Status:
ACTIVE_NOT_RECRUITING
Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Respiratory Syncytial Virus Infection
Metapneumovirus Infection
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytia...
Detailed Description
The study duration will be up to approximately 12 months minus the screening period.
Eligibility Criteria
Inclusion
- Aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday).
- Informed consent form (ICF) has been signed and dated
- A female participant is eligible to participate if she is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.
Exclusion
- Participants are excluded from the study if any of the following criteria apply:
- Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2026
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT06604767
Start Date
September 17 2024
End Date
March 5 2026
Last Update
April 4 2025
Active Locations (8)
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1
Investigational Site Number : 0360006
Blacktown, New South Wales, Australia, 2148
2
Investigational Site Number : 0360001
Botany, New South Wales, Australia, 2019
3
Investigational Site Number : 0360009
Brookvale, New South Wales, Australia, 2100
4
Investigational Site Number : 0360005
Kanwal, New South Wales, Australia, 2259