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.
The duration of each participant's participation is up to 8 months, including the 6 months safety follow-up phone call after the second study intervention administration for the pediatric participants The treatment administration for the pediatric participants will be on D01 and D57 (1 intranasal administration each).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal
Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal
Meridian Clinical Research Norfolk Site Number : 8400003
Norfolk, Nebraska, United States
Velocity Clinical Research, Omaha Site Number : 8400001
Omaha, Nebraska, United States
Investigational Site Number : 6300004
Bayamón, Puerto Rico
Investigational Site Number : 6300002
Carolina, Puerto Rico
Percentage of Placebo Receiving Pediatric Participants With Vaccine Virus Detected in Nasal Swabs After the First Vaccination
Nasal swabs were collected to assess the presence of vaccine virus after first vaccination. Vaccine virus transmission was defined as presence of detected vaccine virus confirmed by RSVt quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay (vaccine virus shedding \>=lower limit of detection \[LOD=2.80 log10 copies/mL\]) in pediatric participants receiving placebo. Percentages are rounded off to the tenth decimal place.
Time frame: Pre-vaccination on Day 1 and post-vaccination on Days 4, 8, 11, 15, 18 and 22
Titer of Vaccine Virus Shedding in All Pediatric Participants Detected in Nasal Swabs
Nasal swabs were collected to assess the shedding of the attenuated RSV vaccine strain and quantified by RSVt qRT PCR assay. Quantified virus shedding was defined as vaccine virus shedding \>=lower limit of quantification (LLOQ=3.37 log10 copies/mL).
Time frame: Pre-vaccination on Day 1 and post-vaccination on Days 4, 8, 11, 15, 18, 22, 64 and 71
Percentage of Placebo Receiving Pediatric Participants With Detected Shedding Who Showed Any Genetic Sequence Variation After Each Vaccination
Nasal swabs were collected to identify the difference in genetic sequence of mutated vaccine virus segments compared to the reference strain vaccine virus isolates in the vaccine virus positive swabs from pediatric participants receiving placebo after each vaccination. Detected virus shedding was defined as vaccine virus shedding \>=LOD (2.80 log10 copies/mL).
Time frame: Up to 21 days after each vaccination (Day 1 to Day 22 and Day 57 to Day 78)
Geometric Mean Titers (GMTs) of RSV A Serum Neutralizing Antibody (nAb) Titers
Serum samples were collected at specified timepoints for immunogenicity assessments. RSV A serum neutralizing antibody titers were evaluated by microneutralization (MN) assay.
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Investigational Site Number : 6300003
Guayama, Puerto Rico
Investigational Site Number : 6300001
San Juan, Puerto Rico
Time frame: Pre-vaccination on Day 1 (first vaccination) and Day 57 (second vaccination) and up to 28 days after second vaccination, Day 85
Secondary: Geometric Mean Titers of RSV Serum Anti-F Immunoglobulin G (IgG) Enzyme-linked Immuno-adsorbant Assay (ELISA) Antibody
Serum samples were collected at specified timepoints for immunogenicity assessments. Antibodies to RSV F antigen were measured using the anti RSV F IgG ELISA method.
Time frame: Pre-vaccination on Day 1 (first vaccination) and Day 57 (second vaccination) and up to 28 days after second vaccination, Day 85
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after each vaccination and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs.
Time frame: Up to 30 minutes after each vaccination (Days 1 and 57)
Number of Participants With Solicited Administration Site Reactions and Systemic Reactions
A solicited reaction was an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as related to the study vaccine administered. An administration site reaction was an AR at and around the administration/injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the vaccine even if there was evidence of alternative etiology.
Time frame: Up to 21 days after each vaccination (Day 1 to Day 22 and Day 57 to Day 78)
Number of Participants With Unsolicited Adverse Events
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Time frame: Up to 28 days after each vaccination (Day 1 to Day 29 and Day 57 to Day 85)