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Phase 2 Completed N=885 Randomized Quadruple-blind Prevention

A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults

Source: ClinicalTrials.gov NCT04956575 ↗
Enrolled (actual)
885
Serious AEs
2.2%
Results posted
Oct 2023
Primary outcomePrimary: Number of Participants With Solicited Local and Systemic ARs — 12; 43; 22; 16 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Solicited Local and Systemic ARs
12; 43; 22; 16; 76; 65
PRIMARY
Number of Participants With Unsolicited AEs
6; 20; 17; 14; 47; 42
PRIMARY
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs)
2; 2; 2; 0; 3; 5
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
58.50; 410.71; 331.06; 598.22; 56.49; 376.02
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
164.00; 298.88; 422.24; 443.62; 85.54; 153.43
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
253.07; 228.02; 316.53; 471.56; 114.21; 161.58
PRIMARY
Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
4.9; 67.4; 81.8; 90.2; 2.4; 81.4
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
1.08; 7.50; 8.69; 11.05; 1.05; 7.16
PRIMARY
Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
59.6; 72.2; 84.8; 85.8; 40.4; 66.0
PRIMARY
Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
50.0; 59.2; 68.1; 73.9; 43.8; 44.9
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
54.16; 54.73; 38.12; 54.12; 42.05; 185.61
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
0.78; 3.48; 4.30; 5.91; 1.21; 2.99
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
59.6; 72.2; 84.8; 85.8; 50.0; 59.2
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
4.19; 7.64; 12.15; 11.96; 6.08; 6.03
SECONDARY
Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29
92.3; 97.2; 97.1; 98.6; 95.8; 93.9

Eligibility 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 as
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04956575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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