Seasonal Influenza
Conditions
Keywords
Flu, Influenza, Vaccine, mRNA vaccine, mRNA-1010, Moderna
Brief summary
The purpose of this study is to evaluate safety, reactogenicity, and immunogenicity of mRNA-1010 in healthy children (9 to \<18 years of age).
Interventions
BIOLOGICALmRNA-1010
Suspension for injection
BIOLOGICALFluarix Trivalent
Suspension for injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* 9 to \<18 years of age inclusive, at the time of signing the informed consent/assent. * In the Investigator's opinion, the participants/participant's parent(s)/legally authorized representative (LAR(s)) demonstrate adequate understanding of the study requirements and are willing and physically able to comply with protocol mandated follow-up, including all procedures. * 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, and agreement to continue adequate contraception through 90 days following vaccine administration.
Exclusion criteria
* History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic; influenza vaccine; or components of influenza vaccine, including egg protein. * Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) \[100.4 degrees Fahrenheit \[°F\]) within 72 hours prior to or at the Screening Visit or Day 1. Participants who are acutely ill or febrile may be scheduled for a separate dosing visit within the window specified for Screening. * History of a diagnosis or condition not specifically listed as exclusionary that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures. * Any prior systemic immunosuppressants, immunomodulators (for example, methotrexate, cyclosporine), or long-acting biological therapies that may affect immune responses (for example, dupilumab, omalizumab). Short courses (\<7 days) of oral corticosteroids are allowed if completed at least 3 months prior to Day 1. Inhaled, nasal, topical steroids, and subcutaneous injected allergy immunotherapy (allergy shots) are allowed. * Received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive them during the study. * Received any nonstudy vaccine authorized or approved by local health agency within 14 days (28 days for live vaccines and mRNA vaccines) prior to Day 1 (inclusive) or plans to receive any nonstudy vaccine within 28 days post study vaccine administration. * Donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days post study vaccine administration. Note: Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay | Day 29 | — |
| Percentage of Participants Reaching Seroconversion, as Measured by HAI Assay | Day 29 | Seroconversion is defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer. |
| Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 | Day 29 | — |
| Geometric Mean Fold Rise (GMFR) of Anti-HA antibodies, as Measured by HAI Assays | Day 29 | — |
| Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to Day 7 (7 days after vaccination) | — |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 28 (28 days after vaccination) | — |
| Number of Participants with AEs Leading to Discontinuation, Serious Adverse Events (SAEs), or Adverse Events of Special Interest (AESI) | Day 1 through Day 365 | — |
| Number of Participants with Medically Attended AEs (MAAEs) | Day 1 through Day 181 | — |
Countries
United States
Contacts
CONTACTModerna WeCare Team
Outcome results
None listed