Detail

Basic Information Clinical Results Relationship Graph

GTO ID	GTC0553
Trial ID	NCT04956575
Disease	Seasonal Influenza
Therapy	mRNA vaccine
Treatment	mRNA-1010
Phase	Phase1\|Phase2
Recruitment status	Completed
Title	A Phase 1/2, Randomized, Stratified, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults 18 Years and Older
Year	2021
Country	United States
Company sponsor	ModernaTX, Inc.
Other ID(s)	mRNA-1010-P101

Vector information

Vector	lipid nanoparticle

Cohort1: Placebo

Administration route	intramuscular injection
Dosage	placebo, on Day 1
Pts	45
Age	Adult, Older_Adult
Adverse reactions	1/45(All-cause mortality); 2/45(Infections and infestations; Metabolism and nutrition disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Renal and urinary disorders)
References	PMID: 37336877

Cohort2: Phase 1/2_mRNA-1010_dose level 5

Administration route	intramuscular injection
Dosage	mRNA-1010, 50 ug, on Day 1
Pts	45
Age	Adult, Older_Adult
Adverse reactions	No serious clinical adverse events
References	PMID: 37336877

Cohort3: Phase 1/2_mRNA-1010_dose level 6

Administration route	intramuscular injection
Dosage	mRNA-1010, 100 ug, on Day 1
Pts	46
Age	Adult, Older_Adult
Adverse reactions	No serious clinical adverse events
References	PMID: 37336877

Cohort4: Phase 1/2_mRNA-1010_dose level 7

Administration route	intramuscular injection
Dosage	mRNA-1010, 200 ug, on Day 1
Pts	44
Age	Adult, Older_Adult
Adverse reactions	0/44(All-cause mortality); 1/44(Injury, poisoning and procedural complications; Psychiatric disorders; Vascular disorders)
References	PMID: 37336877

Cohort5: Phase 2 NH_ Afluria Quadrivalent

Administration route	intramuscular injection
Dosage	Afluria Quadrivalent, 60 ug, on Day 1
Pts	54
Age	Adult, Older_Adult
Adverse reactions	0/54(All-cause mortality); 1/54(Neoplasms benign, malignant and unspecified(incl cysts and polyps))
References	PMID: 37336877

Cohort6: Phase 2 NH_mRNA-1010_dose level 3

Administration route	intramuscular injection
Dosage	mRNA-1010, 25 ug, on Day 1
Pts	150
Age	Adult, Older_Adult
Adverse reactions	0/150(All-cause mortality); 3/150(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders)
References	PMID: 37336877

Cohort7: Phase 2 NH_mRNA-1010_dose level 4

Administration route	intramuscular injection
Dosage	mRNA-1010, 50 ug, on Day 1
Pts	147
Age	Adult, Older_Adult
Adverse reactions	0/147(All-cause mortality); 5/147(Cardiac disorders; Gastrointestinal disorders; Infections and infestations; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Respiratory, thoracic and mediastinal disorders)
References	PMID: 37336877

Cohort8: Phase 2 NH_mRNA-1010_dose level 5

Administration route	intramuscular injection
Dosage	mRNA-1010, 100 ug, on Day 1
Pts	147
Age	Adult, Older_Adult
Adverse reactions	1/147(All-cause mortality); 4/147(Cardiac disorders; Gastrointestinal disorders; Hepatobiliary disorders; Renal and urinary disorders)
References	PMID: 37336877

Cohort9: Phase 2 Extension_Afluria

Administration route	intramuscular injection
Dosage	Afluria Quadrivalent, 60 ug, on Day 1
Pts	51
Age	Adult, Older_Adult
Adverse reactions	0/51(All-cause mortality); 1/51(Injury, poisoning and procedural complications)
References	PMID: 37336877

Cohort10: Phase 2 Extension_mRNA-1010_dose level 1

Administration route	intramuscular injection
Dosage	mRNA-1010, 6.25 ug, on Day 1
Pts	50
Age	Adult, Older_Adult
Adverse reactions	1/50(All-cause mortality); 2/50(Injury, poisoning and procedural complications; Musculoskeletal and connective tissue disorders)
References	PMID: 37336877

Cohort11: Phase 2 Extension_mRNA-1010_dose level 2

Administration route	intramuscular injection
Dosage	mRNA-1010, 12.5 ug, on Day 1
Pts	50
Age	Adult, Older_Adult
Adverse reactions	No serious clinical adverse events
References	PMID: 37336877

Cohort12: Phase 2 Extension_mRNA-1010_dose level 3

Administration route	intramuscular injection
Dosage	mRNA-1010, 25 ug, single dose, on Day 1
Pts	49
Age	Adult, Older_Adult
Adverse reactions	No serious clinical adverse events
References	PMID: 37336877

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