Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older
- 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 syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.
- Short title
- Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older
- Official title
- A Phase 1, Dose-Escalation, Randomized, Active-Controlled, Modified Double-Blind, Parallel-Group, Multi-Arm Study to Investigate the Safety and Immunogenicity of a Combined Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adult Participants Aged 60 Years and Older
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-03-24
- First posted
- 2024-09-19
- Registry last updated
- 2026-04-23
- Primary completion date
- 2026-03-24
- Start date
- 2024-09-17
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06604767
- ClinicalTrials.gov ID
- NCT06604767
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Triple masking
- Masking description
- -Investigators, Sponsor and study site staff, laboratory personnel, and participants will be blinded. Study staff preparing/administering the study interventions will be unblinded. Specific Sponsor personnel will be unblinded for the assessment of safety in the sentinel cohorts
- Masked roles
- Participants, Investigators, Outcome assessors
Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
Timeframe: Within 30 minutes after each vaccination
Number of participants experiencing immediate unsolicited systemic AEs
Presence of solicited administration site reactions within 7 days after vaccination
Timeframe: Within 7 days after vaccination
Number of participants reporting: \- injection site reactions: pain, erythema and swelling
Presence of solicited systemic reactions within 7 days after vaccination
Timeframe: Within 7 days after vaccination
Number of participants reporting: * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Presence of unsolicited AEs within 28 days after vaccination
Timeframe: Within 28 days after vaccination
Number of participants experiencing unsolicited AEs
Presence of serious adverse events (SAEs)
Timeframe: Within 6 months after vaccination
Number of participants experiencing SAEs regardless of causality
Presence of adverse events of special interest (AESIs)
Timeframe: Within 6 months after vaccination
Number of participants experiencing AESIs regardless of causality
Presence of related SAEs throughout the study
Timeframe: Throughout the study, approximately 12 months
Number of participants experiencing related SAEs regardless of causality
Presence of related AESIs throughout the study
Timeframe: Throughout the study, approximately 12 months
Number of participants experiencing related AESIs regardless of causality
Presence of related fatal SAEs throughout the study
Timeframe: Throughout the study, approximately 12 months
Number of participants experiencing related fatal SAEs regardless of causality
Presence of out-of-range biological test results (including shift from baseline values)
Timeframe: Within 7 days after vaccination
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
RSV A serum neutralizing antibody (nAb) titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
Timeframe: At Day 01 and Day 29
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
Timeframe: At Day 01 and Day 29
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines
Timeframe: At Day 01 and Day 29
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines
Timeframe: At Day 01 and Day 29
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 60 Years
- Healthy volunteers
- Yes
- 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.
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.
- Investigational Site Number : 0360006Blacktown, Australia
- Investigational Site Number : 0360001Botany, Australia
- Investigational Site Number : 0360009Brookvale, Australia
- Investigational Site Number : 0360005Kanwal, Australia
- Investigational Site Number : 0360004Miranda, Australia
- Investigational Site Number : 0360008Herston, Australia
- Investigational Site Number : 0360003Bayswater, Australia
- Investigational Site Number : 0360002Camberwell, Australia
Other registry identifiers
- U1111-1304-9362