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RSV Vaccines for Respiratory Syncytial Virus
Study Summary
This trial will evaluate the safety and effectiveness of three different RSV vaccines in young children.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- I tested negative for RSV antibodies recently.My heart condition is minor and doesn't need treatment.My child shares a daycare room with infants under 4 months, and I can't keep them home for 14 days after the study product is given.I do not have a fever, severe cold symptoms, or an ear infection currently.I am up to date with all vaccinations recommended for my age.My blood test shows I don't have enough antibodies to fight RSV.Someone in my house has a long-term lung problem, but hasn't been hospitalized for asthma or taken oral steroids for it in the past month.If I'm chosen for the study but later found ineligible, my treatment will be paused.I am between 6 months and less than 25 months old.I have received a bone marrow or organ transplant.I haven't received any blood products or antibodies in the last 6 months.I was born to an HIV-infected mother and have tested negative for HIV.I have HIV or my immune system does not work properly.I am between 6 months and less than 25 months old.I haven't received any vaccines or investigational drugs in the last 28 days.I do not have major birth defects or genetic abnormalities.I have used supplemental oxygen at home before.I haven't taken antibiotics, antivirals, antifungals, anti-parasitics, antituberculous agents, or intranasal meds in the last 3 days.I am in good health with no chronic diseases.I am only using allowed medications like supplements and topical treatments.My child was born slightly early and is under 1 year old.I haven't taken any immunosuppressive drugs, including steroids, in the last 28 days.I am not planning to receive certain vaccines or investigational drugs soon after the study product.I live with someone who is immunocompromised due to cancer treatment or organ transplant.I am up to date with all vaccinations recommended for my age.I have not previously participated in this trial or received any RSV vaccines or treatments.I have a history of lung problems, including wheezing.
- Group 1: RSV ΔNS2/Δ1313/I1314L Vaccine
- Group 2: RSV 6120/ΔNS2/1030s Vaccine
- Group 3: RSV 276 Vaccine
- Group 4: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is eligibility for this study limited to those aged 60 or under?
"This medical trial is recruiting patients aged between half a year and two years old. Additionally, there are 51 studies available to those under 18 while 88 exist for people over 65."
In what Canadian sites is this investigation being conducted?
"Currently, 15 trial sites are operational. These include Aurora, Baltimore and Stony Brook with an additional 12 locations spread across the country. To reduce necessary travel for participation in this study it is wise to choose a site close to your home."
What is the estimated participant count for this clinical trial?
"Correct. According to clinicaltrials.gov, this medical research project is presently in need of participants - first posted on May 16th 2019 and last updated November 21st 2022. 160 volunteers are needed across 15 trial sites."
What are the chief aims of this investigation?
"The primary measure of this trial, judged on Day 56, is the rate of Grade 1 or higher adverse events. Secondary metrics include serum RSV F IgG titer (determined through immunologic assessment), maximum grade of RSV-MAALRI illness (following a protocol-defined grading system for solicited events) and frequency of medically attended acute lower respiratory illnesses associated with RSV (also graded according to the same criteria)."
For which demographic is this research endeavor suitable?
"For inclusion in this study, applicants must have been diagnosed with Respiratory Syncytial Virus and be between 6 to 25 months of age. This trial has a designated recruitment number of 160 participants."
Are there any volunteers being admitted to this research project currently?
"This clinical investigation, which was first published on May 16th 2019, is currently enrolling participants. The listing has been updated most recently on November 21st 2022."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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