Basic Information

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

GTO ID GTC2438
Trial ID NCT04528719
Disease Respiratory Syncytial Virus Infectious Disease
Altered gene F
Therapeutic/Target gene Therapeutic gene
TherapymRNA vaccine
Treatment mRNA-1345
PhasePhase1
Recruitment statusActive, Not Recruiting
TitleA Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Healthy Younger Adults Aged 18 to 49 Years, Women of Child-Bearing Potential Aged 18 to 40 Years, Healthy Older Adults Aged 65 to 79 Years, Japanese Older Adults Aged ≥ 60 Years, and RSV-Seropositive Children Aged 12 to 59 Months
Year2020
CountryUnited States
Company sponsorModernaTX, Inc.
Other ID(s)mRNA-1345-P101
Vector information
Vectorlipid nanoparticle

Clinical Result

Cohort1: Younger Adults_mRNA-1345_Single injection_dose level 3
Administration route intramuscular injection
Dosage mRNA-1345, Single injection, 50 μg
Pts 19
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort2: Younger Adults_mRNA-1345_Single injection_dose level 4
Administration route intramuscular injection
Dosage mRNA-1345, Single injection, 100 μg
Pts 20
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort3: Younger Adults_mRNA-1345_Single injection_dose level 5
Administration route intramuscular injection
Dosage mRNA-1345, Single injection, 200 μg
Pts 20
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort4: Younger Adults_Placebo_Single injection
Administration route intramuscular injection
Pts 15
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort5: Younger Adults_mRNA-1345_three total injections
Administration route intramuscular injection
Dosage mRNA-1345, three total injections, 100 μg
Pts 51
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort6: Younger Adults_Placebo_three total injections
Administration route intramuscular injection
Pts 12
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort7: Older Adults_mRNA-1345_dose level 1
Administration route intramuscular injection
Dosage mRNA-1345, 12.5 μg
Pts 48
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort8: Older Adults_mRNA-1345_dose level 2
Administration route intramuscular injection
Dosage mRNA-1345, 25 μg
Pts 48
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort9: Older Adults_mRNA-1345_dose level 3
Administration route intramuscular injection
Dosage mRNA-1345, 50 μg
Pts 48
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort10: Older Adults_mRNA-1345_dose level 4
Administration route intramuscular injection
Dosage mRNA-1345, 100 μg
Pts 48
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort11: Older Adults_mRNA-1345_dose level 5
Administration route intramuscular injection
Dosage mRNA-1345, 200 μg
Pts 48
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort12: Older Adults_placebo
Administration route intramuscular injection
Pts 60
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort13: Children
Administration route intramuscular injection
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort14: Women of Child-Bearing Potential
Administration route intramuscular injection
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566
Cohort15: Japanese Older Adults
Administration route intramuscular injection
Age Child, Adult, Older_Adult
References PMID: 38298125 | 38385566

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