A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF

A PHASE 3 STUDY IN INDIA TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Syncytial Virus (RSV)
• Intervention / Treatment: Biological: Placebo; Biological: RSVpreF

• Study Type: Interventional
• Enrollment (Estimated): 540
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• India
  • Andhra Pradesh
    • Visakhapatnam, Andhra Pradesh, India, 530002
      • King George Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 560060
      • BGS Global Institute of Medical Sciences (BGSGIMS)
    • Bangalore, Karnataka, India, 560085
      • Radhakrishna Multispeciality Hospital and IVF Center
  • National Capital Territory of Delhi
    • Dwarka, National Capital Territory of Delhi, India, 110075
      • Aakash Healthcare Private Limited
  • Rajasthan
    • Jaipur, Rajasthan, India, 302039
      • Maharaja Agrasen Superspeciality Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• 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.
• Applicable to participants 18 through 59 years of age: Participants who are healthy or have stable preexisting diseases. These participants are considered at high risk of RSV disease by having at least 1 reportable stable chronic medical condition(s) that belongs to 1 or more of the following:
• Chronic heart disease (ie, coronary artery disease, heart failure, or congenital heart disease)
• Chronic lung disease (ie, COPD, emphysema, asthma, interstitial lung disease, or cystic fibrosis)
• Nongestational diabetes mellitus type 1 or type 2
• Severe obesity (body mass index [BMI] ≥40 kg/m2)
• Chronic liver disease (ie, cirrhosis)
• Chronic kidney disease (not including end-stage renal disease with or without dialysis)
• Chronic neurological disease that causes impaired airway clearance or respiratory muscle weakness (ie, poststroke dysphagia, amyotrophic lateral sclerosis, or muscular dystrophy)
• Chronic hematologic disease (ie, sickle cell disease or thalassemia)

Note: A chronic medical condition for this study is defined as:

• Duration ≥6 months.
• Requires regular medical follow-up or ongoing prescribed medication or hospitalization in the previous year.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.

Key Exclusion Criteria:

• 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.
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Placebo
Experimental: RSVpreF; RSVpreF Vaccine	Biological: RSVpreF; RSVpreF Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month after vaccination
Proportion of participants reporting local reactions within 7 days following investigational product administration	Describe local reactions following investigational product administration	Within 7 days
Percentage of participants reporting systemic events within 7 days following investigational product administration	Describe systemic events following investigational product administration	Within 7 days
Percentage of participants reporting serious adverse events (SAEs) throughout the study	Describe SAEs through 3 months following administration of investigational product	3 months after vaccination
Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT)		Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)		Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as seroresponse rate		1 month after vaccination

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): January 25, 2027

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: RSV, Vaccine
• Other Study ID Numbers: C3671040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes