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

Last updated: November 27, 2024
Sponsor: ModernaTX, Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Respiratory Syncytial Virus (Rsv)

Treatment

mRNA-1345

Nimenrix

mRNA-1365

Clinical Study ID

NCT05743881
mRNA-1365-P101
2022-502022-41
2022-502022-41-00
  • Ages 5-24
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theInvestigator, 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 withprotocol-mandated follow up, including all procedures, and provide written informedconsent.

  • The participant is growing normally for age in the opinion of the site clinician inthe months prior to enrollment.

  • The participant was born at full-term (≥37 weeks gestation) with a minimum birthweight of 2.5 kilograms (kg).

  • For Part C Cohort 7: participant must have received nirsevimab ≥6 months prior toDay 1 Visit.

  • For Part C Cohort 8: participant was eligible at any time since birth, according tonational guidelines, to receive nirsevimab prior to Day 1 Visit but did not do so.

Exclusion

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) priorto administration of the first dose of investigational product (IP) or has a knownclose contact with anyone with laboratory-confirmed RSV (Parts A, B, and C) or hMPVinfection (Parts A or B) within 14 days prior to administration of the first dose ofIP.

  • Is acutely ill or febrile 24 hours prior to or at the screening visit. Fever isdefined as a body temperature ≥38.0°Celsius/≥100.4°Fahrenheit. Participants who meetthis criterion may have visits rescheduled within the relevant study visit windows.

  • Has previously been administered an investigational or approved vaccine forprevention of RSV (Parts A, B, and C) or hMPV (Parts A and B) infection or if theparticipant's mother received an investigational or approved vaccine for theprevention of RSV (Parts A, B, and C) or hMPV (Parts A and B) infection duringpregnancy.

  • Has received investigational or approved agents for prophylaxis against RSV or hMPV (for example, monoclonal antibodies) or is intending to receive these during thecourse of the study. For Part C (Cohort 7 only), use of nirsevimab ≥6 months beforeDay 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 allergicreaction of any severity to a previous dose of an mRNA vaccine or any of itscomponents (including polyethylene glycol or immediate allergic reaction of anyseverity to polysorbate).

  • Has a medical condition that, according to the Investigator's judgment, may poseadditional risk as a result of participation, interfere with safety assessments, orinterfere with interpretation of results.

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

Study Design

Total Participants: 310
Treatment Group(s): 4
Primary Treatment: mRNA-1345
Phase: 1
Study Start date:
February 15, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Centro Medico IPAM S.A.

    Rosario, Santa Fe S2000
    Argentina

    Site Not Available

  • Hospital De Nino Jesus

    San Miguel de Tucumán, Tucumán 4000
    Argentina

    Site Not Available

  • Sanatorio Finochietto

    Buenos Aires, C1425EFD
    Argentina

    Site Not Available

  • Queensland Children&amp;apos;s Hospital

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Queensland Children's Hospital

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Women's and Children's Hospital (WCH)

    North Adelaide, South Australia 5006
    Australia

    Site Not Available

  • Monash Children's Hospital

    Melbourne, Victoria 3168
    Australia

    Site Not Available

  • Telethon Kids Institute

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • BC Children's Hospital - Vaccine Evaluation Centre - Neonatology

    Vancouver, British Columbia V5Z 4H4
    Canada

    Site Not Available

  • Dalhousie University IWK Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • London Health Sciences Centre - Victoria Hospital

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Universite de Montreal - Centre Hospitalier Universitaire (CHU) Sainte-Justine

    Montreal, Quebec
    Canada

    Site Not Available

  • Clínica de la Costa

    Barranquilla, Atlántico
    Colombia

    Site Not Available

  • Fundacion Hospital Universidad del Norte

    Barranquilla, Atlántico 80007
    Colombia

    Site Not Available

  • Centro de Atención e Investigación Médica S.A.S. - CAIMED CHIA

    Yopal, Casanare 850001
    Colombia

    Site Not Available

  • Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S - Clinical Trials

    Cali, 760013
    Colombia

    Site Not Available

  • SIA Vidzemes Bernu Veselibas Centrs "Apelsins"

    Valmiera, LV-4201
    Latvia

    Site Not Available

  • SIA Vidzemes Bernu Veselibas Centrs &quot;Apelsins&quot;

    Valmiera, LV-4201
    Latvia

    Site Not Available

  • CEVAXIN David

    David, Chiriquí 0401
    Panama

    Site Not Available

  • CEVAXIN Chorrera

    La Chorrera, Panama Oeste
    Panama

    Site Not Available

  • CEVAXIN Chorrera

    Chorrera,
    Panama

    Site Not Available

  • CEVAXIN 24 de Diciembre

    Ciudad de Panamá,
    Panama

    Site Not Available

  • CEVAXIN Avenida Mexico

    Panama City, 0801
    Panama

    Site Not Available

  • Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy

    Trzebnica, Dolnoslaskie 55-100
    Poland

    Site Not Available

  • Vistamed

    Wroclaw, Dolnoslaskie 53-149
    Poland

    Site Not Available

  • Centrum Badań Klinicznych JCI Jagiellońskie Centrum Innowacji Sp. z o.o.

    Krakow, Malopolskie 30-389
    Poland

    Site Not Available

  • Gdanskie Centrum Zdrowia Sp. z.o.o.

    Gdansk, Pomorskie 80-542
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Krakow, 30-349
    Poland

    Site Not Available

  • Josha Research

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Shandukani Research CRS

    Hillbrow, Gauteng 2001
    South Africa

    Site Not Available

  • Wits Health Consortium

    Johannesburg, Gauteng 2013
    South Africa

    Site Not Available

  • Setshaba Research centre

    Pretoria, Gauteng 152
    South Africa

    Site Not Available

  • Setshaba Research centre

    Soshanguve, Gauteng 0152
    South Africa

    Site Not Available

  • wits Health Consortium

    Soweto, Gauteng P.O. Berthsham 2013
    South Africa

    Site Not Available

  • Family Centre for Research with Ubuntu (FAMCRU)- Tygerberg

    Cape Town, Western Cape 7440
    South Africa

    Site Not Available

  • Practice Dr Jan Vermeulen

    Cape Town, Western Cape 7530
    South Africa

    Site Not Available

  • Complexo Hospitalario Universitario De Santiago

    Santiago de Compostela, A Coruña 15706
    Spain

    Site Not Available

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid 28911
    Spain

    Site Not Available

  • Hospital Universitario Arnau de Vilanova

    Lleida, 25198
    Spain

    Site Not Available

  • Hospital Carlos III-Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Quironsalud Malaga

    Málaga, 29015
    Spain

    Site Not Available

  • Bristol Royal Hospital for Children

    Bristol, Bristol, City Of BS2 8AE
    United Kingdom

    Site Not Available

  • Egin Research

    High Wycombe, Buckinghamshire HP112QW
    United Kingdom

    Site Not Available

  • Alder Hey NHS Foundation Trust - Pharmacy Clinical Trials

    Liverpool, L12 2AP
    United Kingdom

    Site Not Available

  • Imperial College London and Imperial College Healthcare NHS

    London,
    United Kingdom

    Site Not Available

  • St George's Hospital

    London, SW170RE
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospitals

    Norwich, NR4 7UY
    United Kingdom

    Site Not Available

  • John Radcliffe Hospital

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • SEC Clinical Research

    Andalusia, Alabama 36420
    United States

    Site Not Available

  • Los Angeles Children's Hospital

    Los Angeles, California 90095
    United States

    Site Not Available

  • Matrix Clinical Research

    Los Angeles, California 90057
    United States

    Site Not Available

  • Velocity Clinical Research, Denver

    Englewood, Colorado 80110
    United States

    Site Not Available

  • Meridian Clinical Research

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Prohealth Research Center

    Doral, Florida 33166
    United States

    Site Not Available

  • University Of Florida Health Science Center

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Accel Research Sites - Nona Pediatric Center

    Orlando, Florida 32829-8070
    United States

    Site Not Available

  • SEC Clinical Research

    Pensacola, Florida 32501
    United States

    Site Not Available

  • Wake Research

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Clinical Research Prime

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • MedPharmics - Platinum - PPDS

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • Massachusetts Gen Hosp-Ped Pul

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • UMASS Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Umass Memorial Medical Center

    Worcester, Massachusetts 01655-0002
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202-2608
    United States

    Site Not Available

  • Great Lakes Research Institute

    Southfield, Michigan 48075-5400
    United States

    Site Not Available

  • Pediatric Specialty Care Discovery Clinic

    Minneapolis, Minnesota 55454-1404
    United States

    Site Not Available

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Meridian Clinical Research

    Hastings, Nebraska 68901-2640
    United States

    Site Not Available

  • Be Well Clinical Studies, LLC

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Duke Vaccine and Trials Unit

    Durham, North Carolina 27703
    United States

    Site Not Available

  • M3-Emerging Medical Research

    Durham, North Carolina 27704
    United States

    Site Not Available

  • Wake Research

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Bay Colony Pediatrics

    Dickinson, North Dakota 77539
    United States

    Site Not Available

  • Dayton Clinical Research

    Dayton, Ohio 45409
    United States

    Site Not Available

  • Senders Pediatrics

    South Euclid, Ohio 44121
    United States

    Site Not Available

  • Velocity Clinical Research - Providence

    Providence, Rhode Island 02886
    United States

    Site Not Available

  • Palmetto Pediatrics, PA

    North Charleston, South Carolina 29406-9170
    United States

    Site Not Available

  • Vanderbilt Vaccine Research Program

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center

    El Paso, Texas 79905
    United States

    Site Not Available

  • CyFair

    Houston, Texas 77065
    United States

    Site Not Available

  • Mercury Clinical Research, Inc.

    Houston, Texas 77054
    United States

    Site Not Available

  • Pediatric Associates

    Houston, Texas 77087
    United States

    Site Not Available

  • Village Pediatrics

    Plano, Texas 75024
    United States

    Site Not Available

  • Mercury Clinical Research, Inc.

    Richmond, Texas 77469-3348
    United States

    Site Not Available

  • Pediatric Center

    Richmond, Texas 77469
    United States

    Site Not Available

  • North Houston Internal Medicine &amp; Pediatric Clinic

    Tomball, Texas 77375
    United States

    Site Not Available

  • Childrens Hospital Regional Medical Center

    Seattle, Washington 98105
    United States

    Site Not Available

  • MultiCare Rockwood Main Clinic

    Spokane, Washington 99202-3649
    United States

    Site Not Available

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