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Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05572658
Recruitment Status : Recruiting
First Posted : October 10, 2022
Last Update Posted : January 11, 2023
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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Brief Summary:
The main goal of this observational study is to evaluate the real-world effectiveness of the Moderna mRNA-1345 vaccine for protection against RSV lower respiratory tract disease (RSV-LRTD) and to study additional health and economic outcomes.

Condition or disease Intervention/treatment
Respiratory Syncytial Virus Biological: mRNA-1345 Biological: Placebo

Detailed Description:
This study will evaluate real-world data (RWD) and data from eligible United States (US) based participants from Study mRNA-1345-P301 (NCT05127434) for the short- and long-term effectiveness of the mRNA-1345 vaccine in preventing RSV-associated health outcomes such as hospitalizations, death, healthcare resource utilization, and costs. The results from the current study (mRNA-1345-P901) are intended to complement the results from the mRNA-1345-P301 study. No interventions will be administered during the current study (mRNA-1345-P901).
Study Design
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Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: mRNA-1345-P901 Study: RSV Outcomes Study Extension (ROSE)
Actual Study Start Date : September 15, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2026
Groups and Cohorts
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Group/Cohort Intervention/treatment
mRNA-1345: Exposed
Eligible US participants from the mRNA-1345-P301 (P301) study who received the mRNA-1345 vaccine.
 Biological: mRNA-1345
Sterile liquid for injection
Placebo/Control: Referent
Eligible US participants from the P301 study who received placebo and eligible US-based, matched, unvaccinated RWD participants.
 Biological: Placebo
0.9% sodium chloride (normal saline) injection


Outcome Measures
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Primary Outcome Measures :
  1. Incidence Rate of Hospitalizations for All-cause, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV [ Time Frame: From Day 15 up to 1, 2, or 3 years ]

Secondary Outcome Measures :
  1. Death Rate Within 30 Days, 31-365 Days, and up to 3 Years After mRNA-1345 Exposure [ Time Frame: From Day 15 to Day 30, 31-365, and up to 3 years ]
  2. Incidence Rate of Discharge to Long-term or Short-term Institutional Care Following Hospitalization for All-cause, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV [ Time Frame: From Day 15 up to 1, 2, or 3 years ]
  3. Length of Stay of Hospitalizations for All-cause, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, Or RSV [ Time Frame: From Day 15 up to 3 years ]
  4. Length of Stay of Hospitalizations Related to All-Causes, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV [ Time Frame: Up to 1 year ]
  5. Mean Total Cost of Hospitalizations Related to All-Causes, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV [ Time Frame: Up to 1 Year ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The population of interest will include P301 participants randomized in the US who provide informed consent and meet eligibility criteria and the RWD-matched unvaccinated population.
Criteria

Inclusion Criteria:

P901 inclusion criteria:

  • RWD-matched unvaccinated
  • Must be a participant in P301
  • Must be based in the US
  • Must provide informed consent for P901

P301 key inclusion criteria:

  • Adults who are primarily responsible for self-care and activities of daily living.
  • Participants may have one or more chronic medical diagnoses (specifically chronic heart failure and chronic obstructive pulmonary disease) but should be medically stable in the opinion of the investigator.
  • Body mass index from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2.

Exclusion Criteria:

P901 exclusion criteria:

  • Receipt of any future licensed RSV vaccine at baseline.
  • Receipt of any future licensed RSV vaccines during the study follow-up period will result in censorship on the date the vaccine was received.

All inclusion and exclusion criteria from P301 that are available in the RWD will be applied to the enriched RWD control population.

P301 key exclusion criteria:

  • Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 45 days before the planned date of the Day 1 vaccination.
  • Prior participation in research involving receipt of any investigational RSV product (drug/biologic/device).
  • History of a serious reaction to any prior vaccination or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
  • Received or plans to receive any non-study vaccine within 28 days before or after the Day 1 study injection. The exceptions are seasonal influenza vaccines, pneumococcal vaccines, or authorized or approved vaccines for the prevention of COVID-19 (regardless of type of vaccine), which are not permitted within 14 days before or after the Day 1 study injection. Efforts should be made to space study injection and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.

Other inclusion and/or exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05572658


Contacts
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Contact: Moderna Clinical Trials Support Center 1-877-777-7187 clinicaltrials@modernatx.com

Locations
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Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05572658    
Other Study ID Numbers: mRNA-1345-P901
First Posted: October 10, 2022    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 2023
Keywords provided by ModernaTX, Inc.:
Viral Diseases
Messenger RNA
Moderna
 mRNA-1345
Effectiveness
Vaccines