A Study to Learn About ABRYSVO Vaccine in Older Adults to Prevent Severe Respiratory Syncytial Virus (RSV) Disease

NCT06077968 | Active Not Recruiting FDA Drug

• 2 other identifiers: C3671030NCT06077968
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to learn about the effectiveness of Pfizer's ABRYSVO vaccine. This vaccine helps to prevent infections caused by Respiratory Syncytial Virus (RSV). RSV is a virus that can cause infections in the airways. These symptoms can be cold-like symptoms, but in some cases can lead to severe symptoms or hospitalization. This study uses only healthcare data that are already collected from routine visits to healthcare providers. This means that participants will not be actively enrolled in the study and there are no study treatments. The study will look at data for about two years. This study will look at patient information from:

• Adults ages 60 years and older
• Adults who are eligible to receive the ABRYSVO vaccination Substudy A:
• This study will assess the duration of protection of ABRYSVO in adults ages 60 years and older after completion of the original study.
• The substudy will look at data from subsequent RSV seasons after the first dose of ABRYSVO for about 3 years. Substudy B:
• This study will assess vaccine effectiveness of ABRYSVO after revaccination in routine use, pending ACIP recommendation for revaccination.
• The substudy will look at data for about 2 years after revaccination.

Conditions

Respiratory Syncytial Viruses

Keywords

Lower respiratory tract infections; Acute respiratory infections; vaccine; RSV vaccine

Outcome Measures

Primary Outcomes (1)

• 1. Vaccine Effectiveness (VE) calculated as 1 minus the odds ratio (OR) comparing the odds of being vaccinated with ABRYSVO for RSV-related hospitalized LRTD cases and controls, multiplied by 100%.

  Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO against RSV-related LRTD hospitalizations

  Up to 2 years

Secondary Outcomes (32)

• Key Secondary 1: Among the immunocompetent, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related LRTD hospitalizations cases and controls, multiplied by 100%.

  Up to 2 years

• Key Secondary 2: ABRYSVO® VE estimates stratified by age group

  Up to 2 years

• Secondary 3: To further describe the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations stratified by RSV subgroup (A and B)

  Up to 2 years

• Secondary 4: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related severe LRTD cases and controls, multiplied by 100%

  Up to 2 years

• Secondary 5: ABRYSVO® VE estimates stratified by frailty index

  Up to 2 years

Study Arms (2)

Vaccinated

Patients will be considered vaccinated if they have documented evidence of receiving ABRYSVO ≥21 days before index date (i.e., defined as the date of hospitalization or Emergency Department (ED) admission.)

Biological: Prior standard of care receipt of Pfizer's ABRYSVO vaccine

Unvaccinated

Patients will be considered unvaccinated if they do not have documented evidence of receiving ABRYSVO.

Biological: Prior standard of care receipt of Pfizer's ABRYSVO vaccine

Interventions

Prior standard of care receipt of Pfizer's ABRYSVO vaccine BIOLOGICAL

Participants will receive Pfizer's ABRYSVO vaccine as part of standard of care. Vaccine is not administered in this study.

Unvaccinated; Vaccinated

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective database study using existing healthcare data, no patients will be actively enrolled. This study will be conducted at KPSC, an integrated health care organization comprising one of the largest health insurance plans in the United States (US), a hospital system, and \>7,800 physicians and 27,000 nurses located throughout 9 counties of Southern California. Approximately half of the KPSC network will be included in this study. For the TND, the study population will include all KPSC patients eligible for vaccination ages 60 and older per current ACIP recommendations who are admitted to the hospital or present to the ED with ARI or LRTD or cardiac events (exploratory objective) after study start, and who have had a respiratory specimen collected with an RSV test result, either through SOC testing or study testing of remnant SOC specimens.

You may qualify if:

• KPSC patients eligible to receive ABRYSVO® per current ACIP recommendations for adults ages 60 and older who are admitted to the hospital with ARI/LRTD, (defined using International Classification of Diseases (ICD) codes after start of study period, and who have had an RSV test, either through SOC testing or blinded study testing of remnant respiratory specimens.
• For secondary objectives estimating VE against ED admission, the TND will include KPSC patients eligible to receive ABRYSVO® who present to the ED with ARI/LRTD after start of study period, and who have had an RSV test, either through standard of care testing or blinded study testing of remnant respiratory specimens.
• For exploratory objectives estimating VE against RSV-related cardiac hospitalization, the TND will include KPSC patients eligible to receive ABRYSVO® who are hospitalized or present to the ED with cardiac events (defined using ICD codes) after start of study period, and who have had an RSV test, either through SOC testing or blinded study testing of remnant respiratory specimens.
• We will include membership requirement of 1 year prior to index date, which is defined as the date of hospitalization or ED admission (allowing 45-day administrative gap), to facilitate accurate capture of comorbid conditions.

You may not qualify if:

• Patients meeting any of the following criteria will not be included in the study:
• We will exclude patients who receive another licensed or investigational RSV vaccine prior to hospitalization or ED visit from the study population and analysis. Patients will be excluded if the index date is within certain time windows from vaccination date, outlined further in the exposure section below.
• SSA and SSB Eligibility Criteria:

Sponsors & Collaborators

• Kaiser Permanente: collaborator
• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Biospecimen

Retention: NONE RETAINED

Standard of care specimens will be salvaged and tested on a multiplex respiratory panel at a contracted vendor.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)