Clinical trial NCT05085366: A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
Official title: A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Cytomegalovirus Infection
Keywords: mRNA-1647
Moderna
Cytomegalovirus
CMV
Cytomegalovirus Vaccine
Cytomegalovirus Infections
Cytomegalovirus Congenital
Virus Diseases
Infection Viral
DNA Virus Infections
Messenger RNA
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-20
Enrollment: 7454
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension sub study is to extend the observation period of the main study and to evaluate the longer-term immune persistence of mRNA-1647 vaccine administered to CMV-seronegative females who complete mRNA-1647-P301 main study and to assess for CMV seroconversion in CMV-seronegative participants who did not seroconvert during mRNA-1647-P301 main study. No interventional vaccine will be administered in the extension study.


Eligibility criteria: Key Inclusion Criteria:

* Participants aged ≥20 years, has or anticipates having direct exposure within 7 months after the planned first dose (in the home, socially, or occupationally) to at least 1 child ≤5 years of age. Direct exposure is defined as either participant is the parent, or participant has close contact (feeding, diaper changes, childcare/supervision) for at least 8 hours per week.
* CMV-seronegative Cohort is CMV-seronegative based on CMV testing at Screening.
* CMV-seropositive Cohort is CMV-seropositive based on CMV testing at Screening.
* Investigator assessment confirms that the participant (including in the case of an emancipated minor), or parent(s)/legally acceptable representative (LAR)(s), as applicable, understand and are willing and physically able to comply with protocol-mandated follow-up including all study visits and procedures anticipated during the 30 month study period.
* Female participants of child-bearing potential: Urine pregnancy test is negative at Screening and negative on the day of the first injection (Day 1). If the participant is sexually active with men, has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1) and agrees to continue adequate contraception through 3 months following the third study injection (Month 9/Day 257).

Extension substudy:

* All consenting participants in mRNA-1647-P301 main study who were CMV-seronegative at baseline and did not seroconvert during the main study, received at least one injection of either mRNA-1647 or placebo, and completed the final study visit in the main study.
* Consenting participants in mRNA-1647-P301 main study who were CMV-seropositive at baseline, received all 3 study injections, and completed the final study visit in the main study.

Key Exclusion Criteria:

* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
* Received or plans to receive any nonstudy vaccine \<28 days prior to and after any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
* Any COVID-19 primary vaccination series must have been completed a minimum 28 days prior to receiving any dose of the study injection.
* COVID-19 vaccines (including any booster dose, regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
* Influenza vaccines may be administered \> 14 days prior to or after any study injection.
* Received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to the day of first injection (Day 1) (for corticosteroids, ≥5 milligrams (mg)/day of prednisone equivalent) or plans to do so during the course of the study. Inhaled, nasal, and topical steroids are allowed. Stable immunomodulator regimens used for managing environmental allergies are allowed.
* Receipt of an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) \<2 weeks prior to the day of first injection or plans to do so during the course of the study.
* Previous receipt of an investigational CMV vaccine.
* Receipt of systemic immunoglobulins or blood products \<3 months prior to the day of first injection.
* Participated in an interventional clinical study \<28 days prior to the day of first injection (Day 1) or plans to do so while enrolled in this study.
* Participant has donated ≥450 milliliters (mL) of blood products \<28 days prior to Screening.
* Participant is a member of study team or is an immediate family member or household member of study personnel.

Extension substudy:

* Receipt of any CMV vaccine other than mRNA-1647.
* Diagnosis or condition that, in the judgment of the Investigator, may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures, including any medical, psychiatric, or occupational condition that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.

Primary outcomes:
measure: Seroconversion From a Negative to a Positive Result for Serum Immunoglobulin G (IgG) Against Antigens not Encoded by mRNA-1647
timeFrame: Day 197 (28 days after the third injection) up to Day 887 (24 months after the third injection)
measure: Number of Participants With Solicited Adverse Reactions (ARs)
timeFrame: Up to 176 days (7 days after each injection)
measure: Number of Participants With Unsolicited Adverse Events (AEs)
timeFrame: Up to 197 days (28 days after each injection)
measure: Number of Participants With Medically-Attended Adverse Events (MAAEs)
timeFrame: Day 1 through 6 months after the last injection (up to 347 days)
measure: Number of Participants With Adverse Event of Special Interests (AESIs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 through Day 887
measure: Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb)
timeFrame: Month 30 up to Month 54
measure: Geometric Mean Concentration (GMC) of Binding Antibody
timeFrame: Month 30 up to Month 54
measure: Seroconversion From a Negative to a Positive Result for Serum IgG Against Antigens not Encoded by mRNA-1647
timeFrame: Day 887 up to Day 1607
Secondary outcomes:
measure: GMTs of Antigen-Specific nAb
timeFrame: Day 1, Months 3, 7, 12, 18, 24, and 30
measure: GMC of Antigen-Specific Binding Antibody
timeFrame: Day 1, Months 3, 7, 12, 18, 24, and 30
measure: Number of Participants with AEs leading to Study Discontinuation, SAEs and Deaths
timeFrame: Day 887 through end of study (up to Day 1607)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates Inc
state: Alabama
city: Birmingham
country: United States
facility: Accel Research Site - Achieve - Birmingham - ERN - PPDS
state: Alabama
city: Dothan
country: United States
facility: SEC Clinical Research LLC - Dothan - ClinEdge - PPDS
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research
state: Alabama
city: Chandler
country: United States
facility: Chandler Clinical Trials, LLC
state: Arizona
city: Mesa
country: United States
facility: Arizona Clinical Trials
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Clinical LLC
state: Arizona
city: Phoenix
country: United States
facility: MedPharmics, LLC
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute LLC
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute LLC
state: Arizona
city: Surprise
country: United States
facility: Epic Medical Research Arizona
state: Arizona
city: Tempe
country: United States
facility: Voyage Medical
state: Arizona
city: Tempe
country: United States
facility: Hope Research Institute LLC
state: Arizona
city: Tucson
country: United States
facility: Tucson Neuroscience Research - M3 WR - ERN - PPDS
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health-Tucson
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management - ClinEdge - PPDS
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas - Clinedge - PPDS
state: Arkansas
city: Banning
country: United States
facility: Velocity Clinical Research - Banning
state: California
city: Chula Vista
country: United States
facility: Velocity Clinical Research - Chula Vista
state: California
city: Fair Oaks
country: United States
facility: Apex Research Group
state: California
city: Fullerton
country: United States
facility: Ascada Research LLC
state: California
city: La Mesa
country: United States
facility: Paradigm Clinical Research Center
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research - San Diego
state: California
city: Long Beach
country: United States
facility: Long Beach Research Institute, LLC
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services Inc.
state: California
city: Montclair
country: United States
facility: Catalina Research Institute LLC
state: California
city: North Hollywood
country: United States
facility: Carbon Health- NoHo West Urgent Care and Primary Care
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Institute, Inc. - ClinEdge
state: California
city: Rolling Hills Estates
country: United States
facility: Smart Cures Clinical Research
state: California
city: Sacramento
country: United States
facility: Northern California Research Corp
state: California
city: San Diego
country: United States
facility: Womens Healthcare Research Corporation ERN PPDS
state: California
city: Santa Clarita
country: United States
facility: Care Access Research - Santa Clarita
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Management Services, LLC
state: California
city: Valley Village
country: United States
facility: Bayview Research Group
state: California
city: West Covina
country: United States
facility: Next Level Clinical Trials
state: California
city: Aurora
country: United States
facility: Care Access Research - Aurora
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research Institute Inc - ClinEdge
state: Colorado
city: Bridgeport
country: United States
facility: New England Research Associates LLC - ERN - PPDS
state: Connecticut
city: Milford
country: United States
facility: Clinical Research Consultants LLC
state: Connecticut
city: Washington
country: United States
facility: Emerson Clinical Research Institute LLC - Kennedy St
state: District of Columbia
city: Coconut Creek
country: United States
facility: Invictus Clinical Research Group, LLC
state: Florida
city: Coral Gables
country: United States
facility: Luna Research LLC
state: Florida
city: Coral Gables
country: United States
facility: Herco Medical and Research Center, Inc.
state: Florida
city: Coral Springs
country: United States
facility: Precision Clinical Research, LLC
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research
state: Florida
city: Doral
country: United States
facility: Unique Clinical Trials, LLC
state: Florida
city: Edgewater
country: United States
facility: Velocity Clinical Research, New Smyrna Beach
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research, Inc
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research - ClinEdge - PPDS
state: Florida
city: Miami
country: United States
facility: Florida International Medical Research
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Miami
country: United States
facility: Spotlight Research Center, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Beach Clinical Research
state: Florida
city: Panama City
country: United States
facility: Emerald Coast OBGYN Clinical Research
state: Florida
city: Pembroke Pines
country: United States
facility: Ideal Clinical Research, Inc. - ClinEdge - PPDS
state: Florida
city: Plantation
country: United States
facility: Precision Clinical Research - Plantation
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Global Clinical Professionals
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Health Care
state: Florida
city: Atlanta
country: United States
facility: CVS HealthHub - Atlanta S
state: Georgia
city: Atlanta
country: United States
facility: CVS HealthHub - Atlanta
state: Georgia
city: Chamblee
country: United States
facility: Tekton Research - Georgia - Platinum
state: Georgia
city: Columbus
country: United States
facility: Centricity Research - Roswel
state: Georgia
city: Dacula
country: United States
facility: CVS HealthHub - Dacula
state: Georgia
city: Decatur
country: United States
facility: IResearch Atlanta LLC
state: Georgia
city: Kennesaw
country: United States
facility: CVS HealthHub - Kennesaw
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America - ClinEdge - PPDS
state: Georgia
city: McDonough
country: United States
facility: CVS HealthHub - Mcdonough
state: Georgia
city: Newnan
country: United States
facility: CVS HealthHub - Newman
state: Georgia
city: Norcross
country: United States
facility: One Health Research Clinic, Inc.
state: Georgia
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS
state: Georgia
city: Savannah
country: United States
facility: CVS HealthHub - Savannah
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime - Clinedge
state: Idaho
city: Meridian
country: United States
facility: Velocity Clinical Research
state: Idaho
city: Oak Brook
country: United States
facility: Affinity Health
state: Illinois
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Hammond
country: United States
facility: ASHA Clinical Research - ClinEdge
state: Indiana
city: Mishawaka
country: United States
facility: Del Pilar Medical and Urgent Care
state: Indiana
city: Des Moines
country: United States
facility: Iowa Clinic
state: Iowa
city: Lenexa
country: United States
facility: Johnson Country Clin-Trials
state: Kansas
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Lexington
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kentucky
city: Metairie
country: United States
facility: Velocity Clinical Research - Covington
state: Louisiana
city: Elkridge
country: United States
facility: Centennial Medical Group - Elkridge - Rx Trials
state: Maryland
city: Rockville
country: United States
facility: Meridian Clinical Research-(Rockville Maryland)
state: Maryland
city: Brookline
country: United States
facility: DM Clinical Research - The Brook House
state: Massachusetts
city: Burlington
country: United States
facility: Skylight Health Research - Burlington
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research Inc
state: Massachusetts
city: Canton
country: United States
facility: Voyage Medical - Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Southfield
country: United States
facility: Great Lakes Research Institute
state: Michigan
city: Southfield
country: United States
facility: DM Clinical Research - Southfield
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc - CRN - PPDS
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Clinical Research Unit
state: Minnesota
city: Gulfport
country: United States
facility: MedPharmics, LLC
state: Mississippi
city: Petal
country: United States
facility: MediSync Clinical Research Hattiesburg Clinic
state: Mississippi
city: Great Falls
country: United States
facility: Boeson Research GTF - Great Falls
state: Montana
city: Kalispell
country: United States
facility: Boeson Research KAL - Kalispell - ERN - PPDS
state: Montana
city: Missoula
country: United States
facility: Boeson Research MSO - Missoula
state: Montana
city: Grand Island
country: United States
facility: Meridian Clinical Research (Grand Island, Nebraska)
state: Nebraska
city: Hastings
country: United States
facility: Meridian Clinical Research (Hastings, Nebraska)
state: Nebraska
city: Lincoln
country: United States
facility: Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research (Norfolk-Nebraska)
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research-(Omaha Nebraska)
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center Of Nevada
state: Nevada
city: Irvington
country: United States
facility: Med Clinic Research Partners, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials Inc.
state: New Mexico
city: Albuquerque
country: United States
facility: MedPharmics, LLC. - Albuquerque
state: New Mexico
city: Binghamton
country: United States
facility: Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
state: New York
city: E. Amherst
country: United States
facility: WellNow Urgent Care Clinical Research
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research - M3 WR - ERN - PPDS
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research (Venus St)
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc - M3 WR - ERN - PPDS
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Cincinnati
country: United States
facility: CTI Clinical Research Center - ClinEdge - PPDS
state: Ohio
city: Cincinnati
country: United States
facility: Meridian Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center-Goodman St
state: Ohio
city: Columbus
country: United States
facility: ClinOhio Research Services
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc.
state: Ohio
city: Columbus
country: United States
facility: WellNow Urgent Care & Research - Huber Heights
state: Ohio
city: Dayton
country: United States
facility: PriMed Clinical Research - ClinEdge
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: Chickasha
country: United States
facility: Epic Medical Research Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research - Oklahoma - Platinum
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research - Medford
state: Oregon
city: Columbia
country: United States
facility: SPICA Clinical Research
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston LLC
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: ARC Clinical Research at Wilson Parke
state: Texas
city: Austin
country: United States
facility: Premier Family Physicians - Austin - Hunt
state: Texas
city: Austin
country: United States
facility: ARC Clinical Research at William Cannon
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Beaumont
country: United States
facility: Gadolin Research LLC
state: Texas
city: Beaumont
country: United States
facility: REX Clinical Trials
state: Texas
city: Beaumont
country: United States
facility: Tekton Research - Beaumont
state: Texas
city: Cedar Park
country: United States
facility: Velocity Clinical Research - Austin
state: Texas
city: Dallas
country: United States
facility: Global Medical Research
state: Texas
city: Dallas
country: United States
facility: Zenos Clinical Research
state: Texas
city: El Paso
country: United States
facility: ANRC Research
state: Texas
city: Frisco
country: United States
facility: Village Health Partners Frisco Medical Village
state: Texas
city: Houston
country: United States
facility: Trio Clinical Trials LLC
state: Texas
city: Houston
country: United States
facility: Vilo Research Group, L.L.C.
state: Texas
city: Houston
country: United States
facility: New Horizon Medical Group, LLC
state: Texas
city: Irving
country: United States
facility: Cedar Health Research - Fort Worth - PPDS
state: Texas
city: Keller
country: United States
facility: Helios CCR, Inc.-keller-PPDS
state: Texas
city: League City
country: United States
facility: University of Texas Medical Branch - Bay Colony, SIVS Clinical Trials Program
state: Texas
city: McAllen
country: United States
facility: BRCR Medical Center Inc - McAllen
state: Texas
city: Missouri City
country: United States
facility: Synergy Group US, LLC
state: Texas
city: Pflugerville
country: United States
facility: Austin Regional Clinic ARC Clinical Research at Kelly Lane
state: Texas
city: Pharr
country: United States
facility: GLRI McAllen Research
state: Texas
city: Plano
country: United States
facility: ACRC Trials - Independence Parkway - Plano - Hunt - PPDS
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc. - HyperCor
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Victoria
country: United States
facility: Crossroads Clinical Research (Victoria)
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials LLC
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Riverton
country: United States
facility: Granger Medical Clinic - Riverton
state: Utah
city: Salt Lake City
country: United States
facility: Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: Foothill Family Clinic - South Clinic
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads Inc. - ClinEdge
state: Virginia
city: Norfolk
country: United States
facility: York Clinical Research
state: Virginia
city: Suffolk
country: United States
facility: David Ramstad Associates Research - IACT - HyperCore - PPDS
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
city: Spokane
country: United States
facility: Velocity Clinical Research - Spokane - PPDS
state: Washington
city: Madison
country: United States
facility: University Of Wisconsin - Madison
state: Wisconsin
city: Bruce
country: Australia
facility: Paratus Clinical Research
state: Australian Capital Territory
city: Blacktown
country: Australia
facility: Paratus Clinical Research - Western Sydney
state: New South Wales
city: Brookvale
country: Australia
facility: Northern Beaches Clinical Research
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Northside Health
state: New South Wales
city: Kanwal
country: Australia
facility: Kanwal Medical Complex
state: New South Wales
city: Merewether
country: Australia
facility: Hunter Diabetes Centre
state: New South Wales
city: Botany
country: Australia
facility: Emeritus Research
state: North South Wales
city: Morayfield
country: Australia
facility: University of the Sunshine Coast, Health Hub Morayfield
state: Queensland
city: Sippy Downs
country: Australia
facility: University of the Sunshine Coast
state: Queensland
city: Southbank
country: Australia
facility: USC Southbank
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Melbourne
country: Australia
facility: The University of Melbourne
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Telethon Kids Institute
state: Western Australia
city: Gent
country: Belgium
facility: Center for Vaccinology (CEVAC)
state: Oost-Vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint-Lucas Brugge
state: West-Vlaanderen
city: Liège
country: Belgium
facility: CHU de Liège
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology
state: Nova Scotia
city: Burlington
country: Canada
facility: LMC Manna Research - Burlington - HyperCore - PPDS
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil K. Gupta Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: Centricity Research - Toronto
state: Ontario
city: Levis
country: Canada
facility: Centricity Research - Quebec - HyperCore - PPDS
state: Quebec
city: Mirabel
country: Canada
facility: Centricity Research - Mirabel - HyperCore - PPDS
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Pierrefonds
country: Canada
facility: McGill University Health Centre-Vaccine Study Centre
state: Quebec
city: Pointe-Claire
country: Canada
facility: Centricity Research - Montreal - HyperCore - PPDS
state: Quebec
city: Québec City
country: Canada
facility: Diex Recherche - Québec - HyperCore
state: Quebec
city: Saint-Charles-Borromée
country: Canada
facility: Diex Recherche - Joilette - HyperCore - PPDS
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche - Sherbrooke - HyperCore
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Recherche - Victoriaville - HyperCore
state: Quebec
city: Tallinn
country: Estonia
facility: CCBR Clinical Research
state: Harjumaa
city: Tallinn
country: Estonia
facility: Al Mare Family Doctors Centre
state: Harjumaa
city: Tallinn
country: Estonia
facility: Merelahe Family Doctors Centre
state: Harjumaa
city: Paide
country: Estonia
facility: Vee Family Doctors Center Ltd
state: Järvamaa
city: Tartu
country: Estonia
facility: Clinical Research Centre Ltd.
state: Tartumaa
city: Seinäjoki
country: Finland
facility: Tampereen Yliopisto Seinajoen Rokotusklinikka
state: Etelä-Pohjanmaa
city: Helsinki
country: Finland
facility: Etelä Helsingin Rokotetutkimusklinikka
state: Etelä-Suomen Lään
city: Kokkola
country: Finland
facility: Kokkolan Rokotetutkimusklinikka
state: Keski-Pohjanmaa
city: Oulu
country: Finland
facility: Oulun Rokotetutkimusklinikka
state: Oulun Lääni
city: Tampere
country: Finland
facility: Tampereen Rokotetutkimusklinikka
state: Pirkanmaa
city: Pori
country: Finland
facility: Porin Rokotetutkimusklinikka
state: Satakunta
city: Espoo
country: Finland
facility: Espoon rokotetutkimusklinikka
state: Uusimaa
city: Helsinki
country: Finland
facility: Itä Helsingin Rokotetutkimusklinikka
state: Uusimaa
city: Järvenpää
country: Finland
facility: Järvenpään Rokotetutkimusklinikka
state: Uusimaa
city: Turku
country: Finland
facility: Turun Rokotetutkimusklinikka
state: Västra Finlands Län
city: Nantes
country: France
facility: CHRU Nantes
state: Pays De La Loire
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Departemental de Vendee
city: Limoges
country: France
facility: Centre Hospitalier et Universitaire de Limoges
city: Montpellier
country: France
facility: CHU Montpellier - Hôpital St Eloi
city: Paris
country: France
facility: Hopital Necker
city: Paris
country: France
facility: Groupe Hospitalier Cochin Saint Vincent de Paul
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Saint-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Etienne
city: Tours
country: France
facility: CHRU de Tours
city: Stuttgart
country: Germany
facility: TriDerm
state: Baden-Württemberg
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: Nordrhein-Westfalen
city: Geseke
country: Germany
facility: Frauenarztpraxis Erwin Göckeler-Leopold
state: North Rhine-Westphalia
city: Mainz
country: Germany
facility: Dermatologie Quist
state: Rhineland-Palatinate
city: Delitzsch
country: Germany
facility: Klifeck GmbH
state: Sachsen
city: Oldenburg in Holstein
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Reinfeld
country: Germany
facility: Praxis Reinfeld-Mitte
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Berliner Centrum für Reise- und Tropenmedizin BCRT GmbH
city: Hamburg
country: Germany
facility: Bernhard Nocht Centre for Clinical Trials (BNCCT)am Bernhard-Nocht-Institut für Tropenmedizin
city: Hamburg
country: Germany
facility: Velocity Clinical Research - Hamburg - PPDS
city: Hamburg
country: Germany
facility: Office of Klaus H. Peters, Dr.med
city: Leipzig
country: Germany
facility: Velocity Clniical Research Leipzip Gmbh
city: Leipzig
country: Germany
facility: AmBeNet GmbH
city: München
country: Germany
facility: Centrum Für Diagnostik und Gesundheit
city: Weinheim
country: Germany
facility: Medislim GmbH - Zentrum fuer Ambulante Klinische Forschung
city: Petah Tiqva
country: Israel
facility: Sheba Medical Center - PPDS
state: Central District Of Israel
city: Haifa
country: Israel
facility: Rambam Medical Center - PPDS
state: Haifa Hefa
city: Beer Yaakov
country: Israel
facility: Shamir Medical Center Assaf Harofeh
state: Rishon Lezion
city: Beer Sheva
country: Israel
facility: Soroka University Medical Centre
state: Tel Aviv District
city: Tel Aviv
country: Israel
facility: Maccabi Hashalom
state: Tel Aviv District
city: Jerusalem
country: Israel
facility: Hadassah Medical Center - PPDS
state: Yerushalayim Al Quds
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim Al Quds
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center PPDS
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori - MBBM - c/o Centro Maria Letizia Verga
city: Funabashi-shi
country: Japan
facility: Clinical Trial Site
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Clinical trial site
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Clinical Trial Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Clinical Trial Site
state: Hokkaido
city: Kobe-Shi
country: Japan
facility: Kobe University Hospital
state: Hyôgo
city: Osaka-shi Osaka
country: Japan
facility: Clinical trial site
state: Kansai
city: Habikino-shi
country: Japan
facility: Clinical Trial Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Clinical Trial Site
state: Osaka
city: Sakai-shi
country: Japan
facility: Clinical Trial Site
state: Osaka
city: Kawagoe-shi
country: Japan
facility: Clinical Trial Site
state: Saitama
city: Chuo-ku
country: Japan
facility: Clinical Trial Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Clinical Trial Site
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Clinical Trial Site
state: Tokyo
city: Shinjuku
country: Japan
facility: Clinical Trial Site
state: Tokyo
city: Taito-ku
country: Japan
facility: Clinical Trial Site
state: Tokyo
city: Cordoba
country: Spain
facility: C.H. Regional Reina Sofia
state: Andalusia
city: Malaga
country: Spain
facility: Hospital Quironsalud Malaga
state: Andalusia
city: Sevilla
country: Spain
facility: Instituto Hispalense de Pediatria
state: Andalusia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
state: Catalonia
city: Centelles
country: Spain
facility: ABS Centelles
state: Catalonia
city: Santiago de Compostela
country: Spain
facility: CHUS - H. Clinico U. de Santiago
state: Galicia
city: Mostoles
country: Spain
facility: Hospital HM Puerta del Sur
state: Madrird
city: Madrid
country: Spain
facility: Hospital Universitario La Paz.
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
state: Cleveland
city: London
country: United Kingdom
facility: William Harvey Clinical Research Centre
state: England
city: London
country: United Kingdom
facility: St George s Vaccine Institute
state: England
city: Corby
country: United Kingdom
facility: Lakeside Surgery
state: Northamptonshire
city: Newcastle upon Tyne
country: United Kingdom
facility: NIHR Patient Recruitment Centre: Newcastle
state: Northumberland
city: Bristol
country: United Kingdom
facility: St Michaels Hospital
state: South West England
city: Southampton
country: United Kingdom
facility: NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust
Study officials:
References:
citation: Kadambari S, Evans C, Lyall H. Congenital Infections: Priorities and Possibilities for Resource-limited Settings. Pediatr Infect Dis J. 2023 Feb 1;42(2):e45-e47. doi: 10.1097/INF.0000000000003710. Epub 2022 Sep 12. No abstract available.