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Respiratory Syncytial VirusesNCT06077968

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

An observational study of Respiratory Syncytial Viruses, run by Pfizer at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Respiratory Syncytial Viruses
Type of treatment
Vaccines
How many people
1 participants
Where
1 siteUnited States
Study dates
1 Nov 2023to 1 May 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pfizer

    New York, New York, 10001

Other trials in United States

About this study

Official title: 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:

Read more
  • 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.
Read the 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.

Being tested
Prior standard of care receipt of Pfizer's ABRYSVO vaccine
Keywords
Lower respiratory tract infections, Acute respiratory infections, vaccine, RSV vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prior standard of care receipt of Pfizer's ABRYSVO vaccineBiological

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

Study groups in NCT06077968
Study groupRoleWhat they receive
VaccinatedPatients 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.)
Receives: Biological: Prior standard of care receipt of Pfizer's ABRYSVO vaccine
UnvaccinatedPatients will be considered unvaccinated if they do not have documented evidence of receiving ABRYSVO.
Receives: Biological: Prior standard of care receipt of Pfizer's ABRYSVO vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 2 years

  2. 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

    Measured: Up to 3 years

Secondary outcomes (40)

  1. 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.

    Measured: Up to 2 years

  2. 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)

    Measured: Up to 2 years

  3. 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

    Measured: Up to 2 years

  4. 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.

    Measured: Up to 2 years

  5. 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.

    Measured: Up to 2 years

  6. 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).

    Measured: Up to 2 years

  7. 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

    Measured: Up to 2 years

  8. 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)

    Measured: Up to 2 years

  9. 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

    Measured: Up to 2 years

  10. 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

    Measured: Up to 2 years

  11. 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

    Measured: Up to 2 years

  12. 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).

    Measured: Up to 2 years

  13. 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)

    Measured: 2 years

  14. 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

    Measured: Up to 2 years

  15. 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.

    Measured: Up to 2 years

  16. 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.

    Measured: 2 years

  17. 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

    Measured: 2 years

  18. 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

    Measured: 2 years

  19. 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.

    Measured: 2 years

  20. 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)

    Measured: 2 years

  21. 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

    Measured: Up to 3 years

  22. 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

    Measured: Up to 2 years

  23. 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

    Measured: Up to 2 years

  24. 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

    Measured: Up to 3 years

  25. 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

    Measured: Up to 4 years

  26. 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

    Measured: Up to 4 years

  27. 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

    Measured: Up to 5 years

  28. 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

    Measured: 5 years

  29. 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

    Measured: 2 years

  30. 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

    Measured: 3 years

  31. 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

    Measured: 4 years

  32. 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

    Measured: 5 years

  33. 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

    Measured: 1 year

  34. 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

    Measured: 1 year

  35. 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

    Measured: 2 years

  36. 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

    Measured: 2 years

  37. 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

    Measured: 2 years

  38. 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

    Measured: 2 years

  39. 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

    Measured: 2 years

  40. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2023
  2. Study start1 Nov 2023
  3. Primary completion1 May 2029 (estimated)
  4. Study completion1 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06077968
Sponsor's protocol ID
C3671030
Other IDs
NCT06077968
Status last verified
May 2026
First submitted
5 Oct 2023
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Tartof SY, Zasowski EJ, Aliabadi N, Goodwin G, Slezak J, Hong V, Frankland TB, Ackerson B, Liu Q, Shaw S, Welsh S, Kapadia B, Spence BC, Davis GS, Lewnard JA, Chowdhry H, Dutro M, Chilson E, Cane A, Hayford K, Begier E. Bivalent RSVpreF Effectiveness Against Respiratory Syncytial Virus (RSV)-Related Respiratory Disease Hospitalization and Emergency Department Visits Across Three RSV Seasons. Infect Dis Ther. 2026 Sep 18. doi: 10.1007/s40121-026-01438-w. Online ahead of print.

    PubMed 42758281

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Syncytial Viruses, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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%. (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06077968, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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