Recruiting at 11 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi Pasteur, a Sanofi Company

Must not be taking: Immunosuppressants, Corticosteroids, Aspirin, others

Disqualifiers: Immunodeficiency, Chronic illness, COVID-19, others

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to \< 24 months of age.

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi Pasteur, a Sanofi Company

Are You a Good Fit for This Trial?

This trial is for healthy infants and toddlers aged 6 to less than 24 months who attend daycare or have a sibling in the same age range. They must be born at full term or stable if premature, without significant medical support needs. Children with severe allergies, recent fevers, immunodeficiencies, contact with immunocompromised individuals, or recent receipt of certain vaccines and medications are excluded.

Inclusion Criteria

Participants who are healthy as determined by medical evaluation including medical history

Born at full term of pregnancy (≥ 37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator

I go to a daycare with kids my age for at least 3 days and 4 hours each day.

Exclusion Criteria

I have never received an experimental RSV vaccine or treatment.

Attends a daycare facility with infants less than 6 months of age and unable or unwilling to suspend attendance for 28 days following study intervention

Deprived of freedom in an emergency setting or hospitalized involuntarily

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 intranasal administrations of the RSVt vaccine or placebo, 56 days apart

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 6-month safety follow-up phone call

6 months

What Are the Treatments Tested in This Trial?

Interventions

• RSVt Vaccine

Trial Overview The study tests a live-attenuated RSVt vaccine given intranasally to see how it spreads among close contacts and whether its genetic makeup remains stable after vaccination. The control group does not receive this vaccine. Participants are monitored over two doses administered 56 days apart.

How Is the Trial Designed?

Group I: RSVt Vaccine Group Experimental Treatment 1 Intervention

2 intranasal administrations (56 days apart) of the RSVt vaccine at D01 and D57

Group II: Control Group Placebo Group 1 Intervention

2 intranasal administrations (56 days apart) of the placebo at D01 and D57

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences