COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05330975

Not reported

Not reported

2022-04-15

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

key inclusion criteria: parts a and b both: adults ≥50 years of age on the day of the randomization visit (day 1) who are primarily responsible for self-care and activities of daily living. participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by: absence of changes in medical therapy within 1 month due to treatment failure or toxicity; absence of medical events qualifying as saes within 1 month of the planned vaccination on 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. able to comply with study requirements, including access to transportation for study visits. part b only: fully vaccinated for covid-19 with an approved primary series according to the locally authorized or approved regimen. if the most recent covid-19 vaccine was part of a primary series, it must be ≥ 150 days before (or less per local guidance) day 1. if the most recent covid-19 vaccine was a booster dose, it must be ≥ 120 days before (or less per local guidance) day 1. key

part a: 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) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections. prior participation in research involving receipt of any investigational product (drug/biologic/device including any investigational rsv product) within 45 days before the planned date of the day 1 study injection. participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤180 days prior to the randomization visit (day 1). history of a serious reaction to any prior vaccination, or guillain-barré syndrome within 6 weeks of any prior influenza immunization. participated in an interventional clinical study within 28 days prior to the screening visit based on the medical history interview or plans to do so while participating in this study. part b: 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) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections (with the exception of sars-cov-2 vaccination). prior participation in research involving receipt of any investigational product (drug/biologic/device with the exception of rsv investigation products) within 45 days before the planned date of the day 1 study injection. prior receipt of any investigational/approved rsv product within 1 year of the day 1 study injection. has known history of sars-cov-2 infection within 90 days prior to enrollment. parts a and b both: participant had significant exposure to someone with sars-cov-2 infection or covid-19 in the past 10 days, as defined by the united states (us) centers for disease control and prevention (cdc) as a close contact of someone who has had covid-19. other inclusion and/or exclusion criteria may apply.

6

ModernaTX, Inc.

50

100

United States

Healthy volunteers

N/A

3354

Geometric Mean Concentration (GMC) of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 29;Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29;GMT of Serum Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29;Number of Participants With Medically Attended AEs (MAAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Withdrawal;Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);Percentage of Participants With Seroresponse for SARS-Cov-2 Neutralizing Abs From Baseline to Day 29;Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to Day 29

None

Phase 3

[{"arm_notes": "nan", "treatment_id": 2588, "treatment_name": "Mrna-1345+quadrivalent inactivated influenza vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "nan", "treatment_id": 2589, "treatment_name": "Mrna-1345+placebo", "treatment_type": "Rna based vaccine+placebo", "pharmacological_treatment": "Vaccine+placebo"}, {"arm_notes": "nan", "treatment_id": 2590, "treatment_name": "Placebo+quadrivalent inactivated influenza vaccine", "treatment_type": "Placebo+non covid vaccine", "pharmacological_treatment": "Placebo+non covid vaccine"}, {"arm_notes": "nan", "treatment_id": 2589, "treatment_name": "Mrna-1345+placebo", "treatment_type": "Rna based vaccine+placebo", "pharmacological_treatment": "Vaccine+placebo"}, {"arm_notes": "nan", "treatment_id": 2591, "treatment_name": "Mrna-1273.214+mrna-1345", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2592, "treatment_name": "Mrna-1273.214+placebo", "treatment_type": "Rna based vaccine+placebo", "pharmacological_treatment": "Vaccine+placebo"}]