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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
2/12/2024

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
Parts A and B: 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
Part C: GMT of Serum RSV Neutralizing Antibodies
Timepoint [3] 0 0
Baseline up to Month 12
Secondary outcome [4] 0 0
Parts A and B: Geometric Mean Concentration (GMC) of Serum RSV F- and hMPV F-Binding Antibodies
Timepoint [4] 0 0
Baseline up to Month 12
Secondary outcome [5] 0 0
Part C: GMC of Serum RSV F-Binding Antibodies
Timepoint [5] 0 0
Baseline up to Month 12
Secondary outcome [6] 0 0
Geometric Mean Fold-Rise (GMFR) Postbaseline/baseline Neutralizing Antibody Titers
Timepoint [6] 0 0
Baseline up to Month 12
Secondary outcome [7] 0 0
Number of Participants with Vaccine-specific T-cell Responses Measured by Flow Cytometry
Timepoint [7] 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 at any time since birth, 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 (Part A: within 3 months; Part B and Part C: since birth) or hMPV infection (Part A: within 3 months; Part B: 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 (Parts A, B, and C) or hMPV infection (Parts A or B) within 14 days prior to administration of the first dose of IP.
* 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 (Parts A, B, and C) or hMPV (Parts A and B) infection or if the participant's mother received an investigational or approved vaccine for the prevention of RSV (Parts A, B, and C) or hMPV (Parts A and B) 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
30/09/2026
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
Trial website
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
clinicaltrials@modernatx.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05743881