← Back to Search

Virus Therapy

RSVpreF single-dose vial (SDV) 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
1. Healthy nonpregnant, nonbreastfeeding females 18 through 49 years of age at Visit 1 (Day 1).
2. Willing and able to comply with all scheduled visits, investigational plan, lifestyle considerations, and other study procedures.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 1 month after vaccination
Awards & highlights

Summary

Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness, where medical help is needed. RSV can lead to airway diseases in all ages. Vaccines help your body make antibodies. These antibodies help fight against diseases. This is called an immune response. The purpose of this study is to learn about the safety, tolerability, and immunogenicity of a RSV vaccine called RSVpreF. RSVpreF comes either as: * a single dose in a container (called a vial), * or in a vial that holds multiple doses. A multidose vial contains more than one dose of RSVpreF. 2-Phenoxyethanol (2-PE) is a preservative to help prevent the growth of bacteria (germs). This study will compare RSVpreF with an added preservative called 2-phenoxyethanol (2-PE) from a multidose vial, to RSVpreF without an added preservative, from a single-dose vial. This study is looking to enroll nonpregnant, nonbreastfeeding, healthy female participants. Participants will need to visit the study clinic two times during the study. Participants will also have a final safety telephone call at the end of the study. All participants will receive a single shot of the study vaccine either from: * a multidose vial (with the preservative), or * from a single-dose vial (without the preservative) at the first study clinic visit. Blood samples will be taken at the two study clinic visits. Each participant will take part in the study for around 6 weeks.

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

Timeline

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: RSVpreF single-dose vial (SDV)Experimental Treatment1 Intervention
RSVpreF without 2-PE formulated in an SDV
Group II: RSVpreF multidose vial (MDV)Experimental Treatment1 Intervention
RSVpreF with 2-PE formulated in an MDV

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,623 Previous Clinical Trials
12,881,330 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
10,057,099 Total Patients Enrolled
~302 spots leftby Sep 2025