Basic Information

Gene symbol F Synonyms None Type of gene protein-coding
Description Fusion protein (F)

GTO ID GTC3347
Trial ID NCT05743881
Disease Respiratory Syncytial Virus Infectious Disease
Altered gene F
Therapeutic/Target gene Therapeutic gene
TherapymRNA vaccine
Treatment mRNA-1345|mRNA-1365
PhasePhase1
Recruitment statusActive, Not Recruiting
TitleA Phase 1, Randomized, Observer-blind, Placebo-controlled, Age De-escalation Study of the Safety, Tolerability, and Immunogenicity of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
Year2023
CountryArgentina|Australia|Canada|Colombia|Latvia|Panama|Poland|South Africa|Spain|United Kingdom|United States
Company sponsorModernaTX, Inc.
Other ID(s)mRNA-1365-P101|2022-502022-41
Vector information
Vectorlipid nanoparticle

Clinical Result

Cohort1: mRNA-1345_8 to <24 months
Administration route intramuscular injection
Dosage mRNA-1345, on Days 1, 57 and 113
Age Child
Cohort2: mRNA-1365_8 to <24 months
Administration route intramuscular injection
Dosage mRNA-1365, on Days 1, 57 and 113
Age Child
Cohort3: Placebo_8 to <24 months
Administration route intramuscular injection
Dosage placebo, on Days 1, 57 and 113.In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113
Age Child
Cohort4: mRNA-1345_5 to <8 months
Administration route intramuscular injection
Dosage mRNA-1345, on Days 1, 57 and 113
Age Child
Cohort5: mRNA-1365_5 to <8 months
Administration route intramuscular injection
Dosage mRNA-1365, on Days 1, 57 and 113
Age Child
Cohort6: Placebo_5 to <8 months
Administration route intramuscular injection
Dosage placebo, on Days 1, 57 and 113.In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113
Age Child

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