A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

Respiratory Syncytial Virus Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743881
• Other study ID #: mRNA-1365-P101
• Secondary ID: 2022-502022-41
• Status: Recruiting
• Phase: Phase 1
• Start date: February 15, 2023
• Est. completion date: July 30, 2026

Study information

• Verified date: June 2024
• Source: ModernaTX, Inc.
• Contact: Moderna Clinical Trials Support Center
• Phone: 1-877-777-7187
• Email: clinicaltrials[@]modernatx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Months to 24 Months

Eligibility

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.

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.

Related Conditions & MeSH terms

• Human Metapneumovirus
• Respiratory Syncytial Virus

Intervention

Biological:
• mRNA-1345
Sterile liquid for injection
• mRNA-1365
Sterile liquid for injection
• Placebo
0.9% sodium chloride (normal saline) solution for injection

Drug:
• Nimenrix
Solution for injection

Locations

Country	Name	City	State
Australia	Monash Children's Hospital	Melbourne	Victoria
Australia	Telethon Kids Institute	Nedlands	Western Australia
Australia	Women's and Children's Hospital (WCH)	North Adelaide	South Australia
Australia	Queensland Children's Hospital	South Brisbane	Queensland
Canada	Dalhousie University IWK Health Centre	Halifax	Nova Scotia
Canada	London Health Sciences Centre - Victoria Hospital	London	Ontario
Canada	Universite de Montreal - Centre Hospitalier Universitaire (CHU) Sainte-Justine	Montreal	Quebec
Canada	BC Children's Hospital - Vaccine Evaluation Centre - Neonatology	Vancouver	British Columbia
Panama	CEVAXIN 24 de Diciembre	Ciudad de Panamá
Panama	CEVAXIN David	David	Chiriquí
Panama	CEVAXIN Chorrera	La Chorrera	Panama Oeste
Panama	CEVAXIN Avenida Mexico	Panama City
Poland	Centrum Badan Klinicznych JCI Jagiellonskie Centrum Innowacji Sp. z o.o.	Krakow	Malopolskie
Poland	Centrum Medyczne Plejady	Krakow
Poland	Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy	Trzebnica	Dolnoslaskie
Poland	Vistamed	Wroclaw	Dolnoslaskie
South Africa	Family Centre for Research with Ubuntu (FAMCRU)- Tygerberg	Cape Town	Western Cape
South Africa	Practice Dr Jan Vermeulen	Cape Town	Western Cape
South Africa	Shandukani Research CRS	Hillbrow	Gauteng
South Africa	Wits Health Consortium	Johannesburg	Gauteng
South Africa	Setshaba Research centre	Soshanguve	Gauteng
Spain	Hospital Universitario Arnau de Vilanova	Lleida
Spain	Hospital Carlos III-Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Complexo Hospitalario Universitario De Santiago	Santiago de Compostela	A Coruña
United Kingdom	Alder Hey NHS Foundation Trust - Pharmacy Clinical Trials	Liverpool
United Kingdom	Imperial College London and Imperial College Healthcare NHS	London
United Kingdom	St George's Hospital	London
United Kingdom	Norfolk and Norwich University Hospitals	Norwich
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Southampton General Hospital	Southampton
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke Vaccine and Trials Unit	Durham	North Carolina
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	Velocity Clinical Research, Denver	Englewood	Colorado
United States	Meridian Clinical Research	Hastings	Nebraska
United States	CyFair	Houston	Texas
United States	Mercury Clinical Research, Inc.	Houston	Texas
United States	Pediatric Associates	Houston	Texas
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	University Of Florida Health Science Center	Jacksonville	Florida
United States	MedPharmics - Platinum - PPDS	Lafayette	Louisiana
United States	Be Well Clinical Studies, LLC	Lincoln	Nebraska
United States	Los Angeles Children's Hospital	Los Angeles	California
United States	Matrix Clinical Research	Los Angeles	California
United States	Pediatric Specialty Care Discovery Clinic	Minneapolis	Minnesota
United States	Vanderbilt Vaccine Research Program	Nashville	Tennessee
United States	Palmetto Pediatrics, PA	North Charleston	South Carolina
United States	Accel Research Sites - Nona Pediatric Center	Orlando	Florida
United States	Village Pediatrics	Plano	Texas
United States	Velocity Clinical Research - Providence	Providence	Rhode Island
United States	Wake Research	Raleigh	North Carolina
United States	Mercury Clinical Research, Inc.	Richmond	Texas
United States	Pediatric Center	Richmond	Texas
United States	Washington University School of Medicine in St. Louis	Saint Louis	Missouri
United States	Childrens Hospital Regional Medical Center	Seattle	Washington
United States	Senders Pediatrics	South Euclid	Ohio
United States	Great Lakes Research Institute	Southfield	Michigan
United States	MultiCare Rockwood Main Clinic	Spokane	Washington
United States	North Houston Internal Medicine & Pediatric Clinic	Tomball	Texas
United States	Meridian Clinical Research	Washington	District of Columbia
United States	Meridian Clinical Research	Washington	District of Columbia
United States	UMASS Chan Medical School	Worcester	Massachusetts
United States	Umass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Panama,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)		Up to Day 120 (7 days after each injection)
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 141 (28 days after each injection)
Primary	Number of Participants with Medically-Attended Adverse Events (MAAEs)		Day 1 through Day 730
Primary	Number of Participants with Adverse Event of Special Interests (AESIs), Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation		Day 1 through Day 730
Secondary	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		Day 1 through Day 730
Secondary	Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies		Baseline up to Month 12
Secondary	GeometricMean Concentration (GMC) of Serum RSV F- and hMPV F-Binding Antibodies		Baseline up to Month 12
Secondary	Geometric Mean Fold-Rise (GMFR) Postbaseline/baseline Neutralizing Antibody Titers		Baseline up to Month 12