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View trial details
Overview
Official protocol 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
Intervention/treatment:
Name given to the drug used in the clinical trial. This may be a code name, a chemical name of the active ingredient, a non-proprietary name or brand name.
MRNA-1647
Medical condition:
The disease or condition that's being studied in the clinical trial.
Protocol code:
An alpha-numeric sequence generated by the sponsor that can vary in length. Used as a reference to help identify a specific clinical trial protocol. Formerly referred to as 'protocol number'.
MRNA-1647-P301
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
257302
Status:
The status for the clinical trial as a whole. Note that the status for each site may be different and should always be confirmed with the clinical trial sponsor. Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal can include:
• Not yet recruiting - Participants are not yet being recruited or enrolled at any site.
• Recruiting - Participants are currently being recruited.
• Active, not recruiting - The clinical trial is ongoing but new participants are not currently being recruited or enrolled.
• On hold - The clinical trial has been temporarily stopped, but it may start again.
• Closed - The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again.
• Unknown - The status of the clinical trial has not been verified in the registry in the last 2 years. Please contact the sponsor.
• No match, ongoing - Please contact sponsor for status information.
• Other - Please contact sponsor for status information.
Closed
Approved:
The date that the clinical trial has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization was issued.
November 05, 2021
Trial phase:
The stage of a clinical trial, based on factors such as the objectives of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.
For more information see "Phases of drug trials" on the Definitions webpage
Phase 3
For more information:
ClinicalTrials.gov -
NCT05085366
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
The characteristics people must have or the requirements they must meet to participate in the clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating).
Review the exact criteria from the registry or the sponsor before making a decision to participate. The following values may be available on the portal:
Sex: an eligibility criteria based on biological characteristics. Information in the portal is based on available data and will default to 'all' when no other data is available.
Age: The age a person must be to participate in the clinical trial.
Accepts Healthy Volunteers: People who do not have the disease or condition can participate in the clinical trial.
Sex:
FEMALE
Accepts healthy volunteers:
Yes
Locations
Alberta
University of Alberta Hospital
Edmonton, Alberta, T6G 1Z1
Nova Scotia
Canadian Center for Vaccinology
Halifax, Nova Scotia, B3K 6R8
Ontario
Bluewater Clinical Research Group
Centricity Research - Toronto
Toronto, Ontario, M9W 4L6
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4
LMC Manna Research - Burlington - HyperCore - PPDS
Burlington, Ontario, L7M 4Y1
Quebec
Centricity Research - Mirabel - HyperCore - PPDS
Centricity Research - Montreal - HyperCore - PPDS
Pointe-Claire, Quebec, H9R 4S3
Centricity Research - Quebec - HyperCore - PPDS
Diex Recherche - Joilette - HyperCore - PPDS
Saint-Charles-Borromée, Quebec, J6E 2B4
Diex Recherche - Québec - HyperCore
Diex Recherche - Sherbrooke - HyperCore
Sherbrooke, Quebec, J1L 0H8
Diex Recherche - Victoriaville - HyperCore
Victoriaville, Quebec, G6P 6P6
McGill University Health Center
Montreal, Quebec, H4A 3J1
McGill University Health Centre-Vaccine Study Centre
Pierrefonds, Quebec, H9H 4Y6
