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NCT Number: NCT07543380

A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.

The purpose of the study is to learn about the immune response after a RSVpreF vaccination. This study is being conducted in Japan. RSV is a common virus that can cause infections of the lungs and airways.

The study is seeking participants who are:

* 18 to 59 years of age * adults with health condition(s) that can put them at an increased risk of severe RSV disease

It will also learn about the safety of RSVpreF vaccination. The study lasts about 2 months. Adults need to visit the research site at least 2 times. The participant will receive a phone call 2 months after vaccination for health checks.

Recruiting

Interested in participating?

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tsuchiura Beryl Clinic, Tsuchiura, Ibaraki, Japan

Loading trial locations.

About this study

This is a Phase 3, multicenter, single-arm, open-label study that will assess the safety, tolerability, and immunogenicity of Pfizer's RSVpreF in adults 18 to 59 years of age considered to be at high risk of RSV disease due to certain chronic medical conditions in Japan.

Approximately 130 participants 18 to 59 years of age considered at high risk of RSV disease due to certain chronic medical conditions will be enrolled to receive RSVpreF.

The total duration of trial participation for each participant will be 2 months.

After screening and confirmation of eligibility, a prevaccination blood sample will be collected for immunogenicity assessments and a single dose of study intervention (RSVpreF) will be administered.

Participants will report daily reactogenicity data using an electronic device for 7-days or until resolution.

Participants will return approximately 1 month later for a follow-up blood draw for immunogenicity assessments and collection of safety information.

A telephone follow-up visit will be conducted approximately 2 months after vaccination to collect safety information.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Underlying health condition(s) that can put the participant at an increased risk of severe RSV/complications including chronic lung , heart, kidney, liver, nervous system, blood, or metabolic diseases

Key Exclusion Criteria:

  • Received any kind of RSV vaccine before participating in this study
  • Determined as not eligible by the investigator based on the participant's past and present health condition(s), medication(s) and treatment(s)

Please refer to the study contact for further eligibility details.

Treatment and study plan

RSVpreF

Biological

RSV Vaccine

Primary outcomes

  1. Percentage of participants reporting prompted local reactions within 7 days following investigational product administration

    Time frame: Day 7

    Describe prompted local reactions following investigational product administration

  2. Percentage of participants reporting prompted systemic events within 7 days following investigational product administration

    Time frame: Day 7

    Describe prompted systemic events following investigational product administration

  3. 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

  4. Percentage of participants reporting serious adverse events (SAEs) throughout the study

    Time frame: 2 months after vaccination

    Describe SAEs through 2 months following administration of investigational product

  5. Geometric Mean Titer (GMT) ratio (GMR) , estimated by the ratio of the GMTs for RSV subgroup A (RSV A) and RSV subgroup B (RSV B) neutralizing titers (NTs) with RSVpreF in this study's participants to that in Study C3671013 Japanese older adults

    Time frame: 1 month after vaccination

    Demonstrate that the immune responses to RSVpreF in this study participant are similar to those in Study C3671013 Japanese older adults

Secondary outcomes

  1. GMT of NTs for RSV A and RSV B

    Time frame: 1 month after vaccination

    Describe the immune responses to RSVpreF with GMT of NTs for RSV A and RSV B before vaccination and at 1 month after vaccination.

  2. Geometric mean fold rise (GMFR) of NTs for RSV A and RSV B

    Time frame: 1 month after vaccination

    Describe the immune responses to RSVpreF with GMFR of NTs for RSV A and RSV B from before vaccination to 1 month after vaccination.

  3. Seroresponse rate of NTs for RSV A and RSV B

    Time frame: 1 month after vaccination

    Describe the immune responses to RSVpreF with seroresponse rate of NTs for RSV A and RSV B at 1 month after vaccination.

    Seroresponse is defined as a postvaccination NT ≥4 times the lower limit of quantitation (LLOQ) if the baseline titer is below the LLOQ; or a ≥

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 3, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS CONSIDERED AT HIGH RISK OF SEVERE RSV DISEASE IN JAPAN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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