Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older
- Conditions
- Respiratory Syncytial Virus InfectionMetapneumovirus InfectionParainfluenzae Virus Infection
- Interventions
- Biological: RSV/hMPV vaccineBiological: RSV/hMPV/PIV3 vaccineBiological: parainfluenza virus type 3 vaccine (PIV3)Biological: RSV vaccine 1Biological: RSV vaccine 2
- Registration Number
- NCT06604767
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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 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.
- Detailed Description
The study duration will be up to approximately 12 months minus the screening period.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 390
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RSV/hMPV Formulation 2 RSV/hMPV vaccine Participants will receive a single intramuscular (IM) injection at Day 1 RSV/hMPV /PIV3 Formulation 1 RSV/hMPV/PIV3 vaccine Participants will receive a single intramuscular (IM) injection at Day 1 RSV/hMPV Formulation 1 RSV/hMPV vaccine Participants will receive a single intramuscular (IM) injection at Day 1 PIV3 Dose 1 parainfluenza virus type 3 vaccine (PIV3) Participants will receive a single intramuscular (IM) injection at Day 1 PIV3 Dose 3 parainfluenza virus type 3 vaccine (PIV3) Participants will receive a single intramuscular (IM) injection at Day 1 RSV vaccine 1 RSV vaccine 1 Participants will receive a single intramuscular (IM) injection at Day 1 PIV3 Dose 2 parainfluenza virus type 3 vaccine (PIV3) Participants will receive a single intramuscular (IM) injection at Day 1 PIV3 Dose 4 parainfluenza virus type 3 vaccine (PIV3) Participants will receive a single intramuscular (IM) injection at Day 1 RSV vaccine 2 RSV vaccine 2 Participants will receive a single intramuscular (IM) injection at Day 1
- Primary Outcome Measures
Name Time Method Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination 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 Within 7 days after vaccination Number of participants reporting:
- injection site reactions: pain, erythema and swellingPresence of solicited systemic reactions within 7 days after vaccination Within 7 days after vaccination Number of participants reporting:
* systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chillsPresence of unsolicited AEs within 28 days after vaccination Within 28 days after vaccination Number of participants experiencing unsolicited AEs
Presence of serious adverse events (SAEs) Within 6 months after vaccination Number of participants experiencing SAEs regardless of causality
Presence of adverse events of special interest (AESIs) Within 6 months after vaccination Number of participants experiencing AESIs regardless of causality
Presence of related SAEs throughout the study Throughout the study, approximately 12 months Number of participants experiencing related SAEs regardless of causality
Presence of related AESIs throughout the study Throughout the study, approximately 12 months Number of participants experiencing related AESIs regardless of causality
Presence of related fatal SAEs throughout the study 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) 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)
- Secondary Outcome Measures
Name Time Method 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 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 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 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 At Day 01 and Day 29 Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
Trial Locations
- Locations (8)
Investigational Site Number : 0360001
🇦🇺Botany, New South Wales, Australia
Investigational Site Number : 0360009
🇦🇺Brookvale, New South Wales, Australia
Investigational Site Number : 0360008
🇦🇺Herston, Queensland, Australia
Investigational Site Number : 0360006
🇦🇺Blacktown, New South Wales, Australia
Investigational Site Number : 0360005
🇦🇺Kanwal, New South Wales, Australia
Investigational Site Number : 0360004
🇦🇺Miranda, New South Wales, Australia
Investigational Site Number : 0360003
🇦🇺Bayswater, Victoria, Australia
Investigational Site Number : 0360002
🇦🇺Camberwell, Victoria, Australia