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

NCT07653100 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: C3671040
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

RSV, Vaccine

Outcome Measures

Primary Outcomes (7)

• 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 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

• 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

Study Arms (2)

RSVpreF

EXPERIMENTAL

RSVpreF Vaccine

Biological: RSVpreF

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

RSVpreF BIOLOGICAL

RSVpreF Vaccine

RSVpreF

Placebo BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants ≥18 years of age at Visit 1.
• Participants who are ambulatory and live independently in the community.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (13)

King George Hospital

Visakhapatnam, Andhra Pradesh, 530002, India

NOT YET RECRUITING

BGS Global Institute of Medical Sciences (BGSGIMS)

Bangalore, Karnataka, 560060, India

RECRUITING

Radhakrishna Multispeciality Hospital and IVF Center

Bangalore, Karnataka, 560085, India

RECRUITING

Belagavi Institute of Medical Sciences - Belagavi

Belagavi, Karnataka, 590001, India

RECRUITING

Suyog Hospital

Nashik, Maharashtra, 422003, India

RECRUITING

Aakash Healthcare Private Limited

Dwarka, National Capital Territory of Delhi, 110075, India

RECRUITING

All India Institute Of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

RECRUITING

Maharaja Agrasen Superspeciality Hospital

Jaipur, Rajasthan, 302039, India

RECRUITING

SRM Medical College Hospital and Research Centre - Kattankulathur

Chengalpattu, Tamil Nadu, 603203, India

RECRUITING

Chettinad Hospital and Research Institute

Kelambākkam, Tamil Nadu, 603103, India

RECRUITING

Institute of Post Graduate Medical Education & Research, SSKM Hospital

Kolkata, West Bengal, 700020, India

NOT YET RECRUITING

Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

Kolkata, West Bengal, 700020, India

NOT YET RECRUITING

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded, placebo-controlled.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): January 25, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

IN (13)