Respiratory Syncytial Virus (RSV)
Conditions
Keywords
RESPIRATORY SYNCYTIAL VIRUS (RSV), ADULTS AT HIGH RISK
Brief summary
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
BIOLOGICALRSVpreF
RSV Vaccine
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an open label study. Participant, investigators and other site staff, and sponsor staff will be unblinded to the participant's assigned study intervention.
Intervention model description
This is a single-arm, open-label study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants reporting prompted local reactions within 7 days following investigational product administration | Day 7 | Describe prompted local reactions following investigational product administration |
| Percentage of participants reporting prompted systemic events within 7 days following investigational product administration | Day 7 | Describe prompted systemic events following investigational product administration |
| Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration | 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 | 2 months after vaccination | Describe SAEs through 2 months following administration of investigational product |
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| GMT of NTs for RSV A and RSV B | 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. |
| Geometric mean fold rise (GMFR) of NTs for RSV A and RSV B | 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. |
| Seroresponse rate of NTs for RSV A and RSV B | 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 ≥4-fold rise from baseline if the baseline titer is ≥ LLOQ. |
Countries
Japan
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed