CompletedPhase 1

A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive

United States651 participantsStarted 2020-09-30

Plain-language summary

The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.

Who can participate

Age range

12 Months – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Healthy young adults ≥18 to ≤49 years of age, women of child-bearing potential ≥18 to ≤40 years of age, healthy older adults ≥65 to \<80 years of age, Japanese older adults ≥ 60 years of age, and children ≥12 to \< 60 months of age. * Willing and physically able to comply with protocol-mandated follow-up, including all procedures. * Adult participant or parent(s)/legal guardian(s) of pediatric participants has provided written informed consent for participation in this study, including all evaluations and procedures as specified by the protocol. Specific inclusion criteria for adults (younger adults, women of child-bearing potential, and older adults \[including Japanese older adults\]): * Has a body mass index (BMI) from ≥18 kilogram (kg)/meter (m)\^2 to ≤35 kg/m\^2. * Female participants of non-child-bearing potential. This criterion does not apply for women of child-bearing potential Cohorts 12, 13, and 14. * Female participants of child-bearing potential may be enrolled in the study, if the participant: 1) has a negative urine pregnancy test at Screening and on the day of vaccination; 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination; 3) has agreed to continue adequate contraception through 3 months following the last injection; and 4) is not currently breastfeeding. Specific inclusion criteria for children 12 to 59 months of age: * Seropositive for RSV-…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

Timeframe: Up to Day 737 (7 days after each injection)

Number of Participants with Unsolicited Adverse Events (AEs)

Timeframe: Up to Day 758 (28 days after the last injection)

Number of Participants with Serious AEs or Medically Attended AEs (MAAEs)

Timeframe: Up to Day 1095 (End of Study)

Trial details

NCT IDNCT04528719

SponsorModernaTX, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-18

View on ClinicalTrials.gov More Respiratory Syncytial Virus trials