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Virus Therapy

RSVpreF Vaccine for Respiratory Syncytial Virus (Amélie Trial)

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

Healthy nonpregnant, nonbreastfeeding females 18 through 49 years of age at Visit 1 (Day 1)

Be between 18 and 65 years old

Must not have

Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration or planned receipt throughout the study

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the vaccines being administered in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 1 month after vaccination

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a vaccine called RSVpreF for Respiratory Syncytial Virus (RSV) to see how safe and effective it is. The vaccine comes in either a single-dose

Who is the study for?

Healthy nonpregnant, nonbreastfeeding female adults are eligible for this trial. It's designed to test a vaccine against Respiratory Syncytial Virus (RSV), which can cause serious airway diseases. Participants will visit the clinic twice and have one follow-up call.

What is being tested?

The study is testing RSVpreF, an RSV vaccine in two forms: one from a single-dose vial without preservatives and another from a multidose vial with 2-phenoxyethanol as a preservative to prevent bacterial growth.

What are the potential side effects?

Possible side effects of the RSVpreF vaccine may include typical reactions at the injection site like pain or swelling, general feelings of being unwell such as fatigue or headache, and potential mild allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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I am a healthy woman aged 18-49, not pregnant or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't received blood products or immunoglobulin in the last 60 days and don't plan to during the study.

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I have had severe allergic reactions to vaccines or their components.

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I have a weakened immune system as confirmed by my medical history or tests.

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I haven't taken immunosuppressants or had radiotherapy in the last 60 days.

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I have or had an autoimmune disease like lupus, MS, or type 1 diabetes.

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I have not received any RSV vaccine and do not plan to during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before vaccination, and 1 month after vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before vaccination, and 1 month after vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and before vaccination, and 1 month after vaccination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Immunogenicity - Geometric mean titer (GMT) ratio estimated by the ratio of the GMTs for RSV A and RSV B serum neutralizing titers (NTs) with RSVpreF in MDV participants to that in the RSVpreF SDV participants

The proportion of participants reporting adverse events

The proportion of participants reporting local reactions

+2 more

Secondary study objectives

Seroresponse rates by vaccine group