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Recruiting NCT07543380

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

Phase III Interventional Respiratory Syncytial Virus (RSV)

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.
Who it may be relevant to
Registry conditions: Respiratory Syncytial Virus (RSV). Basic parameters: 18 years — 59 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
Japan
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, 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

Overview

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.

Detailed description

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.

Interventions

  • Biological RSVpreF
    RSV Vaccine

Primary outcome measures

  • Percentage of participants reporting prompted local reactions within 7 days following investigational product administration [Time frame: Day 7]
  • Percentage of participants reporting prompted systemic events within 7 days following investigational product administration [Time frame: Day 7]
  • 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: 2 months after vaccination]
  • 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]
Secondary outcome measures (3)
  • GMT of NTs for RSV A and RSV B [Time frame: 1 month after vaccination]
  • Geometric mean fold rise (GMFR) of NTs for RSV A and RSV B [Time frame: 1 month after vaccination]
  • Seroresponse rate of NTs for RSV A and RSV B [Time frame: 1 month after vaccination]

Eligibility criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Japan · 5 centers
  • Tsuchiura Beryl Clinic — Tsuchiura
  • Nihonbashi Sakura Clinic — Chuo-ku
  • Tokyo-Eki Center-building Clinic — Chuo-ku
  • Fukuwa Clinic — Chuo-ku
  • Tenjin Sogo Clinic — Fukuoka

Identifiers

NCT: NCT07543380 · C3671060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗