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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05743881




Registration number
NCT05743881
Ethics application status
Date submitted
15/02/2023
Date registered
24/02/2023
Date last updated
9/08/2024

Titles & IDs
Public title
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
Scientific title
A Phase 1, Randomized, Observer-blind, Placebo-controlled, Age De-escalation Study of the Safety, Tolerability, and Immunogenicity of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
Secondary ID [1] 0 0
2022-502022-41
Secondary ID [2] 0 0
mRNA-1365-P101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - mRNA-1345
Treatment: Other - mRNA-1365
Treatment: Other - Placebo
Treatment: Drugs - Nimenrix

Experimental: Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months) - Participants will receive mRNA-1345 vaccine by intramuscular (IM) injection on Days 1, 57 and 113.

Experimental: Part A: mRNA-1365, Dose 1 (Age Group: 8 to <24 months) - Participants will receive mRNA-1365 vaccine by IM injection on Days 1, 57 and 113.

Placebo comparator: Part A: Placebo (Age Group: 8 to <24 months) - Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113.

Experimental: Part B: mRNA-1345, Dose 2 (Age Group: 5 to <8 months) - Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113.

Experimental: Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months) - Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113.

Experimental: Part B: mRNA-1345 Dose 1 (Age Group: 5 to <8 months) - Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113.

Experimental: Part B: mRNA-1365 Dose 1 (Age Group: 5 to <8 months) - Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113.

Placebo comparator: Part B: Placebo (Age Group: 5 to <8 months) - Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113.

Experimental: Part C: mRNA-1345 Dose 1 (Age Group 8 to <12 months exposed to nirsevimab) - Participants who have been previously exposed to nirsevimab will receive mRNA 1345 by IM on Days 1, 57, and 113.

Experimental: Part C: mRNA-1345 Dose 1 (Age Group 8 to <12 months not exposed to nirsevimab) - Participants who have not been previously exposed to nirsevimab will receive mRNA 1345 by IM on Days 1, 57, and 113.


Treatment: Other: mRNA-1345
Sterile liquid for injection

Treatment: Other: mRNA-1365
Sterile liquid for injection

Treatment: Other: Placebo
0.9% sodium chloride (normal saline) solution for injection

Treatment: Drugs: Nimenrix
Solution for injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 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 Day 120 (7 days after each injection)
Primary outcome [2] 0 0
Number of Participants with Unsolicited Adverse Events (AEs)
Timepoint [2] 0 0
Up to Day 141 (28 days after each injection)
Primary outcome [3] 0 0
Number of Participants with Medically-Attended Adverse Events (MAAEs)
Timepoint [3] 0 0
Day 1 through Day 730
Primary outcome [4] 0 0
Number of Participants with Adverse Event of Special Interests (AESIs), Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation
Timepoint [4] 0 0
Day 1 through Day 730
Secondary outcome [1] 0 0
Number of Participants with Respiratory Tract Illness (RTI), Lower Respiratory Tract Illness (LRTI), Severe LRTI, Very Severe LRTI, and Hospitalizations Associated with RSV or hMPV
Timepoint [1] 0 0
Day 1 through Day 730
Secondary outcome [2] 0 0
Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies
Timepoint [2] 0 0
Baseline up to Month 12
Secondary outcome [3] 0 0
GeometricMean Concentration (GMC) of Serum RSV F- and hMPV F-Binding Antibodies
Timepoint [3] 0 0
Baseline up to Month 12
Secondary outcome [4] 0 0
Geometric Mean Fold-Rise (GMFR) Postbaseline/baseline Neutralizing Antibody Titers
Timepoint [4] 0 0
Baseline up to Month 12

Eligibility
Key inclusion criteria
* The participant is 8 months to <24 months (Part A), 5 months to <8 months (Part B), or 8 months to <12 months (Part C) of age at the time of randomization (Day 1/Baseline visit), who is in good general health, in the opinion of the Investigator, based on review of medical history and screening physical examination.
* In the Investigator's opinion, the parent(s)/ legally authorized representative (LAR)(s) understand and are willing and physically able to comply with protocol-mandated follow up, including all procedures, and provide written informed consent.
* The participant is growing normally for age in the opinion of the site clinician in the months prior to enrollment.
* The participant was born at full-term (=37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg).
* For Part C Cohort 7: participant must have received nirsevimab =6 months prior to Day 1 Visit.
* For Part C Cohort 8: participant was eligible, according to national guidelines, to receive nirsevimab prior to Day 1 Visit but did not do so.
Minimum age
5 Months
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a known history of symptomatic RSV or hMPV infection (Part A: within 3 months; Part B: and Part C since birth) prior to administration of the first dose of investigational product (IP) or has a known close contact with anyone with laboratory-confirmed RSV or hMPV infection within 14 days prior to administration of the first dose of IP (Part A, B, and C).
* Is acutely ill or febrile 24 hours prior to or at the screening visit. Fever is defined as a body temperature =38.0°Celsius/=100.4°Fahrenheit. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows.
* Has previously been administered an investigational or approved vaccine for prevention of RSV or hMPV infection or if the participant's mother received an investigational or approved vaccine for the prevention of RSV or hMPV infection during pregnancy.
* Has received investigational or approved agents for prophylaxis against RSV or hMPV (for example, monoclonal antibodies) or is intending to receive these during the course of the study. For Part C (Cohort 7 only), use of nirsevimab =6 months before Day 1 Visit is allowed.
* Has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to a previous dose of an mRNA vaccine or any of its components (including polyethylene glycol or immediate allergic reaction of any severity to polysorbate).
* Has a medical condition that, according to the Investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Study design
Purpose of the study
Treatment
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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
15/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/07/2026
Actual
Sample size
Target
310
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Telethon Kids Institute - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Nova Scotia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Panama
State/province [23] 0 0
Chiriquí
Country [24] 0 0
Panama
State/province [24] 0 0
Panama Oeste
Country [25] 0 0
Panama
State/province [25] 0 0
Ciudad de Panamá
Country [26] 0 0
Panama
State/province [26] 0 0
Panama City
Country [27] 0 0
Poland
State/province [27] 0 0
Dolnoslaskie
Country [28] 0 0
Poland
State/province [28] 0 0
Malopolskie
Country [29] 0 0
Poland
State/province [29] 0 0
Krakow
Country [30] 0 0
South Africa
State/province [30] 0 0
Gauteng
Country [31] 0 0
South Africa
State/province [31] 0 0
Western Cape
Country [32] 0 0
Spain
State/province [32] 0 0
A Coruña
Country [33] 0 0
Spain
State/province [33] 0 0
Lleida
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Liverpool
Country [36] 0 0
United Kingdom
State/province [36] 0 0
London
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Norwich
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Oxford
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to \<24 months.
Trial website
https://clinicaltrials.gov/study/NCT05743881
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
Moderna Clinical Trials Support Center
Address 0 0
Country 0 0
Phone 0 0
1-877-777-7187
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05743881