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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05085366
Registration number
NCT05085366
Ethics application status
Date submitted
7/10/2021
Date registered
20/10/2021
Date last updated
24/04/2024
Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
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Scientific 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
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Secondary ID [1]
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2020-006051-17
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Secondary ID [2]
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mRNA-1647-P301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cytomegalovirus Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - mRNA-1647
Other interventions - Placebo
Experimental: mRNA-1647 - Participants will receive mRNA-1647 vaccine by intramuscular (IM) injection on Day 1, Day 57, and Day 169.
Placebo Comparator: Placebo - Participants will receive mRNA-1647 vaccine matching placebo by IM injection on Day 1, Day 57, and Day 169.
Other interventions: mRNA-1647
Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline)
Other interventions: Placebo
0.9% sodium chloride (normal saline) injection
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Seroconversion From a Negative to a Positive Result for Serum Immunoglobulin G (IgG) Against Antigens not Encoded by mRNA-1647
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Assessment method [1]
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Timepoint [1]
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Day 197 (28 days after the third injection) up to Day 887 (24 months after the third injection)
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Primary outcome [2]
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Number of Participants With Solicited Adverse Reactions (ARs)
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Assessment method [2]
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Timepoint [2]
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Up to 176 days (7 days after each injection)
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Primary outcome [3]
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Number of Participants With Unsolicited Adverse Events (AEs)
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Assessment method [3]
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Timepoint [3]
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Up to 197 days (28 days after each injection)
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Primary outcome [4]
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Number of Participants With Medically-Attended Adverse Events (MAAEs)
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Assessment method [4]
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0
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Timepoint [4]
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Day 1 through 6 months after the last injection (up to 347 days)
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Primary outcome [5]
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Number of Participants With Adverse Event of Special Interests (AESIs) and Serious Adverse Events (SAEs)
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Assessment method [5]
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Timepoint [5]
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Day 1 through Day 887
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Primary outcome [6]
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Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb)
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Assessment method [6]
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Timepoint [6]
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Month 30 up to Month 54
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Primary outcome [7]
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Geometric Mean Concentration (GMC) of Binding Antibody
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Assessment method [7]
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0
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Timepoint [7]
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Month 30 up to Month 54
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Primary outcome [8]
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Seroconversion From a Negative to a Positive Result for Serum IgG Against Antigens not Encoded by mRNA-1647
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Assessment method [8]
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0
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Timepoint [8]
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Day 887 up to Day 1607
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Secondary outcome [1]
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GMTs of Antigen-Specific nAb
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Assessment method [1]
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0
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Timepoint [1]
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Day 1, Months 3, 7, 12, 18, 24, and 30
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Secondary outcome [2]
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GMC of Antigen-Specific Binding Antibody
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Assessment method [2]
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Timepoint [2]
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Day 1, Months 3, 7, 12, 18, 24, and 30
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Secondary outcome [3]
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Number of Participants with AEs leading to Study Discontinuation, SAEs and Deaths
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Assessment method [3]
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0
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Timepoint [3]
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Day 887 through end of study (up to Day 1607)
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Eligibility
Key inclusion criteria
Key
- 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 study
injection, and completed the final study visit in the main study.
- Consenting participants in mRNA-1647-P301 main study who were CMV-seronegative at
baseline, received all 3 study injections, and completed the final study visit in the
main study.
Key
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Minimum age
16
Years
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Maximum age
40
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
6/04/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
7454
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,North South WalesQLD,VIC,WA
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Recruitment hospital [1]
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Paratus Clinical Research - Bruce
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Recruitment hospital [2]
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Paratus Clinical Research - Western Sydney - Blacktown
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Recruitment hospital [3]
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Northern Beaches Clinical Research - Brookvale
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Recruitment hospital [4]
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Northside Health - Coffs Harbour
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Recruitment hospital [5]
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Kanwal Medical Complex - Kanwal
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Recruitment hospital [6]
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Hunter Diabetes Centre - Merewether
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Recruitment hospital [7]
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Emeritus Research - Botany
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Recruitment hospital [8]
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University of the Sunshine Coast, Health Hub Morayfield - Morayfield
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Recruitment hospital [9]
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University of the Sunshine Coast - Sippy Downs
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Recruitment hospital [10]
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USC Southbank - Southbank
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Recruitment hospital [11]
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Emeritus Research - Camberwell
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Recruitment hospital [12]
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Barwon Health - Geelong
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Recruitment hospital [13]
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The University of Melbourne - Melbourne
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Recruitment hospital [14]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [15]
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Telethon Kids Institute - Nedlands
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Recruitment postcode(s) [1]
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2617 - Bruce
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Recruitment postcode(s) [2]
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2148 - Blacktown
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Recruitment postcode(s) [3]
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2100 - Brookvale
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Recruitment postcode(s) [4]
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2450 - Coffs Harbour
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Recruitment postcode(s) [5]
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2259 - Kanwal
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Recruitment postcode(s) [6]
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2291 - Merewether
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Recruitment postcode(s) [7]
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02019 - Botany
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Recruitment postcode(s) [8]
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4506 - Morayfield
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Recruitment postcode(s) [9]
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4556 - Sippy Downs
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Recruitment postcode(s) [10]
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4101 - Southbank
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Recruitment postcode(s) [11]
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03124 - Camberwell
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Recruitment postcode(s) [12]
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3220 - Geelong
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Recruitment postcode(s) [13]
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3000 - Melbourne
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Recruitment postcode(s) [14]
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3050 - Parkville
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Recruitment postcode(s) [15]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Illinois
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Central District Of Israel
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Israel
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Israel
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Israel
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Kansai
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Spain
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Andalusia
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Spain
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Catalonia
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Spain
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Galicia
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Spain
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Madrird
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Spain
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Madrid
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United Kingdom
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Cleveland
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United Kingdom
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England
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United Kingdom
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Northamptonshire
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United Kingdom
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Northumberland
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United Kingdom
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South West England
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
ModernaTX, Inc.
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05085366
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Contacts
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05085366
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