A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF
ConditionRespiratory Syncytial Virus (RSV)
Trial statusRecruiting
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
RSVpreF
Biological/VaccineRSVpreF Vaccine
Placebo
Biological/VaccinePlacebo
Treatment groups
540 Participants
are divided into 2 treatment groupsGroup A: RSVpreFExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants reporting local reactions within 7 days following investigational product administration
Describe local reactions following investigational product administration
Time frame
Within 7 days2
Percentage of participants reporting systemic events within 7 days following investigational product administration
Describe systemic events following investigational product administration
Time frame
Within 7 days3
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
Describe AEs occurring through 1 month following administration of investigational product
Time frame
1 month after vaccination4
Percentage of participants reporting serious adverse events (SAEs) throughout the study
Describe SAEs through 3 months following administration of investigational product
Time frame
3 months after vaccination Source ClinicalTrials.gov