A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
- Conditions
- Respiratory Syncytial Virus
- Interventions
- Biological: PlaceboBiological: mRNA-1345Biological: Fluzone HD
- Registration Number
- NCT06060457
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in adults ≥65 years of age. The study will examine the impact of Fluzone HD on the immune response to mRNA-1345 against RSV-A and RSV-B, as well as the impact of mRNA-1345 on the immune response to Fluzone HD against 4 vaccine-matched Influenza A and B strains.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1900
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Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by:
- Absence of changes in medical therapy within 60 days of Day 1 due to treatment failure or toxicity,
- Absence of serious or significant medical events within 30 days of Day 1, and
- Absence of known, current, and life-limiting diagnoses which, in the opinion of the Investigator, would make completion of the protocol unlikely.
-
A participant assigned female at birth is eligible to participate if they are postmenopausal or not a person of childbearing potential.
Key
- Close contact with someone with laboratory-confirmed influenza and/or RSV infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1.
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
- Participant has tested positive for influenza or RSV by local health authority-approved testing methods ≤6 months prior to Day 1.
- Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections (Day 1 and Day 22) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study injections.
- Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤6 months prior to Day 1.
- Participant has received any RSV vaccine (authorized/approved by local health agency or investigational) prior to Day 1.
Note: Other protocol-defined inclusion and/or exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Fluzone HD + mRNA-1345 mRNA-1345 Participants will receive Fluzone HD + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22. Fluzone HD Followed by mRNA-1345 Placebo Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22. Fluzone HD + mRNA-1345 Placebo Participants will receive Fluzone HD + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22. Fluzone HD Followed by mRNA-1345 mRNA-1345 Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22. Fluzone HD + mRNA-1345 Fluzone HD Participants will receive Fluzone HD + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22. Fluzone HD Followed by mRNA-1345 Fluzone HD Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
- Primary Outcome Measures
Name Time Method Number of Participants With Medically Attended AEs (MAAEs) Day 1 through end of study (EOS; Day 202) Number of Participants with Unsolicited Adverse Events (AEs) 21 days after each injection Number of Participants With AEs Leading to Discontinuation Day 1 through EOS (Day 202) Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) 7 days after each injection Number of Participants With Adverse Events of Special Interest (AESIs) Day 1 through EOS (Day 202) Number of Participants With Serious Adverse Events (SAEs) Day 1 through EOS (Day 202) Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies (Abs) Day 22 (for Arm 1) and Day 43 (for Arm 2) GMT of Serum Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza Day 22
- Secondary Outcome Measures
Name Time Method Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Serum RSV-A and RSV-B Neutralizing Abs Baseline to Day 22 (for Arm 1) or 43 (for Arm 2) Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2) Baseline to Day 22 (for Arm 1) or 43 (for Arm 2) Seroresponse is defined as postvaccination titers ≥4× lower limit of quantification (LLOQ) if baseline is \<LLOQ or a ≥4-fold increase from baseline if baseline is ≥LLOQ.
Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B Neutralizing Ab Titers at Day 22 (for Arm 1) or Day 43 (for Arm 2) Baseline to Day 22 (for Arm 1) or 43 (for Arm 2) Percentage of Participants with Seroconversion as Measured by HAI Assay Baseline to Day 22 Seroconversion is defined as postvaccination titer ≥1:40 if baseline is \<1:10 or a ≥4-fold rise in postvaccination HAI Ab titer if baseline is ≥1:10.
GMFR of Serum Ab Level, as Measured by HAI Assay Baseline to Day 22
Trial Locations
- Locations (34)
Scottsdale Clinical Trials
🇺🇸Scottsdale, Arizona, United States
Headlands Research, Inc.
🇺🇸Scottsdale, Arizona, United States
West Coast Research LLC
🇺🇸Dublin, California, United States
Artemis Institute for Clinical Research
🇺🇸Riverside, California, United States
Peninsula Research Associates (PRA)
🇺🇸Rolling Hills Estates, California, United States
Acclaim Clinical Research
🇺🇸San Diego, California, United States
Neoclinical Research
🇺🇸Hialeah, Florida, United States
Health Awareness INC
🇺🇸Jupiter, Florida, United States
South Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
Suncoast Research Associates, LLC
🇺🇸Miami, Florida, United States
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