Could a Lower-Dose RSV vaccine protect babies just as well?
NCT ID NCT06705140
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This study tested a nasal spray RSV vaccine in nearly 1,000 healthy infants and toddlers aged 6 to 22 months. The goal was to see if a lower dose works as well as the standard dose and to check safety across different doses. The trial was ended early, so final results are not available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
42 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
-
Jun 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 to 21 months
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 6 months to \< 22 months on the day of inclusion (means from the day of the 6-month birthday to the day before the 22-month birthday. The second vaccine administration was administered before the study participant has turned 24 months of age). * Participants who were healthy as determined by medical evaluation including medical history. * For Cohort 1 and Cohort 2 (contingent upon satisfactory safety profile of the RSVt vaccine in Cohort 1): --Participant born 28 through 36 weeks of gestation 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. * For Cohort 2: * Participant born at full term of pregnancy (≥ 37 weeks of gestation). Exclusion Criteria: Participants were excluded from the study if any of the following criteria apply: * 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). * 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. Children with a history of recurrent wheezing will be excluded. Children with a previous single episode of wheezing may be included if that episode of wheezing was not associated with hospitalization or if does not have a family history of 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. * 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 the first study intervention administration, any other injectable live attenuated vaccines within the 28 days prior to and after. Concomitant receipt on the day of the first study intervention administration is allowed * Planned receipt of any monoclonal antibody for RSV (such as Nirsevimab or Palivizumab) for the duration of the study. * 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 Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Investigational Site Number : 3400001
Tegucigalpa, 11101, Honduras
-
Investigational Site Number : 3400002
San Pedro Sula, Honduras
-
Investigational Site Number : 3400003
Tegucigalpa, 11101, Honduras
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Comparative effects of three breathing techniques on heart rate variability, attention, reaction time, and anxiety in healthy adults: a randomized controlled trial
- An Open-Label phase 1 study to assess the safety, tolerability, and pharmacokinetics of a single dose of a new tablet formulation of TRTL-729 in healthy adults
- A phase 2b, randomized, placebo-controlled, observer-blind study in adults 60 years of age and older to evaluate the efficacy, safety, and immunogenicity of a bivalent protein vaccine candidate against respiratory syncytial virus (RSV) and human metapneumovirus (HMPV)
- THERMOS-LUNCH: effects of meals differing in nutritional quality and environmental footprint on postprandial metabolism, Diet-Induced thermogenesis, respiratory quotient, satiety, and hydration status in healthy young men
- Phase i clinical study, open-label, randomized, parallel to evaluate the safety of the 200 mg dexibuprofen following single and multiple dose oral administration in healthy participants of both sexes under fasting and fed conditions.
- Can a copycat humira match the original?