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

RETROSPECTIVE STUDY EVALUATING ABRYSVO® VACCINE EFFECTIVENESS AGAINST SEVERE LOWER RESPIRATORY TRACT DISEASE IN OLDER ADULTS

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 5 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Syncytial Viruses
• Intervention / Treatment: Biological: Prior standard of care receipt of Pfizer's ABRYSVO vaccine

Detailed Description

The overall research question asks how effective ABRYSVO® is against severe RSV disease in real-world populations. The primary objective of this study is to estimate the VE of Pfizer's ABRYSVO® vaccine against RSV-related LRTD hospitalizations among Kaiser Permanente Southern California members who are eligible for vaccination per Advisory Committee on Immunization Practices (ACIP) recommendations. Key secondary objectives include determining ABRYSVO® VE against RSV-related LRTD hospitalizations among the immunocompetent and stratified by age group (60-74 years vs 75 years and older). Additional secondary objectives include assessment of ABRYSVO® VE stratified by RSV subgroup, against ARI endpoints, death, among high-risk subgroups, and against critical outcomes.

A case control study with test negative design will be the primary analysis assessing RSV-related outcomes. An exploratory cohort design may also be used to assess all-cause outcomes and RSV-related outcomes.

Standard-of-care specimens (e.g. stored remnant respiratory specimens) from patients who did not receive RSV testing, who tested negative for RSV via RSV-only test, or a had limited multiplex viral respiratory panel assay will be salvaged and tested using a full respiratory multiplex polymerase chain reaction (PCR) panel at KPSC. Further, all RSV positives will be tested for RSV A and RSV B.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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 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.

Description

Inclusion Criteria:

1. KPSC patients eligible to receive ABRYSVO® per 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.
2. 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.
3. 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.
4. 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.

Exclusion Criteria:

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:

The inclusion criteria for Substudy A are described above for the Test Negative Design.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Participants will receive Pfizer's ABRYSVO vaccine as part of standard of care. Vaccine is not administered in this study.
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; Participants will receive Pfizer's ABRYSVO vaccine as part of standard of care. Vaccine is not administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
SSA Primary: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations during the 3rd RSV season after a single dose	Among those with 3 completed RSV seasons after vaccination with a single dose of ABRYSVO®, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized LRTD cases and controls, multiplied by 100%, using LRTD events from the 3rd season	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations among the immunocompetent.	Up to 2 years
Key Secondary 2: ABRYSVO® VE estimates stratified by age group	To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations stratified by age group (60-74 years vs 75 years and older)	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)	Adjusted for confounding factors using logistic regression. ABRYSVO® VE estimates stratified by virus subgroups	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%	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related severe LRTD.	Up to 2 years
Secondary 5: ABRYSVO® VE estimates stratified by frailty index	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalization stratified by frailty index.	Up to 2 years
Secondary 6: ABRYSVO® VE estimates stratified by chronic medical condition risk category	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations, stratified by chronic medical condition risk category (3 strata: not high-risk conditions, immunocompromising high-risk conditions, non-immunocompromising high-risk conditions).	Up to 2 years
Secondary 7: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized LRTD cases and controls, multiplied by 100%, among those with CHF or COPD	Adjusted for confounding factors using logistic regression. Among those with congestive heart failure (CHF) or Chronic Obstructive Pulmonary Disease (COPD,) to estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations	Up to 2 years
Secondary 8-1: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for ED (without subsequent hospitalization) cases and controls, multiplied by 100%	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against ED admission (without subsequent hospitalization)	Up to 2 years
Secondary 8-2: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for hospitalized or ED visit (without subsequent hospitalization) cases and controls, multiplied by 100%.	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against ED (without subsequent hospitalization) or hospitalization	Up to 2 years
Secondary 9: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related death cases and controls, multiplied by 100%.	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related death	Up to 2 years
Secondary 10-1: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for hospitalized RSV-related ARI cases and controls, multiplied by 100%	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related ARI hospitalization	Up to 2 years
Secondary 10-2: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related ARI ED visit (without subsequent hospitalization) cases and controls, multiplied by 100%	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related ARI ED visits (without subsequent hospitalization).	Up to 2 years
Secondary 12: ABRYSVO® RSV-related VE estimates stratified by age group and chronic medical risk categories	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations stratified by age group and chronic medical risk categories.	Up to 2 years
Secondary 13: ABRYSVO® VE estimates stratified by immunocompromised status	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations stratified by (1) immunocompromised vs immunocompetent, and separately (2) within those with immunocompromising condition, by severe vs moderate immunocompromised status.	2 years
Secondary 14: VE calculated as 1 minus the odds ratio (OR) comparing the odds of being vaccinated with ABRYSVO® for hMPV-related hospitalized ARI/LRTD cases and controls, multiplied by 100%	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against hMPV-related ARI/LRTD hospitalizations	2 years
Secondary 15: ABRYSVO® VE estimates stratified by age group.	Adjusted for confounding factors using logistic regression. To estimate ABRYSVO® VE against RSV-related LRTD hospitalizations by alternative age groups 60-69 years, 70-79 years, 80 years and older	2 years
Secondary 16: Among the immunocompetent, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visits 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 or ED visits (without subsequent hospitalization) among the immunocompetent.	2 years
Secondary 17: ABRYSVO® VE estimates stratified by age group	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED visits (without subsequent hospitalization), stratified by age group (60-74 years vs 75 years and older)	2 years
TND Secondary 10-3: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for ARI ED visit (without subsequent hospitalization) or ARI hospitalized RSV-related cases and controls, multiplied by 100%	Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related ARI hospitalization or ARI ED visits (without subsequent hospitalization)	2 years
TND Secondary 11: Describe age, sex, race/ethnicity, clinical and laboratory characteristics, and disease severity (LOS, ICU admission, respiratory support) of any patients who received ABRYSVO® and tested positive for RSV as compared to unvaccinated	To describe demographic, clinical, and laboratory characteristics and disease severity of any RSV events among vaccinated individuals as compared to unvaccinated	Up to 2 years
SSA Key Secondary 1: To estimate effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations in the 3rd season after a single dose overall and by time since vaccination up to 36 months	After the 3rd RSV season, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized LRTD cases and controls, overall and stratified by time since vaccination, multiplied by 100%, using LRTD hospitalization events from all seasons	Up to 3 years
SSA Secondary 2: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED visits (without subsequent hospitalization) during the 2nd RSV season after a single dose	Among those with 2 completed RSV seasons after vaccination with a single dose of ABRYSVO®, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%, using LRTD events from the 2nd season	Up to 2 years
SSA Secondary 3: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations during the 2nd RSV season after a single dose	Among those with 2 completed RSV seasons after vaccination with a single dose of ABRYSVO®, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized LRTD cases and controls, multiplied by 100%, using LRTD events from the 2nd season	Up to 2 years
SSA Secondary 4: To estimate effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED visits (without subsequent hospitalization) during the 3rd RSV season after a single dose	Among those with 3 completed RSV seasons after vaccination with a single dose of ABRYSVO®, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%, using LRTD events from the 3rd season	Up to 3 years
SSA Secondary 5: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED visits (without subsequent hospitalization) during the 4th RSV season after a single dose	Among those with 4 completed RSV seasons after vaccination with a single dose of ABRYSVO®, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%, using LRTD events from the 4th season	Up to 4 years
SSA Secondary 6: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations during the 4th RSV season after a single dose	Among those with 4 completed RSV seasons after vaccination with a single dose of ABRYSVO®, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized LRTD cases and controls, multiplied by 100%, using LRTD events from the 4th season	Up to 4 years
SSA Secondary 7: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED visits (without subsequent hospitalization) during the 5th RSV season after a single dose	Among those with 5 completed RSV seasons after vaccination with a single dose of ABRYSVO®, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%, using LRTD events from the 5th season	Up to 5 years
SSA Secondary 8: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations during the 5th RSV season after a single dose	Among those with 5 completed RSV seasons after vaccination with a single dose of ABRYSVO®, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized LRTD cases and controls, multiplied by 100%, using LRTD events from the 5th season	5 years
SSA Secondary 9: To estimate effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations/ED visits (without subsequent hospitalization) in the second season after a single dose overall and by time since vaccination, up to 24 months	After the 2nd RSV season, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, overall and stratified by time since vaccination, multiplied by 100%, using LRTD hospitalization/ED events from all seasons	2 years
SSA Secondary 10: To estimate effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations/ED visits (without subsequent hospitalization) in the third season after a single dose overall and by time since vaccination, up to 36 months	After the 3rd RSV season, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, overall and stratified by time since vaccination, multiplied by 100%, using LRTD hospitalization/ED events from all seasons	3 years
SSA Secondary 11: To estimate effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations/ED visits (without subsequent hospitalization) in the fourth season after a single dose overall and by time since vaccination, up to 48 months	After the 4th RSV season, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, overall and stratified by time since vaccination, multiplied by 100%, using LRTD hospitalization/ED events from all seasons	4 years
SSA Secondary 12: To estimate effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations/ED visits (without subsequent hospitalization) in the 5th season after a single dose overall and by time since vaccination, up to 60 months	After the 5th RSV season, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, overall and stratified by time since vaccination, multiplied by 100%, using LRTD hospitalization/ED events from all seasons	5 years
SSB Primary: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations after revaccination among those with 2 vs 0 dose of ABRYSVO®, in the first season after revaccination	VE calculated as 1 minus the OR comparing the odds of being vaccinated with two doses of ABRYSVO® vs not vaccinated with any dose of ABRYSVO® for RSV-related hospitalized LRTD cases and controls, multiplied by 100%, using events from the first season after the 2nd dose	1 year
SSB Secondary 1: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED events (without subsequent hospitalization) after revaccination among those with 2 vs 0 dose of ABRYSVO®, in the first season after revaccination	VE calculated as 1 minus the OR comparing the odds of being vaccinated with two doses of ABRYSVO® vs not vaccinated with any dose of ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%, using events from the first season after the 2nd dose	1 year
SSB Secondary 2: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations after revaccination among those with 2 vs 1 dose of ABRYSVO®, in the first season after revaccination	VE calculated as 1 minus the OR comparing the odds of being vaccinated with two doses of ABRYSVO® vs being vaccinated with one dose of ABRYSVO® for RSV-related hospitalized LRTD cases and controls, multiplied by 100%, using events from the first season after the 1st and 2nd dose	2 years
SSB Secondary 3: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED events (without subsequent hospitalization) after revaccination among those with 2 vs 1 dose of ABRYSVO®, in the first season after revaccination	VE calculated as 1 minus the OR comparing the odds of being vaccinated with two doses of ABRYSVO® vs being vaccinated with one dose of ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%, using events from the first season after the 1st and 2nd dose	2 years
SSB Secondary 4: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations after revaccination among those with 2 vs 0 dose of ABRYSVO®, in the second season after revaccination	VE calculated as 1 minus the OR comparing the odds of being vaccinated with two doses of ABRYSVO® vs not vaccinated with any dose of ABRYSVO® for RSV-related hospitalized LRTD cases and controls, multiplied by 100%, using events from the second season after the 2nd dose	2 years
SSB Secondary 5: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED events (without subsequent hospitalization) after revaccination among those with 2 vs 0 dose of ABRYSVO®, in the second season after revaccination	VE calculated as 1 minus the OR comparing the odds of being vaccinated with two doses of ABRYSVO® vs not vaccinated with any dose of ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%, using events from the second season after the 2nd dose	2 years
SSB Secondary 6: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations after revaccination among those with 2 vs 1 dose of ABRYSVO®, in the second season after revaccination	VE calculated as 1 minus the OR comparing the odds of being vaccinated with two doses of ABRYSVO® vs being vaccinated with one dose of ABRYSVO® for RSV-related hospitalized LRTD cases and controls, multiplied by 100%, using events from the second season after the 1st and 2nd dose	2 years
SSB Secondary 7: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED events (without subsequent hospitalization) after revaccination among those with 2 vs 1 dose of ABRYSVO®, in the second season after revaccination	VE calculated as 1 minus the OR comparing the odds of being vaccinated with two doses of ABRYSVO® vs being vaccinated with one dose of ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%, using events from the second season after the 1st and 2nd dose	2 years

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Kaiser Permanente
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: vaccine; Acute respiratory infections; Lower respiratory tract infections; RSV vaccine
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: C3671030; NCT06077968 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No