RSV/hMPV Vaccine for Respiratory Infections

Phase 1 & 2

Recruiting

Research Sponsored by Sanofi Pasteur, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential

Aged 60 years or older on the day of inclusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study (approximately 24 months)

Awards & highlights

Study Summary

This trial studies the safety & immunity of a single injection of an RSV & hMPV vaccine in adults over 60 & a booster 12 months later.

Who is the study for?

Adults aged 60 or older can join this vaccine study if they're not pregnant, breastfeeding, and don't have a history of severe allergies to the vaccine's ingredients. They should be generally healthy or have stable chronic diseases. People with recent serious infections, heart inflammation history, bleeding disorders, or on certain medications may not qualify.Check my eligibility

What is being tested?

The trial is testing different doses of an RSV/hMPV vaccine candidate in seniors to see how safe it is and how well it works (immunogenicity). Participants will get one shot and some will receive a booster after 12 months. A placebo group is included for comparison.See study design

What are the potential side effects?

Possible side effects are not detailed here but typically include reactions at the injection site like pain and swelling, general symptoms like fever or fatigue, allergic reactions, and other immune responses that could affect various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant, breastfeeding, and cannot become pregnant.

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I am 60 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study (approximately 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout study (approximately 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study (approximately 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Presence of adverse events of special interest (AESIs)

Presence of fatal SAEs

Presence of medically attended adverse events (MAAEs)

+9 more

Secondary outcome measures

RSV A serum anti-F IgG Ab titers at pre-booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination

RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination

RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination

+10 more

Trial Design

9Treatment groups

Experimental Treatment

Placebo Group

Group I: Sentinel Cohort: RSV/hMPV Group 2 (Dose B)Experimental Treatment1 Intervention