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Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
EU CTIS ID: 2023-505762-29-00
What this study is testing
To demonstrate the clinical efficacy of RSVt vaccine for the prevention of reverse transcription polymerase chain reaction (RT PCR) confirmed RSV lower respiratory tract disease (LRTD) after 2 doses, over RSV Season 1
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 6 months to < 22 months on the day of inclusion (means the day of the 6-month birthday to the day before the 22-month birthday)
- Participants who are healthy as determined by medical evaluation including medical history
- Born at full term of pregnancy (≥ 37 weeks)
You likely can't join if
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation 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)
- Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration: • Any other intranasal live attenuated vaccine within the 28 days prior to and after Dose 1 study administration • Unless given on the day of Dose 1 study administration, any other injectable live attenuated vaccines within the 28 days prior to and after. Concomitant receipt on the day of Dose 1 study administration is allowed.
- Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin) at the time of enrollment. Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment
- Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
See the full eligibility criteria
Who can join
- Aged 6 months to < 22 months on the day of inclusion (means the day of the 6-month birthday to the day before the 22-month birthday)
- Participants who are healthy as determined by medical evaluation including medical history
- Born at full term of pregnancy (≥ 37 weeks)
What rules you out
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation 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)
- Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration: • Any other intranasal live attenuated vaccine within the 28 days prior to and after Dose 1 study administration • Unless given on the day of Dose 1 study administration, any other injectable live attenuated vaccines within the 28 days prior to and after. Concomitant receipt on the day of Dose 1 study administration is allowed.
- Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin) at the time of enrollment. Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment
- Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- History of medically diagnosed wheezing
- Any acute febrile illness in the past 48 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- Probable or confirmed ongoing case of viral respiratory infection (including COVID-19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved.
- Member of a household that contains an immunocompromised individual, including, but not limited to: • a person who is HIV infected • a person who has received chemotherapy within the 12 months prior to study enrollment • a person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents • a person living with a solid organ or bone marrow transplant
- Potential close contact with other immunocompromised individual within 30 days after each vaccination as per investigator’s discretion
- Participant’s biological mother’s previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Kenya
- South Africa
- China
- Honduras
- Japan
- Colombia
- Argentina
- India
- Brazil
- United States
- Korea, Republic of
- Nepal
- Thailand
- Puerto Rico
- United Kingdom
- Chile
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Kenya; South Africa; China; Honduras; Japan and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.