Seasonal Influenza
Conditions
Keywords
Influenza vaccine, mRNA-1010, Moderna
Brief summary
The study comprises 3 parts: Phase 1/2, Phase 2 Northern Hemisphere (NH), and Phase 2 extension. The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1010 vaccine.
Interventions
BIOLOGICALmRNA-1010
Sterile liquid for injection
BIOLOGICALPlacebo
0.9% sodium chloride solution for injection
BIOLOGICALActive Comparator
0.5 milliliter (mL) intramuscular (IM) injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: Phase 1/2: * Participant has a body mass index (BMI) of 18 kilograms (kg)/square meter (m\^2) to 35 kg/m\^2 (inclusive) at the Screening Visit. * Participant is in good health, in the opinion of the Investigator, based on review of medical history and physical examination performed at screening. * For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding. Phase 2 NH and Phase 2 Extension: * Participant is medically stable, in the opinion of the Investigator, based on review of medical history and physical examination performed at screening. * For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding. Key
Exclusion criteria
Phase 1/2: * Participant has had significant exposure to someone with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, COVID-19, or influenza-like illness (ILI) in the past 14 days prior to the Screening Visit, as defined by the United States Centers for Disease Control and Prevention (CDC) as close contact with someone who has COVID-19. * Participant has a positive SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) or antigen test in the past 10 days prior to the Screening Visit. * Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1. * Participant has a pre-existing medical condition that is not stable, at the discretion of the Investigator. * Participant has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment. * Participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screening Visit (for corticosteroids ≥10 milligrams \[mg\]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. * Participant has received or plans to receive any licensed vaccine ≤28 days prior to the investigational product (IP) injection (Day 1) or plans to receive a licensed vaccine within 28 days after the IP injection, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of type of vaccine) that become available to participants during the study. Efforts should be made to space study vaccination and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed. * Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine after 01 January 2021. Phase 2 NH: * Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the CDC (CDC 2021a) in the past 14 days prior to the Screening Visit, unless the participant has been fully vaccinated for COVID-19. * Participant is acutely ill or febrile (body temperature ≥ 38.0°C/100.4°F) 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window and will retain their initially assigned participant number. * Participant has a medical, psychiatric, occupational condition, or history of substance abuse that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment. * Participant has a current or previous diagnosis of immunocompromising/immunosuppressive condition, immune mediated disease requiring immune-modifying therapy, asplenia, recurrent severe infections (human immunodeficiency virus \[HIV\] positive participants on antiretroviral therapy with cluster of differentiation \[CD\] 4 count ≥ 350 cells/mm3 and HIV RNA ≤ 500 copies/mL within the past 12 months are permitted). * Participant has received systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to Screening Visit (for corticosteroids ≥ 10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. * Participant has a history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or any of the components contained in the mRNA 1010 or the comparator vaccine, which is an egg-based influenza vaccine. * Participant has received or plans to receive any licensed vaccine ≤ 28 days prior to the IP injection (Day 1) or plans to receive a licensed vaccine within 28 days after the IP injection, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of type of vaccine) that become available to participants during the study. Efforts should be made to space study vaccination and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed. * Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 6 months prior to the Screening Visit. * Participant has tested positive for influenza by CDC-recommended testing methods within 6 months prior to the Screening Visit. * Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study. Phase 2 Extension: * Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the CDC in the past 10 days prior to the Screening Visit. * Participant is acutely ill or febrile (body temperature ≥ 38.0°C/100.4°F) 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window and will retain their initially assigned participant number. * Participant has a medical, psychiatric, occupational condition, or history of substance abuse that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment. * Participant has a current or previous diagnosis of immunocompromising/immunosuppressive condition, immune-mediated disease requiring immune-modifying therapy, asplenia, recurrent severe infections (HIV-positive participants on antiretroviral therapy with CD 4 count ≥ 350 cells/mm\^3 and HIV-RNA ≤ 500 copies/mL within the past 365 days are permitted). * Participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 180 days prior to Screening Visit (for corticosteroids ≥ 10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. * Participant has a history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or any of the components contained in the mRNA-1010 or the comparator vaccine, which is an egg-based influenza vaccine. * Participant has received or plans to receive any licensed vaccine ≤ 28 days prior to the IP injection (Day 1) or plans to receive a licensed vaccine within 28 days after the IP injection, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of type of vaccine) that become available to participants during the study. Efforts should be made to space study vaccination and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed. * Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to the randomization visit. * Participant had tested positive for influenza by CDC-recommended testing methods within 180 days prior to the Screening Visit. * Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study. Other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Day 29 | Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if LLOQ was 1:10, a post-baseline titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was \>1:10, a post-baseline titer ≥4 x LLOQ if baseline was \<LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies. 95% CI was calculated using the Clopper-Pearson method |
| Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 29 | Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. |
| Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 29 | Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. |
| Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Day 29 | Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if lower limit of quantification (LLOQ) was 1:10, a post-baseline titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was \>1:10, a post-baseline titer ≥4 x LLOQ if baseline was \<LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies. |
| Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline), Day 29 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. |
| Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Day 29 | Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if LLOQ was 1:10, a post-baseline titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was \>1:10, a post-baseline titer ≥4 x LLOQ if baseline was \<LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies. 95% CI was calculated using the Clopper-Pearson method |
| Number of Participants With Solicited Local and Systemic ARs | 7 days after vaccination | Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Solicited ARs (local and systemic) considered causally related to injection were graded 0-4; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. Summary of serious AEs (SAEs) and nonserious AEs (Other), regardless of causality, is in Reported Adverse Events section and presented by Phase/dose group. |
| Number of Participants With Unsolicited AEs | Up to 28 days after vaccination | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs (Other) reported up to the end of the study, regardless of causality, is located in the Reported Adverse Events section and presented by each Phase and dose group separately. |
| Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | Up to 6 months (end of study) | An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that leads to an unscheduled visit to an healthcare practitioner. This would include visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). A summary of SAEs and all nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section and presented by each Phase and dose group separately. |
| Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 29 | Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline), Day 8 and Day 181 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the difference in the log-transformed values for GMT, then back transformed to the original scale for presentation. |
| Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Day 29 | — |
| Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Day 29 | Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if lower limit of quantification (LLOQ) was 1:10, a post-baseline titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was \>1:10, a post-baseline titer ≥4 x LLOQ if baseline was \<LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies. |
| Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 29 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. |
| Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline), Day 8 and Day 181 | Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 20 centers in the United States. The vaccines used in the study were based on the influenza virus strains recommended by the World Health Organization for the southern and northern hemispheres.
Pre-assignment details
For Phase 1/2, 1 participant who was randomly assigned to the 200 micrograms (ug) mRNA-1010 group received a dose of 100 ug and was therefore included in the 100 ug mRNA-1010 group in the Safety Set and the Solicited Safety Set. For Phase 2 Northern Hemisphere (NH), 1 participant randomly assigned to the 25 ug mRNA-1010 group received 50 ug mRNA-1010, and 1 participant randomly assigned to 50 ug mRNA-1010 received Afluria Quadrivalent.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1/2: Placebo Participants received placebo matching to mRNA-1010 by IM injection on Day 1. | 45 |
| Phase 1/2: mRNA-1010 50 ug Participants received mRNA-1010 50 ug by IM injection on Day 1. | 45 |
| Phase 1/2: mRNA-1010 100 ug Participants received mRNA-1010 100 ug by IM injection on Day 1. | 46 |
| Phase 1/2: mRNA-1010 200 ug Participants received mRNA-1010 200 ug by IM injection on Day 1. | 44 |
| Phase 2 NH: Afluria Quadrivalent 60 ug Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1. | 54 |
| Phase 2 NH: mRNA-1010 25 ug Participants received mRNA-1010 25 ug by IM injection on Day 1. | 150 |
| Phase 2 NH: mRNA-1010 50 ug Participants received mRNA-1010 50 ug by IM injection on Day 1. | 147 |
| Phase 2 NH: mRNA-1010 100 ug Participants received mRNA-1010 100 ug by IM injection on Day 1. | 147 |
| Phase 2 Extension: Afluria Quadrivalent 60 ug Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1 | 51 |
| Phase 2 Extension: mRNA-1010 6.25 ug Participants received mRNA-1010 6.25 ug by IM injection on Day 1. | 50 |
| Phase 2 Extension: mRNA-1010 12.5 ug Participants received mRNA-1010 12.5 ug by IM injection on Day 1. | 50 |
| Phase 2 Extension: mRNA-1010 25 ug Participants received mRNA-1010 25 ug by IM injection on Day 1. | 49 |
| Total | 878 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 4 | 2 | 3 | 1 | 10 | 11 | 7 | 4 | 2 | 3 | 8 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 1 | 4 | 2 | 8 | 5 | 1 | 1 | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | Phase 1/2: Placebo | Phase 1/2: mRNA-1010 50 ug | Phase 1/2: mRNA-1010 100 ug | Phase 1/2: mRNA-1010 200 ug | Phase 2 NH: Afluria Quadrivalent 60 ug | Phase 2 NH: mRNA-1010 25 ug | Phase 2 NH: mRNA-1010 50 ug | Phase 2 NH: mRNA-1010 100 ug | Phase 2 Extension: Afluria Quadrivalent 60 ug | Phase 2 Extension: mRNA-1010 6.25 ug | Phase 2 Extension: mRNA-1010 12.5 ug | Phase 2 Extension: mRNA-1010 25 ug | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 52.0 years | 48.2 years | 52.2 years | 48.9 years | 52.4 years | 50.4 years | 50.3 years | 49.9 years | 40.8 years | 40.4 years | 42.8 years | 38.9 years | 47.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 12 Participants | 9 Participants | 8 Participants | 12 Participants | 27 Participants | 32 Participants | 29 Participants | 17 Participants | 12 Participants | 14 Participants | 11 Participants | 188 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 33 Participants | 37 Participants | 35 Participants | 42 Participants | 122 Participants | 114 Participants | 114 Participants | 34 Participants | 36 Participants | 35 Participants | 36 Participants | 677 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 13 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 12 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 5 Participants | 2 Participants | 10 Participants | 6 Participants | 17 Participants | 18 Participants | 18 Participants | 4 Participants | 4 Participants | 8 Participants | 4 Participants | 101 Participants |
| Race/Ethnicity, Customized Multiple Race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 11 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other Race | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Not Reported | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 38 Participants | 38 Participants | 41 Participants | 32 Participants | 45 Participants | 124 Participants | 120 Participants | 124 Participants | 47 Participants | 44 Participants | 39 Participants | 41 Participants | 733 Participants |
| Sex: Female, Male Female | 23 Participants | 19 Participants | 25 Participants | 33 Participants | 30 Participants | 89 Participants | 80 Participants | 86 Participants | 24 Participants | 34 Participants | 27 Participants | 30 Participants | 500 Participants |
| Sex: Female, Male Male | 22 Participants | 26 Participants | 21 Participants | 11 Participants | 24 Participants | 61 Participants | 67 Participants | 61 Participants | 27 Participants | 16 Participants | 23 Participants | 19 Participants | 378 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 45 | 0 / 45 | 0 / 46 | 0 / 44 | 0 / 54 | 0 / 150 | 0 / 147 | 1 / 147 | 0 / 51 | 1 / 50 | 0 / 50 | 0 / 49 |
| other Total, other adverse events | 26 / 45 | 39 / 45 | 44 / 46 | 42 / 44 | 37 / 54 | 130 / 150 | 133 / 147 | 133 / 147 | 33 / 51 | 45 / 50 | 38 / 50 | 45 / 49 |
| serious Total, serious adverse events | 2 / 45 | 0 / 45 | 0 / 46 | 1 / 44 | 1 / 54 | 3 / 150 | 5 / 147 | 4 / 147 | 1 / 51 | 2 / 50 | 0 / 50 | 0 / 49 |
Outcome results
Primary
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs)
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that leads to an unscheduled visit to an healthcare practitioner. This would include visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). A summary of SAEs and all nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section and presented by each Phase and dose group separately.
Time frame: Up to 6 months (end of study)
Population: Safety Analysis Set: all randomly assigned participants who received the investigational product. Dose groups for Phase 1/2, Phase 2 NH, and Phase 2 Extension by dose group and Afluria Quadrivalent 60 ug groups were combined for this assessment as pre-specified by the protocol. Combined data for \>= 50 ug is also presented. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | MAAE | 10 Participants |
| Placebo | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | SAE | 2 Participants |
| Placebo | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | AESI | 0 Participants |
| Afluria Quadrivalent 60 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | SAE | 2 Participants |
| Afluria Quadrivalent 60 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | MAAE | 27 Participants |
| Afluria Quadrivalent 60 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | AESI | 0 Participants |
| mRNA-1010 6.25 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | AESI | 0 Participants |
| mRNA-1010 6.25 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | SAE | 2 Participants |
| mRNA-1010 6.25 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | MAAE | 18 Participants |
| mRNA-1010 12.5 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | MAAE | 15 Participants |
| mRNA-1010 12.5 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | SAE | 0 Participants |
| mRNA-1010 12.5 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | AESI | 0 Participants |
| mRNA-1010 25 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | SAE | 3 Participants |
| mRNA-1010 25 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | AESI | 0 Participants |
| mRNA-1010 25 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | MAAE | 58 Participants |
| mRNA-1010 50 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | AESI | 0 Participants |
| mRNA-1010 50 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | SAE | 5 Participants |
| mRNA-1010 50 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | MAAE | 50 Participants |
| mRNA-1010 100 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | MAAE | 62 Participants |
| mRNA-1010 100 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | SAE | 4 Participants |
| mRNA-1010 100 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | AESI | 0 Participants |
| mRNA-1010 200 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | AESI | 0 Participants |
| mRNA-1010 200 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | MAAE | 12 Participants |
| mRNA-1010 200 ug | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | SAE | 1 Participants |
| mRNA-1010 >= 50 ug Overall | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | AESI | 0 Participants |
| mRNA-1010 >= 50 ug Overall | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | MAAE | 124 Participants |
| mRNA-1010 >= 50 ug Overall | Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs) | SAE | 10 Participants |
Primary
Number of Participants With Solicited Local and Systemic ARs
Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Solicited ARs (local and systemic) considered causally related to injection were graded 0-4; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. Summary of serious AEs (SAEs) and nonserious AEs (Other), regardless of causality, is in Reported Adverse Events section and presented by Phase/dose group.
Time frame: 7 days after vaccination
Population: Solicited Safety Set: Consisted of all participants in the Safety Set who contributed any solicited AR data. Dose groups for Phase 1/2, Phase 2 NH, and Phase 2 Extension by dose group and Afluria Quadrivalent 60 ug groups were combined for this assessment as pre-specified by the protocol. Combined data for \>= 50 ug is also presented. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Solicited Local and Systemic ARs | Grade 3 | 1 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic ARs | Grade 4 | 0 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic ARs | Grade 2 | 5 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic ARs | Grade 1 | 12 Participants |
| Afluria Quadrivalent 60 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 1 | 43 Participants |
| Afluria Quadrivalent 60 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 4 | 0 Participants |
| Afluria Quadrivalent 60 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 2 | 16 Participants |
| Afluria Quadrivalent 60 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 3 | 4 Participants |
| mRNA-1010 6.25 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 2 | 17 Participants |
| mRNA-1010 6.25 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 4 | 0 Participants |
| mRNA-1010 6.25 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 1 | 22 Participants |
| mRNA-1010 6.25 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 3 | 4 Participants |
| mRNA-1010 12.5 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 1 | 16 Participants |
| mRNA-1010 12.5 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 2 | 12 Participants |
| mRNA-1010 12.5 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 4 | 0 Participants |
| mRNA-1010 12.5 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 3 | 4 Participants |
| mRNA-1010 25 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 1 | 76 Participants |
| mRNA-1010 25 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 3 | 15 Participants |
| mRNA-1010 25 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 2 | 81 Participants |
| mRNA-1010 25 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 4 | 0 Participants |
| mRNA-1010 50 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 4 | 0 Participants |
| mRNA-1010 50 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 1 | 65 Participants |
| mRNA-1010 50 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 2 | 70 Participants |
| mRNA-1010 50 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 3 | 31 Participants |
| mRNA-1010 100 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 3 | 45 Participants |
| mRNA-1010 100 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 1 | 44 Participants |
| mRNA-1010 100 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 2 | 86 Participants |
| mRNA-1010 100 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 4 | 0 Participants |
| mRNA-1010 200 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 2 | 17 Participants |
| mRNA-1010 200 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 3 | 18 Participants |
| mRNA-1010 200 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 1 | 7 Participants |
| mRNA-1010 200 ug | Number of Participants With Solicited Local and Systemic ARs | Grade 4 | 0 Participants |
| mRNA-1010 >= 50 ug Overall | Number of Participants With Solicited Local and Systemic ARs | Grade 4 | 0 Participants |
| mRNA-1010 >= 50 ug Overall | Number of Participants With Solicited Local and Systemic ARs | Grade 1 | 116 Participants |
| mRNA-1010 >= 50 ug Overall | Number of Participants With Solicited Local and Systemic ARs | Grade 2 | 173 Participants |
| mRNA-1010 >= 50 ug Overall | Number of Participants With Solicited Local and Systemic ARs | Grade 3 | 94 Participants |
Primary
Number of Participants With Unsolicited AEs
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs (Other) reported up to the end of the study, regardless of causality, is located in the Reported Adverse Events section and presented by each Phase and dose group separately.
Time frame: Up to 28 days after vaccination
Population: Safety Analysis Set: all randomly assigned participants who received the investigational product. Dose groups for Phase 1/2, Phase 2 NH, and Phase 2 Extension by dose group and Afluria Quadrivalent 60 ug groups were combined for this assessment as pre-specified by the protocol. Combined data for \>= 50 ug is also presented. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Unsolicited AEs | All | 6 Participants |
| Placebo | Number of Participants With Unsolicited AEs | Nonserious | 5 Participants |
| Placebo | Number of Participants With Unsolicited AEs | Serious | 1 Participants |
| Afluria Quadrivalent 60 ug | Number of Participants With Unsolicited AEs | Nonserious | 20 Participants |
| Afluria Quadrivalent 60 ug | Number of Participants With Unsolicited AEs | Serious | 0 Participants |
| Afluria Quadrivalent 60 ug | Number of Participants With Unsolicited AEs | All | 20 Participants |
| mRNA-1010 6.25 ug | Number of Participants With Unsolicited AEs | Serious | 1 Participants |
| mRNA-1010 6.25 ug | Number of Participants With Unsolicited AEs | All | 17 Participants |
| mRNA-1010 6.25 ug | Number of Participants With Unsolicited AEs | Nonserious | 16 Participants |
| mRNA-1010 12.5 ug | Number of Participants With Unsolicited AEs | Nonserious | 14 Participants |
| mRNA-1010 12.5 ug | Number of Participants With Unsolicited AEs | All | 14 Participants |
| mRNA-1010 12.5 ug | Number of Participants With Unsolicited AEs | Serious | 0 Participants |
| mRNA-1010 25 ug | Number of Participants With Unsolicited AEs | Serious | 0 Participants |
| mRNA-1010 25 ug | Number of Participants With Unsolicited AEs | All | 47 Participants |
| mRNA-1010 25 ug | Number of Participants With Unsolicited AEs | Nonserious | 47 Participants |
| mRNA-1010 50 ug | Number of Participants With Unsolicited AEs | Serious | 1 Participants |
| mRNA-1010 50 ug | Number of Participants With Unsolicited AEs | All | 42 Participants |
| mRNA-1010 50 ug | Number of Participants With Unsolicited AEs | Nonserious | 41 Participants |
| mRNA-1010 100 ug | Number of Participants With Unsolicited AEs | Nonserious | 44 Participants |
| mRNA-1010 100 ug | Number of Participants With Unsolicited AEs | All | 46 Participants |
| mRNA-1010 100 ug | Number of Participants With Unsolicited AEs | Serious | 2 Participants |
| mRNA-1010 200 ug | Number of Participants With Unsolicited AEs | Serious | 0 Participants |
| mRNA-1010 200 ug | Number of Participants With Unsolicited AEs | Nonserious | 10 Participants |
| mRNA-1010 200 ug | Number of Participants With Unsolicited AEs | All | 10 Participants |
| mRNA-1010 >= 50 ug Overall | Number of Participants With Unsolicited AEs | Serious | 3 Participants |
| mRNA-1010 >= 50 ug Overall | Number of Participants With Unsolicited AEs | Nonserious | 95 Participants |
| mRNA-1010 >= 50 ug Overall | Number of Participants With Unsolicited AEs | All | 98 Participants |
Primary
Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
Time frame: Day 1 (Baseline), Day 29
Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 1.08 ratio |
| Placebo | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 1.05 ratio |
| Placebo | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 0.98 ratio |
| Placebo | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 0.92 ratio |
| Afluria Quadrivalent 60 ug | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 7.16 ratio |
| Afluria Quadrivalent 60 ug | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 1.95 ratio |
| Afluria Quadrivalent 60 ug | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 3.04 ratio |
| Afluria Quadrivalent 60 ug | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 7.50 ratio |
| mRNA-1010 6.25 ug | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 1.86 ratio |
| mRNA-1010 6.25 ug | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 6.43 ratio |
| mRNA-1010 6.25 ug | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 3.78 ratio |
| mRNA-1010 6.25 ug | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 8.69 ratio |
| mRNA-1010 12.5 ug | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 3.55 ratio |
| mRNA-1010 12.5 ug | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 7.13 ratio |
| mRNA-1010 12.5 ug | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 11.05 ratio |
| mRNA-1010 12.5 ug | Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 2.03 ratio |
Primary
Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Time frame: Day 29
Population: Per-Protocol (PP) Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 58.50 Titer |
| Placebo | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 56.49 Titer |
| Placebo | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 111.14 Titer |
| Placebo | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 103.94 Titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 376.02 Titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 237.44 Titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 379.02 Titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 410.71 Titer |
| mRNA-1010 6.25 ug | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 169.92 Titer |
| mRNA-1010 6.25 ug | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 325.07 Titer |
| mRNA-1010 6.25 ug | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 319.07 Titer |
| mRNA-1010 6.25 ug | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 331.06 Titer |
| mRNA-1010 12.5 ug | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 456.36 Titer |
| mRNA-1010 12.5 ug | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 537.26 Titer |
| mRNA-1010 12.5 ug | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 598.22 Titer |
| mRNA-1010 12.5 ug | Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 281.00 Titer |
Primary
Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if lower limit of quantification (LLOQ) was 1:10, a post-baseline titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was \>1:10, a post-baseline titer ≥4 x LLOQ if baseline was \<LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies.
Time frame: Day 29
Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 4.9 percentage of participants |
| Placebo | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 2.4 percentage of participants |
| Placebo | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 2.4 percentage of participants |
| Placebo | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 2.4 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 81.4 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 14.0 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 41.9 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 67.4 percentage of participants |
| mRNA-1010 6.25 ug | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 15.9 percentage of participants |
| mRNA-1010 6.25 ug | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 75.0 percentage of participants |
| mRNA-1010 6.25 ug | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 50.0 percentage of participants |
| mRNA-1010 6.25 ug | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 81.8 percentage of participants |
| mRNA-1010 12.5 ug | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 51.2 percentage of participants |
| mRNA-1010 12.5 ug | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 75.6 percentage of participants |
| mRNA-1010 12.5 ug | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 90.2 percentage of participants |
| mRNA-1010 12.5 ug | Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 25.0 percentage of participants |
Primary
Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Time frame: Day 29
Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 253.07 Titer |
| Placebo | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 114.21 Titer |
| Placebo | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 155.07 Titer |
| Placebo | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 193.16 Titer |
| Afluria Quadrivalent 60 ug | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 161.58 Titer |
| Afluria Quadrivalent 60 ug | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 55.76 Titer |
| Afluria Quadrivalent 60 ug | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 119.54 Titer |
| Afluria Quadrivalent 60 ug | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 228.02 Titer |
| mRNA-1010 6.25 ug | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 71.12 Titer |
| mRNA-1010 6.25 ug | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 216.32 Titer |
| mRNA-1010 6.25 ug | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 178.43 Titer |
| mRNA-1010 6.25 ug | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 316.53 Titer |
| mRNA-1010 12.5 ug | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 144.13 Titer |
| mRNA-1010 12.5 ug | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 301.53 Titer |
| mRNA-1010 12.5 ug | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 471.56 Titer |
| mRNA-1010 12.5 ug | Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 83.46 Titer |
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.95% CI: [0.57, 1.44]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.95% CI: [0.78, 2]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent. against H1N1 at Day 29.95% CI: [1.16, 2.99]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.95% CI: [0.91, 2.21]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.95% CI: [1.21, 2.97]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.95% CI: [1.68, 4.14]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.95% CI: [0.26, 0.5]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.95% CI: [0.33, 0.64]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.95% CI: [0.38, 0.76]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.95% CI: [0.43, 0.9]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.95% CI: [0.63, 1.35]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.95% CI: [0.51, 1.09]
Primary
Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if LLOQ was 1:10, a post-baseline titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was \>1:10, a post-baseline titer ≥4 x LLOQ if baseline was \<LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies. 95% CI was calculated using the Clopper-Pearson method
Time frame: Day 29
Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 47.9 percentage of participants |
| Placebo | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 47.9 percentage of participants |
| Placebo | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 50.0 percentage of participants |
| Placebo | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 43.8 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 44.9 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 59.2 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 10.2 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 24.5 percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 21.7 percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 43.5 percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 66.0 percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 68.1 percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 39.1 percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 73.9 percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 80.4 percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 28.3 percentage of participants |
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.95% CI: [-10.62, 28.31]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.95% CI: [-1.81, 36.61]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.95% CI: [4.2, 41.86]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.95% CI: [-18.41, 20.6]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.95% CI: [2.09, 40.6]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.95% CI: [17.38, 53.36]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.95% CI: [-53.36, -20.45]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.95% CI: [-43.66, -6.9]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.95% CI: [-37.95, 0.11]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.95% CI: [-41.09, -4.26]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of against Afluria Quadrivalent Yamagata-lineage at Day 29.95% CI: [-24.09, 15.59]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.95% CI: [-28.13, 11.27]
Primary
Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Time frame: Day 29
Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 164.00 titer |
| Placebo | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 85.54 titer |
| Placebo | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 147.47 titer |
| Placebo | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 193.08 titer |
| Afluria Quadrivalent 60 ug | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 153.43 titer |
| Afluria Quadrivalent 60 ug | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 100.51 titer |
| Afluria Quadrivalent 60 ug | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 215.19 titer |
| Afluria Quadrivalent 60 ug | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 298.88 titer |
| mRNA-1010 6.25 ug | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 129.56 titer |
| mRNA-1010 6.25 ug | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 187.08 titer |
| mRNA-1010 6.25 ug | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 230.66 titer |
| mRNA-1010 6.25 ug | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 422.24 titer |
| mRNA-1010 12.5 ug | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 231.44 titer |
| mRNA-1010 12.5 ug | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 215.23 titer |
| mRNA-1010 12.5 ug | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 443.62 titer |
| mRNA-1010 12.5 ug | Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 123.17 titer |
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.95% CI: [1.27, 2.61]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.95% CI: [1.79, 3.7]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.95% CI: [1.88, 3.88]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.95% CI: [1.29, 2.5]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.95% CI: [1.57, 3.05]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.95% CI: [1.81, 3.5]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.95% CI: [0.54, 0.87]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.95% CI: [0.69, 1.12]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.95% CI: [0.66, 1.06]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.95% CI: [0.86, 1.44]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.95% CI: [0.93, 1.54]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.95% CI: [0.93, 1.55]
Primary
Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if LLOQ was 1:10, a post-baseline titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was \>1:10, a post-baseline titer ≥4 x LLOQ if baseline was \<LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies. 95% CI was calculated using the Clopper-Pearson method
Time frame: Day 29
Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 59.6 percentage of participants |
| Placebo | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 40.4 percentage of participants |
| Placebo | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 32.7 percentage of participants |
| Placebo | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 32.7 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 66.0 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 22.9 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 41.7 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 72.2 percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 33.3 percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 71.7 percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 47.8 percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 84.8 percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 51.8 percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 78.7 percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 85.8 percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 37.1 percentage of participants |
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.95% CI: [12.33, 40.84]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.95% CI: [-2, 27.93]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.95% CI: [11.18, 39.89]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.95% CI: [9.82, 40.13]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.95% CI: [15.66, 45.73]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.95% CI: [22.98, 52.3]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.95% CI: [-24.83, 3.79]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.95% CI: [-14.91, 14.73]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.95% CI: [-11.19, 18.59]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.95% CI: [-6.72, 23.09]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.95% CI: [-0.74, 29.37]
Comparison: Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent. against Yamagata-lineage at Day 29.95% CI: [3.22, 33.22]
Secondary
Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the difference in the log-transformed values for GMT, then back transformed to the original scale for presentation.
Time frame: Day 1 (Baseline), Day 8 and Day 181
Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H1N1 | 0.78 ratio |
| Placebo | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H1N1 | 1.21 ratio |
| Placebo | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H3N2 | 0.96 ratio |
| Placebo | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H3N2 | 1.27 ratio |
| Placebo | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Victoria-lineage | 0.30 ratio |
| Placebo | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Victoria-lineage | 0.34 ratio |
| Placebo | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Yamagata-lineage | 0.48 ratio |
| Placebo | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Yamagata-lineage | 0.53 ratio |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Victoria-lineage | 0.54 ratio |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Victoria-lineage | 0.77 ratio |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H1N1 | 2.99 ratio |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Yamagata-lineage | 0.77 ratio |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Yamagata-lineage | 0.98 ratio |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H3N2 | 3.24 ratio |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H3N2 | 4.21 ratio |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H1N1 | 3.48 ratio |
| mRNA-1010 6.25 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Yamagata-lineage | 1.38 ratio |
| mRNA-1010 6.25 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H3N2 | 4.37 ratio |
| mRNA-1010 6.25 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H3N2 | 3.27 ratio |
| mRNA-1010 6.25 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Victoria-lineage | 1.24 ratio |
| mRNA-1010 6.25 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Victoria-lineage | 0.82 ratio |
| mRNA-1010 6.25 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Yamagata-lineage | 0.96 ratio |
| mRNA-1010 6.25 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H1N1 | 4.30 ratio |
| mRNA-1010 6.25 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H1N1 | 2.18 ratio |
| mRNA-1010 12.5 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H3N2 | 4.58 ratio |
| mRNA-1010 12.5 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H3N2 | 3.09 ratio |
| mRNA-1010 12.5 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H1N1 | 2.92 ratio |
| mRNA-1010 12.5 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H1N1 | 5.91 ratio |
| mRNA-1010 12.5 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Victoria-lineage | 0.85 ratio |
| mRNA-1010 12.5 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Yamagata-lineage | 0.85 ratio |
| mRNA-1010 12.5 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Yamagata-lineage | 1.51 ratio |
| mRNA-1010 12.5 ug | Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Victoria-lineage | 0.48 ratio |
Secondary
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Time frame: Day 1 (Baseline), Day 8 and Day 181
Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Yamagata-lineage | 54.68 titer |
| Placebo | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): H1N1 | 54.16 titer |
| Placebo | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Victoria-lineage | 37.59 titer |
| Placebo | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H1N1 | 42.05 titer |
| Placebo | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): Yamagata-lineage | 113.13 titer |
| Placebo | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): H3N2 | 53.68 titer |
| Placebo | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H3N2 | 51.46 titer |
| Placebo | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H1N1 | 67.55 titer |
| Placebo | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Yamagata-lineage | 55.08 titer |
| Placebo | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H3N2 | 67.50 titer |
| Placebo | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): Victoria-lineage | 113.97 titer |
| Placebo | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Victoria-lineage | 34.65 titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H1N1 | 167.28 titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Victoria-lineage | 91.27 titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H3N2 | 211.76 titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): Yamagata-lineage | 124.60 titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Yamagata-lineage | 118.85 titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Victoria-lineage | 76.56 titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H1N1 | 185.61 titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): Victoria-lineage | 121.61 titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H3N2 | 186.06 titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): H3N2 | 52.52 titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): H1N1 | 54.73 titer |
| Afluria Quadrivalent 60 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Yamagata-lineage | 106.23 titer |
| mRNA-1010 6.25 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Victoria-lineage | 72.27 titer |
| mRNA-1010 6.25 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H1N1 | 163.84 titer |
| mRNA-1010 6.25 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H1N1 | 74.14 titer |
| mRNA-1010 6.25 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): H3N2 | 50.59 titer |
| mRNA-1010 6.25 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H3N2 | 220.95 titer |
| mRNA-1010 6.25 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H3N2 | 158.74 titer |
| mRNA-1010 6.25 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): Victoria-lineage | 91.41 titer |
| mRNA-1010 6.25 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Victoria-lineage | 113.14 titer |
| mRNA-1010 6.25 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): Yamagata-lineage | 84.47 titer |
| mRNA-1010 6.25 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Yamagata-lineage | 116.79 titer |
| mRNA-1010 6.25 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Yamagata-lineage | 69.87 titer |
| mRNA-1010 6.25 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): H1N1 | 38.12 titer |
| mRNA-1010 12.5 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): Victoria-lineage | 137.99 titer |
| mRNA-1010 12.5 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H3N2 | 235.10 titer |
| mRNA-1010 12.5 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H1N1 | 319.86 titer |
| mRNA-1010 12.5 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Yamagata-lineage | 194.38 titer |
| mRNA-1010 12.5 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: H3N2 | 345.29 titer |
| mRNA-1010 12.5 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): H3N2 | 75.31 titer |
| mRNA-1010 12.5 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): H1N1 | 54.12 titer |
| mRNA-1010 12.5 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Yamagata-lineage | 112.06 titer |
| mRNA-1010 12.5 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: Victoria-lineage | 70.62 titer |
| mRNA-1010 12.5 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 8: Victoria-lineage | 122.10 titer |
| mRNA-1010 12.5 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 181: H1N1 | 159.95 titer |
| mRNA-1010 12.5 ug | Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Day 1 (Baseline): Yamagata-lineage | 128.43 titer |
Secondary
Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
Time frame: Day 29
Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 4.19 ratio |
| Placebo | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 3.17 ratio |
| Placebo | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 3.30 ratio |
| Placebo | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 3.07 ratio |
| Afluria Quadrivalent 60 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 3.33 ratio |
| Afluria Quadrivalent 60 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 6.28 ratio |
| Afluria Quadrivalent 60 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 7.64 ratio |
| Afluria Quadrivalent 60 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 2.27 ratio |
| mRNA-1010 6.25 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 12.15 ratio |
| mRNA-1010 6.25 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 3.73 ratio |
| mRNA-1010 6.25 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 8.17 ratio |
| mRNA-1010 6.25 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 3.06 ratio |
| mRNA-1010 12.5 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 11.96 ratio |
| mRNA-1010 12.5 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 8.70 ratio |
| mRNA-1010 12.5 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 2.79 ratio |
| mRNA-1010 12.5 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 3.67 ratio |
| mRNA-1010 25 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 3.72 ratio |
| mRNA-1010 25 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 3.91 ratio |
| mRNA-1010 25 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 3.78 ratio |
| mRNA-1010 25 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 6.08 ratio |
| mRNA-1010 50 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 2.29 ratio |
| mRNA-1010 50 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 1.69 ratio |
| mRNA-1010 50 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 4.51 ratio |
| mRNA-1010 50 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 6.03 ratio |
| mRNA-1010 100 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 3.03 ratio |
| mRNA-1010 100 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 7.21 ratio |
| mRNA-1010 100 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 1.84 ratio |
| mRNA-1010 100 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 6.66 ratio |
| mRNA-1010 200 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H3N2 | 9.30 ratio |
| mRNA-1010 200 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Victoria-lineage | 2.47 ratio |
| mRNA-1010 200 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | Yamagata-lineage | 3.08 ratio |
| mRNA-1010 200 ug | Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains | H1N1 | 12.58 ratio |
Secondary
Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29
Time frame: Day 29
Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H1N1 | 92.3 percentage of participants |
| Placebo | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H3N2 | 90.4 percentage of participants |
| Placebo | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Victoria-lineage | 96.2 percentage of participants |
| Placebo | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Yamagata-lineage | 96.2 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Yamagata-lineage | 99.3 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H3N2 | 91.0 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H1N1 | 97.2 percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Victoria-lineage | 91.7 percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H1N1 | 97.1 percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Yamagata-lineage | 96.4 percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H3N2 | 91.3 percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Victoria-lineage | 90.6 percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H1N1 | 98.6 percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H3N2 | 91.5 percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Victoria-lineage | 91.4 percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Yamagata-lineage | 97.2 percentage of participants |
| mRNA-1010 25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Yamagata-lineage | 97.9 percentage of participants |
| mRNA-1010 25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Victoria-lineage | 100.0 percentage of participants |
| mRNA-1010 25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H3N2 | 81.3 percentage of participants |
| mRNA-1010 25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H1N1 | 95.8 percentage of participants |
| mRNA-1010 50 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Yamagata-lineage | 93.9 percentage of participants |
| mRNA-1010 50 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Victoria-lineage | 75.5 percentage of participants |
| mRNA-1010 50 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H3N2 | 89.8 percentage of participants |
| mRNA-1010 50 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H1N1 | 93.9 percentage of participants |
| mRNA-1010 100 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Yamagata-lineage | 95.7 percentage of participants |
| mRNA-1010 100 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H1N1 | 95.7 percentage of participants |
| mRNA-1010 100 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Victoria-lineage | 89.1 percentage of participants |
| mRNA-1010 100 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H3N2 | 93.6 percentage of participants |
| mRNA-1010 200 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H3N2 | 97.8 percentage of participants |
| mRNA-1010 200 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Victoria-lineage | 82.6 percentage of participants |
| mRNA-1010 200 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | Yamagata-lineage | 91.3 percentage of participants |
| mRNA-1010 200 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29 | H1N1 | 97.8 percentage of participants |
Secondary
Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if lower limit of quantification (LLOQ) was 1:10, a post-baseline titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was \>1:10, a post-baseline titer ≥4 x LLOQ if baseline was \<LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies.
Time frame: Day 29
Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 59.6 Percentage of participants |
| Placebo | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 40.4 Percentage of participants |
| Placebo | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 32.7 Percentage of participants |
| Placebo | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 32.7 Percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 41.7 Percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 66.0 Percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 72.2 Percentage of participants |
| Afluria Quadrivalent 60 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 22.9 Percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 84.8 Percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 47.8 Percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 71.7 Percentage of participants |
| mRNA-1010 6.25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 33.3 Percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 85.8 Percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 78.7 Percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 37.1 Percentage of participants |
| mRNA-1010 12.5 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 51.8 Percentage of participants |
| mRNA-1010 25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 47.9 Percentage of participants |
| mRNA-1010 25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 47.9 Percentage of participants |
| mRNA-1010 25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 43.8 Percentage of participants |
| mRNA-1010 25 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 50.0 Percentage of participants |
| mRNA-1010 50 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 24.5 Percentage of participants |
| mRNA-1010 50 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 10.2 Percentage of participants |
| mRNA-1010 50 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 44.9 Percentage of participants |
| mRNA-1010 50 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 59.2 Percentage of participants |
| mRNA-1010 100 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 43.5 Percentage of participants |
| mRNA-1010 100 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 68.1 Percentage of participants |
| mRNA-1010 100 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 21.7 Percentage of participants |
| mRNA-1010 100 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 66.0 Percentage of participants |
| mRNA-1010 200 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H3N2 | 80.4 Percentage of participants |
| mRNA-1010 200 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Victoria-lineage | 28.3 Percentage of participants |
| mRNA-1010 200 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | Yamagata-lineage | 39.1 Percentage of participants |
| mRNA-1010 200 ug | Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B | H1N1 | 73.9 Percentage of participants |