A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF
ConditionRespiratory Syncytial Virus (RSV)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
The purpose of this phase 3 multicenter, double-blinded, placebo-controlled study in India is to learn about the safety and immunogenicity of RSVpreF in adults.
Eligibility criteria
Qualifiers
Participants ≥18 years of age at Visit 1.
Participants who are ambulatory and live independently in the community.
Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Chronic heart disease (ie, coronary artery disease, heart failure, or congenital heart disease)
Disqualifiers
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
Prior history of any subtype of Guillain-Barré syndrome of any etiology.
Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
Trial design
Treatments tested in this trial
- RSVpreF
- Placebo
Treatment groups
540 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov