A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Older Adults in Korea

Phase 3

Recruiting

• Conditions: Respiratory Syncytial Virus
• Interventions: Biological: RSVpreF Vaccine; Other: Placebo

• Registration Number: NCT06593587
• Lead Sponsor: Pfizer

Brief Summary

The goal of this clinical trial is to quantify the immune response in older Korean adults after a RSVpreF vaccination. It will also learn about the safety and tolerability of RSVpreF vaccination. The main questions it aims to answer are:
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Detailed Description

This is a Phase 3, randomized, double-blinded, placebo-controlled, multicenter trial to describe the safety, tolerability, and immunogenicity of bivalent RSVpreF in adults 60 years of age and older in Korea.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Study Start: 2024-10-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Participants 60 years of age or older at Visit 1

   • Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration
   • Female participants must not be of childbearing potential

2. Healthy 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.

   Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.

3. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, frequent symptom assessment by mobile device application (e-diary), and other study procedures.

4. Participants who are ambulatory and live in the community, or in assisted-living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living (ADL).

5. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and the protocol.

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Exclusion Criteria

1. A confirmed diagnosis of RSV infection ≤180 days before study intervention administration.

2. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular (IM) injection.

3. Prior history of any subtype of Guillain-Barré syndrome (GBS) of any etiology.

4. 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.

5. 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.

6. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

7. Any medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

8. Individuals who receive chronic systemic treatment with immunosuppressive therapy (other than systemic corticosteroids meeting the criteria noted below), including cytotoxic agents, immunosuppressive monoclonal antibodies, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study.

   • Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for

     ≥14 days from 28 days before study intervention.

   • Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.

9. Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.

10. Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt throughout the study.

11. Previous administration with an investigational product (drug or vaccine) within 6 months prior to study intervention administration. Participation in other studies involving an investigational product (drug or vaccine) at any time during participation in this study.

12. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RSVpreF	RSVpreF Vaccine	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Local reactions (redness, swelling, and pain at the injection site)	7-days	In participants receiving the study intervention, the percentage of participants reporting local reactions within 7 days after vaccination
Systemic events (fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain)	7-days	In participants receiving the study intervention, the percentage of participants reporting systemic events within 7 days after vaccination
Adverse Events (AE)	1-month after vaccination	In participants receiving the study intervention, the percentage of participants reporting AEs within 1 month after vaccination
Serious Adverse Events (SAE)	2-months after vaccination	In participants receiving the study intervention, the percentage of participants reporting SAEs throughout the study
Newly diagnosed chronic medical conditions (NDCMC)	2-months after vaccination	In participants receiving the study intervention, the percentage of participants reporting NDCMC throughout the study
RSV A serum neutralizing titers (NTs)_GMT	1-month after vaccination	In participants in compliance with the key protocol criteria (evaluable immunogenicity population) geometric mean titer (GMT) of NTs for RSV A at each blood sampling visit
RSV B serum neutralizing titers (NTs)_GMT	1-month after vaccination	In participants in compliance with the key protocol criteria (evaluable immunogenicity population) geometric mean titer (GMT) of NTs for RSV B at each blood sampling visit
RSV A serum neutralizing titers (NTs)_GMFR	1-month after vaccination	In participants in compliance with the key protocol criteria (evaluable immunogenicity population) geometric mean fold rise (GMFR) of NTs for RSV A from before vaccination to 1 month after vaccination
RSV B serum neutralizing titers (NTs)_GMFR	1-month after vaccination	In participants in compliance with the key protocol criteria (evaluable immunogenicity population) geometric mean fold rise (GMFR) of NTs for RSV B from before vaccination to 1 month after vaccination

Secondary Outcome Measures

Name	Time	Method
RSV A serum neutralizing titers_Seroresponse rate	1-month after vaccination	Seroresponse rate of neutralizing titers for RSV A at 1 month after vaccination; Seroresponse is defined as a postvaccination NT ≥4 times the LLOQ if the baseline titer is below the LLOQ; or a ≥4-fold rise from baseline if the baseline titer is ≥ LLOQ.
RSV B serum neutralizing titers_Seroresponse rate	1-month after vaccination	Seroresponse rate of neutralizing titers for RSV B at 1 month after vaccination; Seroresponse is defined as a postvaccination NT ≥4 times the LLOQ if the baseline titer is below the LLOQ; or a ≥4-fold rise from baseline if the baseline titer is ≥ LLOQ.

Trial Locations

Locations (16)

The Catholic Univ. of Korea Seoul St. Mary's Hospital; 🇰🇷 Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Incheon-gwangyeoksi [incheon], Korea, Republic of

Jeonbuk National University Hospital; 🇰🇷 Jeonju-si, Jeonrabugdo, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju-si, Kwangju-kwangyǒkshi, Korea, Republic of

Korea University Ansan Hospital; 🇰🇷 Ansan-si, Kyǒnggi-do, Korea, Republic of

Soon Chun Hyang University Bucheon Hospital; 🇰🇷 Bucheon, Kyǒnggi-do, Korea, Republic of

The Catholic University Of Korea St. Vincent's Hospital; 🇰🇷 Suwon-si, Kyǒnggi-do, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Kyǒnggi-do, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Pusan-kwangyǒkshi, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

Hallym University Kangdong Sacred Heart Hospital; 🇰🇷 Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

Hallym University Kangnam Sacred Heart Hospital; 🇰🇷 Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Taegu-kwangyǒkshi, Korea, Republic of