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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05127434




Registration number
NCT05127434
Ethics application status
Date submitted
9/11/2021
Date registered
19/11/2021
Date last updated
31/05/2024

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults =60 Years of Age
Scientific title
A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults =60 Years of Age
Secondary ID [1] 0 0
mRNA-1345-P301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - mRNA-1345

Experimental: mRNA-1345 - Single injection of mRNA-1345 on Day 1.

Experimental: Placebo - Single injection of mRNA-1345 matching-placebo on Day 1.

Experimental: mRNA-1345 BD - Single injection of mRNA-1345 on BD Day 1.


Treatment: Drugs: Placebo
0.9% sodium chloride (normal saline) injection

Treatment: Drugs: mRNA-1345
Sterile liquid for injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Timepoint [1] 0 0
Up to 7 days after each injection
Primary outcome [2] 0 0
Number of Participants with Unsolicited Adverse Events (AEs)
Timepoint [2] 0 0
Up to 28 days after each injection
Primary outcome [3] 0 0
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Withdrawal
Timepoint [3] 0 0
Up to BD Day 181
Primary outcome [4] 0 0
Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms
Timepoint [4] 0 0
From 14 days postinjection up to 12 months postinjection
Primary outcome [5] 0 0
VE of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 3 or More Symptoms
Timepoint [5] 0 0
From 14 days postinjection up to 12 months postinjection
Primary outcome [6] 0 0
Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies
Timepoint [6] 0 0
BD Day 29
Primary outcome [7] 0 0
Geometric Mean Ratio (GMR) of Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose
Timepoint [7] 0 0
BD Day 29
Secondary outcome [1] 0 0
VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD)
Timepoint [1] 0 0
From 14 days postinjection up to 12 months postinjection
Secondary outcome [2] 0 0
VE of mRNA-1345 to Prevent First Hospitalization Associated with RSV-ARD or RSV-LRTD
Timepoint [2] 0 0
From 14 days postinjection up to 12 months postinjection
Secondary outcome [3] 0 0
GMT of Serum RSV Neutralizing Antibodies
Timepoint [3] 0 0
Baseline through up to 24 months postinjection
Secondary outcome [4] 0 0
Geometric Mean Concentration (GMC) of Serum RSV Binding Antibodies
Timepoint [4] 0 0
Baseline through up to 24 months postinjection
Secondary outcome [5] 0 0
Seroresponse Rate in RSV Neutralizing Antibodies
Timepoint [5] 0 0
Baseline through up to 24 months postinjection
Secondary outcome [6] 0 0
Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Antibody Titers
Timepoint [6] 0 0
Baseline through up to 24 months postinjection
Secondary outcome [7] 0 0
Proportion of Participants with =4-fold Increases in Antibody Titers from Baseline
Timepoint [7] 0 0
Baseline through up to 24 months postinjection
Secondary outcome [8] 0 0
Seroresponse Rate (SRR) Difference Between Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose
Timepoint [8] 0 0
BD Day 29
Secondary outcome [9] 0 0
GMT of Serum RSV-A and RSV-B Neutralizing Antibodies
Timepoint [9] 0 0
BD Day 1 and Day 181
Secondary outcome [10] 0 0
GMFR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline)
Timepoint [10] 0 0
Baseline, BD Day 1, Day 29 and Day 181
Secondary outcome [11] 0 0
SRR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline)
Timepoint [11] 0 0
Baseline, BD Day 1, Day 29 and Day 181

Eligibility
Key inclusion criteria
Key Inclusion Criteria (Part A):

* Adults = 60 years of age who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses (including chronic heart failure [CHF] and chronic obstructive pulmonary disease [COPD]), but should be medically stable
* Body mass index from =18 kilograms (kg)/square meter (m^2) to =35 kg/m^2

Key Inclusion Criteria (Part B):

* Randomized to and were subsequently vaccinated with the mRNA-1345 study injection in Part A at least 21 months prior to Screening.

Key
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria (Part A):

* Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of the Day 1 study injection.
* Current participation in research involving receipt of any investigational RSV product
* 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.

Key Exclusion Criteria (Part B):

* Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of BD study injection (BD Day 1).
* 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 (including authorized or approved vaccines for the prevention of coronavirus disease 2019 (COVID-19) regardless of type of vaccine) within 14 days before or after the BD Day 1 study injection.
* Received or plans to receive any commercial RSV vaccination at any time prior to BD study injection (BD Day 1) or during the substudy.

Other inclusion and/or exclusion criteria may apply.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/08/2025
Actual
Sample size
Target
Accrual to date
Final
36814
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research - Canberra - PPDS - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research - Western Sydney - PPDS - Blacktown
Recruitment hospital [3] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [4] 0 0
Northside Health - Coffs Harbour
Recruitment hospital [5] 0 0
Holdsworth House Medical Brisbane - Fortitude Valley
Recruitment hospital [6] 0 0
Emeritus Research - PPDS - Camberwell
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2100 - Brookvale
Recruitment postcode(s) [4] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [5] 0 0
4006 - Fortitude Valley
Recruitment postcode(s) [6] 0 0
3124 - Camberwell
Recruitment outside Australia
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Ponce
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South Africa
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Gauteng
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Kwazulu - Natal
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Spain
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Barcelona
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Madrid
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Valencia
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Taiwan
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Taichung City
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Taichung
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Taipei City
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Taiwan
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Taoyuan City
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United Kingdom
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Avon
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Lancashire
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Northumberland
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Staffordshire
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Tyne And Wear
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Bellshill
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Birmingham
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Blackpool
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Cardiff
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Liverpool
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ModernaTX, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months.

The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.
Trial website
https://clinicaltrials.gov/study/NCT05127434
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05127434