Recruiting NCT07653100
A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RSVpreF, Placebo.
- Who it may be relevant to
- Registry conditions: Respiratory Syncytial Virus (RSV). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Biological RSVpreF
RSVpreF Vaccine - Biological Placebo
Placebo
Primary outcome measures
- Proportion of participants reporting local reactions within 7 days following investigational product administration [Time frame: Within 7 days]
- Percentage of participants reporting systemic events within 7 days following investigational product administration [Time frame: Within 7 days]
- Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration [Time frame: 1 month after vaccination]
- Percentage of participants reporting serious adverse events (SAEs) throughout the study [Time frame: 3 months after vaccination]
- 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]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
India · 13 centers
- King George Hospital — Visakhapatnam
- BGS Global Institute of Medical Sciences (BGSGIMS) — Bangalore
- Radhakrishna Multispeciality Hospital and IVF Center — Bangalore
- Belagavi Institute of Medical Sciences - Belagavi — Belagavi
- Suyog Hospital — Nashik
- Aakash Healthcare Private Limited — Dwarka
- All India Institute Of Medical Sciences — New Delhi
- Sir Ganga Ram Hospital — New Delhi
- … and 5 more centers
Identifiers
NCT: NCT07653100 · C3671040