Respiratory Syncytial Virus (RSV)Phase 3NCT07653100
A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF
A Phase 3 study testing RSVpreF in people with Respiratory Syncytial Virus (RSV), run by Pfizer at 13 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- RSVpreF
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 13 sitesIndia
- Study dates
- 22 Jun 2026to 25 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
India13 sites, 13 recruiting
- Recruiting
BGS Global Institute of Medical Sciences (BGSGIMS)
Bangalore, Karnataka, 560060
- Recruiting
Radhakrishna Multispeciality Hospital and IVF Center
Bangalore, Karnataka, 560085
- Recruiting
Belagavi Institute of Medical Sciences - Belagavi
Belagavi, Karnataka, 590001
- Recruiting
SRM Medical College Hospital and Research Centre - Kattankulathur
Chengalpattu, Tamil Nadu, 603203
- Recruiting
Aakash Healthcare Private Limited
Dwarka, National Capital Territory of Delhi, 110075
- Recruiting
Maharaja Agrasen Superspeciality Hospital
Jaipur, Rajasthan, 302039
- Recruiting
Chettinad Hospital and Research Institute
Kelambākkam, Tamil Nadu, 603103
- Recruiting
Institute of Post Graduate Medical Education & Research, SSKM Hospital
Kolkata, West Bengal, 700020
- Recruiting
Suyog Hospital
Nashik, Maharashtra, 422003
- Recruiting
All India Institute Of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
- Recruiting
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
- Recruiting
Bharati Vidyapeeth {Deemed to be University) Medical College Hospital & Research Centre
Pune, Maharashtra, 411043
- Recruiting
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002
About this study
Official title: 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.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- RSVpreF, Placebo
- Keywords
- RSV, Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSVpreFBiological
RSVpreF Vaccine
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| RSVpreF | Experimental | RSVpreF Vaccine Receives: Biological: RSVpreF |
| Placebo | Placebo comparator | Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants reporting local reactions within 7 days following investigational product administration
Describe local reactions following investigational product administration
Measured: Within 7 days
Percentage of participants reporting systemic events within 7 days following investigational product administration
Describe systemic events following investigational product administration
Measured: 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
Measured: 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
Measured: 3 months after vaccination
Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
Measured: Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
Measured: Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as seroresponse rate
Measured: 1 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start22 Jun 2026
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653100
- Sponsor's protocol ID
- C3671040
- Status last verified
- Sep 2026
- First submitted
- 11 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 3 STUDY IN INDIA TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS
- ClinicalTrials.gov ID
- NCT07653100
- Acronym / sponsor ID
- C3671040
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- RSV, Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSVpreF | Experimental | Biological: RSVpreFRSVpreF Vaccine |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSVpreFRSVpreF Vaccine | Biological | RSVpreF |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Proportion of participants reporting local reactions within 7 days following investigational product administration
Time frame: Within 7 days
Describe local reactions following investigational product administration
Percentage of participants reporting systemic events within 7 days following investigational product administration
Time frame: Within 7 days
Describe systemic events following investigational product administration
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
Time frame: 1 month after vaccination
Describe AEs occurring through 1 month following administration of investigational product
Percentage of participants reporting serious adverse events (SAEs) throughout the study
Time frame: 3 months after vaccination
Describe SAEs through 3 months following administration of investigational product
Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
Time frame: Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
Time frame: Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as seroresponse rate
Time frame: 1 month after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RSVpreF in people with Respiratory Syncytial Virus (RSV), run by Pfizer at 13 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants reporting local reactions within 7 days following investigational product administration (time frame: Within 7 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.