Respiratory Syncytial Virus Immunization
Conditions
Keywords
RSV, RSV Infection, RSV Vaccine
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of different liponanaoparticle (LNP) formulations of modified ribonucleic acid (mRNA) vaccines using the RSV pre-F antigen in healthy participants 18 to 49 years of age. -Each participant will remain in the study for approximately 6 months. * The study intervention will be administered as a single intramuscular (IM) dose in the upper arm on Day 1 (D01). * The visit frequency will include 1 Screening Visit, 4 planned site visits to occur on D01, D03, D08, and D29, and 2 telephone calls to occur at Month (M)3 and M6.
Interventions
BIOLOGICALRSV vaccine formulation 1 dose
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV vaccine formulation 2 dose
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV vaccine formulation 3 dose
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV vaccine formulation 4 dose
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV vaccine formulation 5 dose
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV vaccine formulation 6 dose
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV vaccine formulation 7 dose
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV vaccine formulation 8 dose
Suspension for injection. Route of administration: IM injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Investigators, study site staff, laboratory personnel, outcome assessors, and participants will be blinded throughout the study. Study staff preparing and administering the study interventions will be unblinded throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 to 49 years on the day of inclusion * A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies: * Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR * Is of CBP (Child-Bearing Potential) and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
Exclusion criteria
* Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives * The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of any unsolicited systemic adverse events (aes) | Within 30 minutes after each vaccine injection | Number of participants experiencing immediate AEs |
| Presence of solicited injection site reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) | Through 7 days after each vaccine injection | Number of participants experiencing solicited injection site reactions |
| Presence of solicited systemic reactions (ie, pre-listed in the participant diary and in the CRF) | Through 7 days after each vaccine injection | Number of participants experiencing solicited systemic reactions |
| Presence of unsolicited AEs | Day 1 through day 29 | Number of participants experiencing unsolicited AEs |
| Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) | Throughout study, approximately 6 months | Number of participants experiencing SAEs and AESIs |
| Presence of out-of-range biological test results (including shift from baseline values) | Through 7 days after each vaccine injection | number of participants with out-of-range biological tests |
| RSV A nAb (Neutralizing Antibodies) titers | At day 1 and day 29 | — |
Countries
Australia
Outcome results
None listed