A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 75 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

15 sites in 1 country.

About this study

Official title: Phase 1/2, Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1020 and mRNA-1030 Candidate Seasonal Influenza Vaccines in Healthy Adults

Conditions

Seasonal Influenza

Being tested

mRNA-1030, mRNA-1020, mRNA-1010, Active Comparator

Keywords

Influenza vaccine, mRNA-1020, mRNA-1030, Moderna

Medical subject headings

Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• mRNA-1030Biological

  Also called Seasonal influenza vaccine

  Sterile liquid for injection

• mRNA-1020Biological

  Also called Seasonal influenza vaccine

  Sterile liquid for injection

• mRNA-1010Biological

  Also called Seasonal influenza vaccine

  Sterile liquid for injection

• Active ComparatorBiological

  Also called Seasonal influenza vaccine

  Sterile liquid for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Number of Participants With Solicited Local and Systemic Adverse Reactions (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. 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. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section and presented by each dose group separately.

   Measured: Up to Day 7 (7 days after vaccination)

2. Number of Participants With Unsolicited Adverse Events (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 dose group separately.

   Measured: Up to Day 28 (28 days after vaccination)

3. Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs)

   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 dose group separately.

   Measured: Day 1 through Day 181

4. Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains

   Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.

   Measured: Day 29

5. GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) 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.

   Measured: Day 29

6. Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay 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. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.

   Measured: Day 29

7. GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI 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. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.

   Measured: Day 29

8. Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B

   Seroconversion at a participant level is defined as corresponding visit titer ≥ 4*LLOQ (lower limit of quantification) if baseline is < LLOQ or a 4-fold or greater rise if baseline is ≥ LLOQ in anti-HA antibodies. When LLOQ is 1:10, seroconversion is defined as a corresponding visit titer ≥ 1:40 if baseline is < 1:10 or a 4-fold or greater rise if baseline is ≥ 1:10 in anti- HA antibodies measured by HAI assay. 95% CI was calculated using the Clopper-Pearson method.

   Measured: Day 29

9. Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay

   ≥ z-fold rise from baseline at participant level is defined as a ≥ z x LLOQ for participants with baseline antibody level < LLOQ, or a z-times or higher antibody level ratio in participants with baseline antibody level ≥ LLOQ. 95% CI was calculated using the Clopper-Pearson method.

   Measured: Baseline (Day 1), Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted18 Apr 2022
2. Study start6 Apr 2022
3. Primary completion22 Nov 2022
4. Study completion22 Nov 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Seasonal InfluenzaStudies of the same condition, open and under way.
• More trials run by ModernaTX, Inc.The sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.