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Virus Therapy

RSV Vaccine for Respiratory Syncytial Virus

Phase 1 & 2
Recruiting
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 57 and day 85
Awards & highlights

Study Summary

This trial tests if a vaccine is safe and effective in babies and toddlers 6-24mo to prevent RSV infection.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, live-attenuated vaccines like RSVt can sometimes cause mild symptoms similar to the infection they protect against (like runny nose or cough), as well as potential allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 57 and day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 57 and day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Geometric Mean Titers (GMTs) of vaccine virus shedding
Number of differences detected in genetic sequence of NS2 segment
Presence of vaccine virus
Secondary outcome measures
GMTs of RSV serum anti-F Immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) antibody titers up to 28 days after the second administration (D01, D57, and D85)
Geometric Mean Titers (GMTs) of RSV A serum neutralizing antibody (nAb) titers
Presence of adverse events of special interest (AESIs)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RSVt Vaccine GroupExperimental Treatment1 Intervention
2 intranasal administrations (56 days apart) of the RSVt vaccine at D01 and D57
Group II: Control GroupPlacebo Group1 Intervention
2 intranasal administrations (56 days apart) of the placebo at D01 and D57

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
407 Previous Clinical Trials
6,091,881 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi Pasteur, a Sanofi Company
862 Previous Clinical Trials
2,019,738 Total Patients Enrolled

Media Library

RSVt Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05687279 — Phase 1 & 2
Respiratory Syncytial Virus Research Study Groups: RSVt Vaccine Group, Control Group
Respiratory Syncytial Virus Clinical Trial 2023: RSVt Vaccine Highlights & Side Effects. Trial Name: NCT05687279 — Phase 1 & 2
RSVt Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05687279 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations in this state are hosting the research?

"At present, this project is taking place over 6 different sites. Norfolk, San Juan and Bayamón are just a few of the cities that have been chosen for data collection. To minimize transport costs or any other complications related to travel, it may be best to select a study site in close proximity."

Answered by AI

How many persons are receiving treatment in this experiment?

"Affirmative. Information found on clinicaltrials.gov reveals that this experiment was first posted on February 6th 2023 and is actively recruiting participants, aiming for a total of 100 individuals across six locations."

Answered by AI

Are there still active opportunities to participate in this experiment?

"Affirmative. Clinicaltrials.gov hosts data affirming that this investigation has begun actively enrolling candidates since its posting on February 6th, 2023 and subsequent update on August 28th of the same year. A total of 100 patients are being recruited from six different sites."

Answered by AI

Does this clinical trial accept participants of an advanced age?

"The parameters for this medical experiment demand that potential participants are between half a year and two years old. Additionally, 16 trials accommodate minors under the age of 18 while 17 trials accept those 65 or older."

Answered by AI

What are the core aims of this clinical examination?

"Sanofi Pasteur, a subsidiary of the multinational corporation Sanofi, reports that their primary outcome measure for this trial will be presence of vaccine virus from Day 1 to 85. Additionally, they plan on evaluating secondary outcomes such as RSV A serum Nab titers and RSV serum anti-F IgG ELISA antibody titers up until 28 days post second administration; also noting immediate unsolicited systemic adverse events in participants."

Answered by AI

What qualifications must I meet to enroll in this clinical trial?

"This clinical trial is recruiting 100 infants between half a year and two years of age who are diagnosed with respiratory syncytial virus. In order to participate, individuals must also be born at full term or after 27-36 weeks gestation that have since stabilized medically; attend daycare for at least three days per week where they could potentially interact with other children taking part in the study; or live in a household containing another child enrolled in this experiment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)
2023. "Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05687279.
~35 spots leftby Jan 2025
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