Respiratory Syncytial Virus (RSV)STREETONNCT07122661
STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia (STREETON)
An observational study of Respiratory Syncytial Virus (RSV) and Respiratory Syncytial Virus, run by Pfizer at 1 site in Australia.
Trial summary
This Pfizer-sponsored real-world retrospective non-interventional study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care clinical encounters available in health records, supplemented with information from the official… Read more about this study
- Who is it for?
- Ages 0 years to 12 months
- Conditions the study is for
- Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus, Lower Respiratory Tract Disease
- What is being tested?
- ABRYSVO
- Type of treatment
- Vaccines
- How many people
- 1 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Aug 2025to 30 Apr 2027
- 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 0 years to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: This hospital-based retrospective study will be conducted in up to 9 hospitals across 6 states/territories in Australia, supported by the Paediatric Active Enhanced Diseases Surveillance Network. Given the retrospective nature of this study, hospitals that already function as national sentinel units for respiratory virus surveillance, or have robust clinical, laboratory or epidemiological surveillance will be included. Each participating hospital conducts year-round standard of care testing for acute respiratory illness which includes respiratory virus panel test using PCR. Study will include all infants through 12 months of age who were admitted to one of the participating hospitals with symptoms of respiratory infection, met the clinical case definition of acute respiratory illness, and had a respiratory specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission with an RSV test result through standard of care testing.
Who may be able to join
- Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Infant ≤12 months (≤360 days) of age on the hospitalisation date.
- Index date within the time period for data collection (approximately 01 March 2025 - 28 February 2027)
- Hospitalised with acute respiratory illness meeting the protocol-defined clinical case definition, and for whom RSV testing results from a specimen collected 10 days prior to hospital admission through 3 days after a hospital admission are known.
- Infant born to a birth mother eligible to receive ABRYSVO vaccination, with infant date of birth on or after 17 February 2025.
Who cannot join
- Participants meeting any of the following criteria will not be included in the study:
- Infant born at <28 weeks and 0/7 days of gestational age.
- Infant received any licensed or investigational RSV preventive product (e.g., palivizumab, nirsevimab, active RSV vaccine) since birth.
- Infant received ≥1 blood transfusion or other blood products containing antibody (e.g., fresh frozen plasma) since birth.
- Infant born to a birth mother who received any other licensed or investigational RSV vaccine during this pregnancy.
- Infant born to a birth mother for whom ABRYSVO vaccination status cannot be confirmed in available data sources.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia
This Pfizer-sponsored real-world retrospective non-interventional study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care clinical encounters available in health records, supplemented with information from the official national immunisation registry, the Australian Immunisation Register. Additional data from accredited pathology laboratories will be included. There will be no active enrollment of study participants, no direct contact with study participants, and no collection of any primary data outside of the standard of care.
This study will use a test negative design to evaluate real-world vaccine effectiveness of RSVpreF vaccination during pregnancy against RSV-associated outcomes in infants.
Read the detailed description
This case-control study using a test negative design will include all infants through 12 months of age who were admitted to one of the participating hospitals with symptoms of respiratory infection, met the clinical case definition of acute respiratory illness, and had a respiratory specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission with an RSV test result through standard of care testing.
The primary objective is to estimate vaccine effectiveness (VE) of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease (LRTD) hospitalisation among infants from birth through 6 months (0 to ≤180 days) of age.
Baseline characteristics of the study population will be described by case/control status and by maternal RSVpreF vaccination status. Standardised mean differences may be used to compare the distributions (absolute differences >0.10 will be considered meaningful). For all VE objectives, we will use a logistic regression model to compare the odds of maternal ABRYSVO vaccination during pregnancy between test-positive cases and test-negative controls, generating an odds ratio (OR) and 95% CI and we will use multivariable logistic regression to compute an adjusted OR (aOR), from which we will derive final VE estimates, adjusted for potential confounding, according to the formula: VE = (1-aOR) x 100%.
- Conditions
- Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus, Lower Respiratory Tract Disease, Respiratory Tract Diseases, Acute Respiratory Illness (ARI)
- Being tested
- ABRYSVO
- Keywords
- RSVpreF, Vaccine, Effectiveness, Vaccine Effectiveness, Pregnancy, Maternal, Immunization, Maternal Immunization, ABRYSVO, Respiratory Syncytial Virus, Lower Respiratory Tract Disease, Infants, Hospitalized, Hospitalization, Test Negative Design, Case Control, Retrospective, Respiratory Outcomes, Prefusion F protein-based, Acute Respiratory Illness
- Medical subject headings
- Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABRYSVOBiological
Also called RSVpreF, RSV Prefusion F
This is a non-interventional retrospective study; therefore, ABRYSVO vaccine has already been administered according to the standard of care. ABRYSVO is a bivalent RSV prefusion F protein-based vaccine (RSVpreF) composed of two prefusion F proteins to protect against both RSV-A and RSV-B.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Infants who meet the respiratory clinical case definition and test positive for RSV (result obtained from standard of care testing with specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission). Receives: Biological: ABRYSVO | |
| Controls | Infants who meet the respiratory clinical case definition and test negative for RSV (result obtained from standard of care testing with specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission). Receives: Biological: ABRYSVO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease hospitalisation among infants.
RSV-positive lower respiratory tract disease hospitalisation occurring 0 to ≤180 days after birth.
Measured: From birth through 6 months (0 to ≤180 days) of age.
Secondary outcomes (3)
Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease hospitalisation among infants.
RSV-positive lower respiratory tract disease hospitalisation occurring 0 to ≤180 days after birth subgrouped by:
- gestational age at ABRYSVO vaccination.
- gestational age at birth.
- time from ABRYSVO vaccination to birth.
- time intervals of infant age at illness, including cumulative (e.g., 0 to ≤3 months, 0 to ≤6 months) and discrete (e.g., 0 to ≤3 months, >3 to ≤6 months) age intervals.
Measured: From birth through 6 months (0 to ≤180 days) of age within key subgroups.
Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive severe lower respiratory tract disease hospitalisation among infants.
RSV-positive lower respiratory tract disease hospitalisation occurring 0 to ≤180 days after birth subgrouped by:
- gestational age at ABRYSVO vaccination.
- gestational age at birth.
- time from ABRYSVO vaccination to birth.
- time intervals of infant age at illness, including cumulative (e.g., 0 to ≤3 months, 0 to ≤6 months) and discrete (e.g., 0 to ≤3 months, >3 to ≤6 months) age intervals.
Measured: From birth through 6 months (0 to ≤180 days) of age and within key subgroups.
Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive acute respiratory illness hospitalisation among infants.
RSV-positive acute respiratory illness hospitalisation occurring 0 to ≤180 days after birth subgrouped by:
- gestational age at ABRYSVO vaccination.
- gestational age at birth.
- time from ABRYSVO vaccination to birth.
- time intervals of infant age at illness, including cumulative (e.g., 0 to ≤3 months, 0 to ≤6 months) and discrete (e.g., 0 to ≤3 months, >3 to ≤6 months) age intervals.
Measured: From birth through 6 months (0 to ≤180 days) of age and within key subgroups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start11 Aug 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Kids Research Institute Australia on behalf of the Centre for Child Health Research, University of Western Australia
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122661
- Sponsor's protocol ID
- C3671066
- Acronym
- STREETON
- Status last verified
- Nov 2025
- First submitted
- 7 Aug 2025
- Last updated
- 19 Nov 2025
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia
- ClinicalTrials.gov ID
- NCT07122661
- Acronym / sponsor ID
- STREETON / C3671066
- Conditions
- Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus, Lower Respiratory Tract Disease, Respiratory Tract Diseases, Acute Respiratory Illness (ARI)
- Keywords
- RSVpreF, Vaccine, Effectiveness, Vaccine Effectiveness, Pregnancy, Maternal, Immunization, Maternal Immunization
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- The Kids Research Institute Australia on behalf of the Centre for Child Health Research, University of Western Australia
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Pfizer-sponsored real-world retrospective non-interventional study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care clinical encounters available in health records, supplemented with information from the official national immunisation registry, the Australian Immunisation Register. Additional data from accredited pathology laboratories will be included. There will be no active enrollment of study participants, no direct contact with study participants, and no collection of any primary data outside of the standard of care.
This study will use a test negative design to evaluate real-world vaccine effectiveness of RSVpreF vaccination during pregnancy against RSV-associated outcomes in infants.
Detailed description
This case-control study using a test negative design will include all infants through 12 months of age who were admitted to one of the participating hospitals with symptoms of respiratory infection, met the clinical case definition of acute respiratory illness, and had a respiratory specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission with an RSV test result through standard of care testing.
The primary objective is to estimate vaccine effectiveness (VE) of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease (LRTD) hospitalisation among infants from birth through 6 months (0 to ≤180 days) of age.
Baseline characteristics of the study population will be described by case/control status and by maternal RSVpreF vaccination status. Standardised mean differences may be used to compare the distributions (absolute differences >0.10 will be considered meaningful). For all VE objectives, we will use a logistic regression model to compare the odds of maternal ABRYSVO vaccination during pregnancy between test-positive cases and test-negative controls, generating an odds ratio (OR) and 95% CI and we will use multivariable logistic regression to compute an adjusted OR (aOR), from which we will derive final VE estimates, adjusted for potential confounding, according to the formula: VE = (1-aOR) x 100%.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Biological: ABRYSVOInfants who meet the respiratory clinical case definition and test positive for RSV (result obtained from standard of care testing with specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission). |
| Controls | – | Biological: ABRYSVOInfants who meet the respiratory clinical case definition and test negative for RSV (result obtained from standard of care testing with specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission). |
Who may qualify
- Ages
- 0 years to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This hospital-based retrospective study will be conducted in up to 9 hospitals across 6 states/territories in Australia, supported by the Paediatric Active Enhanced Diseases Surveillance Network. Given the retrospective nature of this study, hospitals that already function as national sentinel units for respiratory virus surveillance, or have robust clinical, laboratory or epidemiological surveillance will be included. Each participating hospital conducts year-round standard of care testing for acute respiratory illness which includes respiratory virus panel test using PCR. Study will include all infants through 12 months of age who were admitted to one of the participating hospitals with symptoms of respiratory infection, met the clinical case definition of acute respiratory illness, and had a respiratory specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission with an RSV test result through standard of care testing.
Key inclusion criteria (5 listed)
- Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Infant ≤12 months (≤360 days) of age on the hospitalisation date.
- Index date within the time period for data collection (approximately 01 March 2025 - 28 February 2027)
- Hospitalised with acute respiratory illness meeting the protocol-defined clinical case definition, and for whom RSV testing results from a specimen collected 10 days prior to hospital admission through 3 days after a hospital admission are known.
- Infant born to a birth mother eligible to receive ABRYSVO vaccination, with infant date of birth on or after 17 February 2025.
Key exclusion criteria (6 listed)
- Infant born at <28 weeks and 0/7 days of gestational age.
- Infant received any licensed or investigational RSV preventive product (e.g., palivizumab, nirsevimab, active RSV vaccine) since birth.
- Infant received ≥1 blood transfusion or other blood products containing antibody (e.g., fresh frozen plasma) since birth.
- Infant born to a birth mother who received any other licensed or investigational RSV vaccine during this pregnancy.
- Infant born to a birth mother for whom ABRYSVO vaccination status cannot be confirmed in available data sources.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABRYSVOAlso: RSVpreF, RSV Prefusion FThis is a non-interventional retrospective study; therefore, ABRYSVO vaccine has already been administered according to the standard of care. ABRYSVO is a bivalent RSV prefusion F protein-based vaccine (RSVpreF) composed of two prefusion F proteins to protect against both RSV-A and RSV-B. | Biological | Cases, Controls |
Primary outcome
Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease hospitalisation among infants.
Time frame: From birth through 6 months (0 to ≤180 days) of age.
RSV-positive lower respiratory tract disease hospitalisation occurring 0 to ≤180 days after birth.
3 secondary outcomes
Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease hospitalisation among infants.
Time frame: From birth through 6 months (0 to ≤180 days) of age within key subgroups.
Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive severe lower respiratory tract disease hospitalisation among infants.
Time frame: From birth through 6 months (0 to ≤180 days) of age and within key subgroups.
Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive acute respiratory illness hospitalisation among infants.
Time frame: From birth through 6 months (0 to ≤180 days) of age and within key subgroups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus (RSV) and Respiratory Syncytial Virus, run by Pfizer at 1 site in Australia.
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 5 inclusion and 6 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 19 Nov 2025. 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 Australia. 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?
Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease hospitalisation among infants. (time frame: From birth through 6 months (0 to ≤180 days) of age.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.