The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.
The study consists of 3 parts. Part A of the study was conducted for the 2022-23 influenza season. Part B of the study was conducted in 2023-24 influenza season. Part C of the study will be conducted in 2024-25 influenza season.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
172
Sterile liquid for injection
Sterile suspension for injection
Sterile injectable emulsion
Washington University in St. Louis
St Louis, Missouri, United States
Parts A, B, and C: Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time frame: Up to Day 7 (7 days after vaccination)
Parts A, B, and C: Number of Unsolicited Adverse Events (AEs)
Time frame: Up to Day 28 (28 days after vaccination)
Parts A, B, and C: Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation
Time frame: Day 1 through Day 181
Parts A, B, and C: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay
Time frame: Day 29
Part C: GMT of Anti-Respiratory Syncytial Virus (RSV) Antibodies at Day 29, as Measured by Microneutralization Assay for RSV A and B
Time frame: Day 29
Parts A, B, and C: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay
Time frame: Baseline, Day 29
Part C: GMFR of Anti-RSV Antibodies at Day 29, as Measured by Microneutralization Assay
Time frame: Baseline, Day 29
Parts A, B, and C: Percentage of Participants with Seroresponse at Day 29, as Measured by HAI Assay
Seroresponse is defined as a Day 29 titer \> 1:40 if baseline is \< 1:10 or a minimum 4-fold rise if baseline is \>1:10 in anti-HA antibodies measured by HAI assay.
Time frame: Day 29
Part C: Percentage of Participants with Seroresponse at Day 29, as Measured by RSV Neutralization Assay
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sterile suspension for injection
Sterile liquid for injection
Sterile liquid for injection
Seroresponse is defined as post-baseline titer ≥4-fold if baseline is ≥LLOQ or ≥4×LLOQ if baseline titer is \<LLOQ in neutralizing antibody titers measured by RSV neutralization assay, at Day 29.
Time frame: Day 29
Parts A and B: GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization Assay
Time frame: Days 121 and 181
Part C: GMT of Anti-HA Antibodies at Days 57, 121, and 181, as Measured by HAI Assay or Microneutralization Assay
Time frame: Days 57, 121, and 181
Parts A and B: GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay
Time frame: Baseline, Days 121 and 181
Part C: GMFR of Anti-HA Antibodies at Days 57, 121, and 181, as Measured by HAI Assay or MN Assay
Time frame: Baseline, Days 57, 121, and 181
Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by HAI Assay
Seroresponse is defined as a Day 57, 121, or 181 titer \> 1:40 if baseline is \< 1:10 or a minimum 4-fold rise if baseline is \>1:10 in anti-HA antibodies measured by HAI assay.
Time frame: Days 57, 121, and 181
Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by RSV Neutralization Assay
Seroresponse is defined as post-baseline titer ≥4-fold if baseline is ≥LLOQ or ≥4×LLOQ if baseline titer is \<LLOQ in neutralizing antibody titers measured by RSV neutralization assay, at Days 57, 121, or 181.
Time frame: Days 57, 121, and 181