Evaluating safety and immune response of multiple vaccines in healthy adults aged 18 to 49.
A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different Formulations of Multivalent Influenza and Respiratory Syncytial Virus (RSV)/Human Metapneumovirus (hMPV)/Parainfluenza Virus Type 3 (PIV3) Vaccines in Healthy Participants 18 to 49 Years of Age.
This study is testing different flu and respiratory virus vaccines in healthy adults aged 18 to 49 to see how safe they are and how well they work.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 6 sites (Blacktown, New South Wales and 5 other locations) |
| Trial ID | NCT06850051 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and immunogenicity of various vaccine formulations targeting influenza and other respiratory viruses in healthy adults aged 18 to 49. Participants will receive a single intramuscular injection of one of the candidate vaccines, which include different doses of trivalent influenza vaccines and a combination vaccine for respiratory syncytial virus, human metapneumovirus, and parainfluenza virus. Throughout the study, participants will document any reactions or adverse events in a diary over a period of approximately six months.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 49 years.
Not a fit: Patients with medical conditions that may interfere with the evaluation of the study objectives will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved vaccine formulations that enhance protection against multiple respiratory viruses.
How similar studies have performed: Other studies have shown success with similar vaccine approaches, indicating potential for positive outcomes in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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 one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile OR * Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration. Exclusion Criteria: - Any medical condition or circumstance 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.
Where this trial is running
Blacktown, New South Wales and 5 other locations
- Paratus Clinical — Blacktown, New South Wales, Australia (Recruiting)
- Paratus Clinical — Herston, Queensland, Australia (Recruiting)
- University of Sunshine Coast Clinical Trials — Morayfield, Queensland, Australia (Recruiting)
- University of Sunshine Coast Clinical Trials — South Brisbane, Queensland, Australia (Recruiting)
- Griffith University — Southport, Queensland, Australia (Recruiting)
- Emeritus Research — Camberwell, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Sanofi Trial Transparency Email Recommended (Toll free for US
- Email: contact-us@sanofi.com
- Phone: 800-633-1610 ext Opt. 6
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.