Phase
Condition
Respiratory Syncytial Virus (Rsv)
Treatment
mRNA-1345
Nimenrix
mRNA-1365
Clinical Study ID
Ages 5-24 All Genders
Study Summary
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
Connect with a study center
Centro Medico IPAM S.A.
Rosario, Santa Fe S2000
ArgentinaSite Not Available
Hospital De Nino Jesus
San Miguel de Tucumán, Tucumán 4000
ArgentinaSite Not Available
Sanatorio Finochietto
Buenos Aires, C1425EFD
ArgentinaSite Not Available
Queensland Children&apos;s Hospital
South Brisbane, Queensland 4101
AustraliaSite Not Available
Queensland Children's Hospital
South Brisbane, Queensland 4101
AustraliaSite Not Available
Women's and Children's Hospital (WCH)
North Adelaide, South Australia 5006
AustraliaSite Not Available
Monash Children's Hospital
Melbourne, Victoria 3168
AustraliaSite Not Available
Telethon Kids Institute
Nedlands, Western Australia 6009
AustraliaSite Not Available
BC Children's Hospital - Vaccine Evaluation Centre - Neonatology
Vancouver, British Columbia V5Z 4H4
CanadaSite Not Available
Dalhousie University IWK Health Centre
Halifax, Nova Scotia B3K 6R8
CanadaSite Not Available
London Health Sciences Centre - Victoria Hospital
London, Ontario N6A 5W9
CanadaSite Not Available
Universite de Montreal - Centre Hospitalier Universitaire (CHU) Sainte-Justine
Montreal, Quebec
CanadaSite Not Available
Clínica de la Costa
Barranquilla, Atlántico
ColombiaSite Not Available
Fundacion Hospital Universidad del Norte
Barranquilla, Atlántico 80007
ColombiaSite Not Available
Centro de Atención e Investigación Médica S.A.S. - CAIMED CHIA
Yopal, Casanare 850001
ColombiaSite Not Available
Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S - Clinical Trials
Cali, 760013
ColombiaSite Not Available
SIA Vidzemes Bernu Veselibas Centrs "Apelsins"
Valmiera, LV-4201
LatviaSite Not Available
SIA Vidzemes Bernu Veselibas Centrs "Apelsins"
Valmiera, LV-4201
LatviaSite Not Available
CEVAXIN David
David, Chiriquí 0401
PanamaSite Not Available
CEVAXIN Chorrera
La Chorrera, Panama Oeste
PanamaSite Not Available
CEVAXIN Chorrera
Chorrera,
PanamaSite Not Available
CEVAXIN 24 de Diciembre
Ciudad de Panamá,
PanamaSite Not Available
CEVAXIN Avenida Mexico
Panama City, 0801
PanamaSite Not Available
Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy
Trzebnica, Dolnoslaskie 55-100
PolandSite Not Available
Vistamed
Wroclaw, Dolnoslaskie 53-149
PolandSite Not Available
Centrum Badań Klinicznych JCI Jagiellońskie Centrum Innowacji Sp. z o.o.
Krakow, Malopolskie 30-389
PolandSite Not Available
Gdanskie Centrum Zdrowia Sp. z.o.o.
Gdansk, Pomorskie 80-542
PolandSite Not Available
Centrum Medyczne Plejady
Krakow, 30-349
PolandSite Not Available
Josha Research
Bloemfontein, Free State 9301
South AfricaSite Not Available
Shandukani Research CRS
Hillbrow, Gauteng 2001
South AfricaSite Not Available
Wits Health Consortium
Johannesburg, Gauteng 2013
South AfricaSite Not Available
Setshaba Research centre
Pretoria, Gauteng 152
South AfricaSite Not Available
Setshaba Research centre
Soshanguve, Gauteng 0152
South AfricaSite Not Available
wits Health Consortium
Soweto, Gauteng P.O. Berthsham 2013
South AfricaSite Not Available
Family Centre for Research with Ubuntu (FAMCRU)- Tygerberg
Cape Town, Western Cape 7440
South AfricaSite Not Available
Practice Dr Jan Vermeulen
Cape Town, Western Cape 7530
South AfricaSite Not Available
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, A Coruña 15706
SpainSite Not Available
Hospital Universitario Severo Ochoa
Leganés, Madrid 28911
SpainSite Not Available
Hospital Universitario Arnau de Vilanova
Lleida, 25198
SpainSite Not Available
Hospital Carlos III-Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Quironsalud Malaga
Málaga, 29015
SpainSite Not Available
Bristol Royal Hospital for Children
Bristol, Bristol, City Of BS2 8AE
United KingdomSite Not Available
Egin Research
High Wycombe, Buckinghamshire HP112QW
United KingdomSite Not Available
Alder Hey NHS Foundation Trust - Pharmacy Clinical Trials
Liverpool, L12 2AP
United KingdomSite Not Available
Imperial College London and Imperial College Healthcare NHS
London,
United KingdomSite Not Available
St George's Hospital
London, SW170RE
United KingdomSite Not Available
Norfolk and Norwich University Hospitals
Norwich, NR4 7UY
United KingdomSite Not Available
John Radcliffe Hospital
Oxford, OX3 9DU
United KingdomSite Not Available
Southampton General Hospital
Southampton, SO16 6YD
United KingdomSite Not Available
SEC Clinical Research
Andalusia, Alabama 36420
United StatesSite Not Available
Los Angeles Children's Hospital
Los Angeles, California 90095
United StatesSite Not Available
Matrix Clinical Research
Los Angeles, California 90057
United StatesSite Not Available
Velocity Clinical Research, Denver
Englewood, Colorado 80110
United StatesSite Not Available
Meridian Clinical Research
Washington, District of Columbia 20016
United StatesSite Not Available
Prohealth Research Center
Doral, Florida 33166
United StatesSite Not Available
University Of Florida Health Science Center
Jacksonville, Florida 32209
United StatesSite Not Available
Accel Research Sites - Nona Pediatric Center
Orlando, Florida 32829-8070
United StatesSite Not Available
SEC Clinical Research
Pensacola, Florida 32501
United StatesSite Not Available
Wake Research
Sandy Springs, Georgia 30328
United StatesSite Not Available
Clinical Research Prime
Idaho Falls, Idaho 83404
United StatesSite Not Available
MedPharmics - Platinum - PPDS
Lafayette, Louisiana 70508
United StatesSite Not Available
Massachusetts Gen Hosp-Ped Pul
Boston, Massachusetts 02114
United StatesSite Not Available
UMASS Chan Medical School
Worcester, Massachusetts 01655
United StatesSite Not Available
Umass Memorial Medical Center
Worcester, Massachusetts 01655-0002
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202-2608
United StatesSite Not Available
Great Lakes Research Institute
Southfield, Michigan 48075-5400
United StatesSite Not Available
Pediatric Specialty Care Discovery Clinic
Minneapolis, Minnesota 55454-1404
United StatesSite Not Available
Washington University School of Medicine in St. Louis
Saint Louis, Missouri 63110
United StatesSite Not Available
Meridian Clinical Research
Hastings, Nebraska 68901-2640
United StatesSite Not Available
Be Well Clinical Studies, LLC
Lincoln, Nebraska 68516
United StatesSite Not Available
Duke Vaccine and Trials Unit
Durham, North Carolina 27703
United StatesSite Not Available
M3-Emerging Medical Research
Durham, North Carolina 27704
United StatesSite Not Available
Wake Research
Raleigh, North Carolina 27612
United StatesSite Not Available
Bay Colony Pediatrics
Dickinson, North Dakota 77539
United StatesSite Not Available
Dayton Clinical Research
Dayton, Ohio 45409
United StatesSite Not Available
Senders Pediatrics
South Euclid, Ohio 44121
United StatesSite Not Available
Velocity Clinical Research - Providence
Providence, Rhode Island 02886
United StatesSite Not Available
Palmetto Pediatrics, PA
North Charleston, South Carolina 29406-9170
United StatesSite Not Available
Vanderbilt Vaccine Research Program
Nashville, Tennessee 37232
United StatesSite Not Available
Texas Tech University Health Sciences Center
El Paso, Texas 79905
United StatesSite Not Available
CyFair
Houston, Texas 77065
United StatesSite Not Available
Mercury Clinical Research, Inc.
Houston, Texas 77054
United StatesSite Not Available
Pediatric Associates
Houston, Texas 77087
United StatesSite Not Available
Village Pediatrics
Plano, Texas 75024
United StatesSite Not Available
Mercury Clinical Research, Inc.
Richmond, Texas 77469-3348
United StatesSite Not Available
Pediatric Center
Richmond, Texas 77469
United StatesSite Not Available
North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas 77375
United StatesSite Not Available
Childrens Hospital Regional Medical Center
Seattle, Washington 98105
United StatesSite Not Available
MultiCare Rockwood Main Clinic
Spokane, Washington 99202-3649
United StatesSite Not Available
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