Respiratory Syncytial Virus InfectionsPhase 2NCT04657198
Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study
A Phase 2 study testing RSVPreF3 OA investigational vaccine (GSK3844766A) in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 10 sites in 2 countries.
Trial summary
Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the parent study (NCT03814590). Based on safety and immunogenicity data from the parent study, RSVPreF3 OA investigational vaccine will be evaluated in further clinical research. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- RSVPreF3 OA investigational vaccine (GSK3844766A)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 9 Dec 2020to 25 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants, who received 2 doses of RSVPreF3 OA investigational vaccine and formulations with matched adjuvant in part B of the parent study RSV OA=ADJ-002: recombinant RSVPreF3 antigen doses of low, medium and high strengths with adjuvant.
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for the follow-up visit, be available for contact)
- Written informed consent obtained from the participant prior to performance of any study specific procedure.
Who cannot join
- Medical conditions
- Significant underlying illness or administered therapy that in the opinion of the investigator would be expected to prevent participation in the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on information on concomitant medication/vaccination collected prior to the study start and physical examination.
- Serious or unstable chronic illness that developed during or after the parent study. Patients with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as clinically stable.
- Recurrent or un-controlled neurological disorders or seizures that developed during or after the parent study. Participants with medically-controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
- Significant underlying illness that developed during or after the parent study, that in the opinion of the investigator would be expected to prevent completion of the study.
Show all 22Show fewer
- Lymphoproliferative disorder and malignancy developed during or after the parent study.
- Any medical condition that developed during or after the parent study, that in the judgment of the investigator would make intramuscular injection unsafe.
- Previous vaccination with RSV vaccine, other than the one in the parent study.
- Prior/Concomitant therapy
- Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the dose of study vaccine, or planned use during the study period.
- Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study vaccine administration, with the exception of inactivated, split virion and subunit influenza vaccines which can be administered up to 14 days before or from 30 days after the study vaccination.
- Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the dose of study vaccine or planned administration during the study period.
- Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the vaccine dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
- Confirmed use or anticipated use of immunosuppressive/cytotoxic therapy.
- Prior/Concurrent clinical study experience
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
- Other exclusions
- Bedridden participants.
- Planned move to a location that will prohibit participating in the trial.
- History of chronic alcohol consumption and/or drug abuse that developed during or after the parent study as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
GSK Investigational Site
Elkridge, Maryland, 21075
GSK Investigational Site
Hickory, North Carolina, 28601
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
San Antonio, Texas, 78229
Belgium3 sites
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Wilrijk, 2610
About this study
Official title: A Phase 2b, Open-label, Multi-center, Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 Older Adults (OA) Investigational Vaccine Administered Intramuscularly 18 Months Post-Dose 2 in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study
Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the parent study (NCT03814590). Based on safety and immunogenicity data from the parent study, RSVPreF3 OA investigational vaccine will be evaluated in further clinical research. Participants in selected groups will be invited to participate in this extension study. All participants who will be enrolled in the current extension study will receive the RSV investigational vaccine approximately 18 months after they received their respective dose-2 in the parent study.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- RSVPreF3 OA investigational vaccine (GSK3844766A)
- Keywords
- Respiratory syncytial virus, Vaccine, Safety, Immunogenicity
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSVPreF3 OA investigational vaccine (GSK3844766A)Biological
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1 (18 months post-Dose 2 in the RSV OA=ADJ-002 parent study).
| Study group | Role | What they receive |
|---|---|---|
| Group High Dose_Adjuvanted | Experimental | Participants in one of the high dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group High Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by intramuscular (IM) injection in the non-dominant arm. Receives: Biological: RSVPreF3 OA investigational vaccine (GSK3844766A) |
| Group Medium Dose_Adjuvanted | Experimental | Participants in one of the medium dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group Medium Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by IM injection in the non-dominant arm. Receives: Biological: RSVPreF3 OA investigational vaccine (GSK3844766A) |
| Group Low Dose_Adjuvanted | Experimental | Participants in one of the low dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group Low Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by IM injection in the non-dominant arm. Receives: Biological: RSVPreF3 OA investigational vaccine (GSK3844766A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Solicited Administration Site Adverse Events (AEs)
Assessed solicited administration site AEs are erythema, pain and swelling. Any pain is defined as any pain regardless of intensity grade. Any injection site erythema/swelling is scored with a diameter larger than (>) 20 millimeters (mm).
Measured: During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)
Number of Participants With Any Solicited Systemic AEs
Assessed solicited systemic AE is fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity). Any is defined as occurrence of the symptom regardless of intensity grade or relation to study.
Measured: During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)
Number of Participants With Any Unsolicited AEs
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination.
Measured: During the 30-day follow-up period post-vaccination (i.e., on the day of vaccination [Day 1] and 29 subsequent days)
Number of Participants With Any Serious Adverse Events (SAEs) up to 30 Days Post-vaccination
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.
Measured: From Day 1 up to 30 days post-vaccination (Day 31)
Number of Participants With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days Post-vaccination
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any is defined as the occurrence of any pIMD regardless of intensity grade or relation to study vaccination.
Measured: From Day 1 up to 30 days post-vaccination (Day 31)
Humoral Immune Response in Terms of Neutralizing Antibody Titers Against Respiratory Syncytial Virus (RSV)-Serotype A
Serological assays for the determination of functional antibodies against RSV-A are performed by neutralization assay. Anti RSV-A neutralizing antibody titers are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60).
Measured: At 30 days post-vaccination (Day 31)
Humoral Immune Response in Terms of Neutralizing Antibody Titers Against RSV-serotype B
Serological assays for the determination of functional antibodies against RSV-B are performed by neutralization assay. Anti RSV-B neutralizing antibody titers are given as GMTs and expressed as ED60.
Measured: At 30 days post-vaccination (Day 31)
Secondary outcomes (4)
Humoral Immune Response in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations
The detection and the quantification of total IgG antibodies directed against RSVPreF3 in human serum samples were based on an indirect Enzyme-Linked Immunosorbent Assay (ELISA). Anti RSVPreF3 antibody concentration is given in geometric mean concentration (GMC) and is expressed in ELISA Laboratory Units per milliliter (ELU/mL).
Measured: At 30 days post-vaccination (Day 31)
Frequency of RSVPreF3-specific Cluster of Differentiation 4+ (CD4+) T-cells Identified as Expressing at Least Two Markers
Among markers expressed are interleukin-2 (IL2), cluster of 40 ligand (CD40L), tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Measured: At 30 days post-vaccination (Day 31)
Number of Participants With Any SAEs, up the End of Follow-up Study Period (Month 6)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
Measured: From Day 1 up to the end of follow-up period (Month 6)
Number of Participants Reporting pIMDs up to the End of Follow-up Study Period (Month 6)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Measured: From Day 1 up to the end of follow-up period (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start9 Dec 2020
- Primary completion3 Jun 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657198
- Sponsor's protocol ID
- 213569
- Other IDs
- 2020-000692-21
- Status last verified
- Jun 2022
- First submitted
- 1 Dec 2020
- Last updated
- 29 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Leroux-Roels I, Van Ranst M, Vandermeulen C, Abeele CV, De Schrevel N, Salaun B, Verheust C, David MP, Kotb S, Hulstrom V. Safety and Immunogenicity of a Revaccination With a Respiratory Syncytial Virus Prefusion F Vaccine in Older Adults: A Phase 2b Study. J Infect Dis. 2024 Feb 14;229(2):355-366. doi: 10.1093/infdis/jiad321.
PubMed 37699064
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Open-label, Multi-center, Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 Older Adults (OA) Investigational Vaccine Administered Intramuscularly 18 Months Post-Dose 2 in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study
- ClinicalTrials.gov ID
- NCT04657198
- Acronym / sponsor ID
- 213569
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory syncytial virus, Vaccine, Safety, Immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Posted 29 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the parent study (NCT03814590). Based on safety and immunogenicity data from the parent study, RSVPreF3 OA investigational vaccine will be evaluated in further clinical research. Participants in selected groups will be invited to participate in this extension study. All participants who will be enrolled in the current extension study will receive the RSV investigational vaccine approximately 18 months after they received their respective dose-2 in the parent study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group High Dose_Adjuvanted | Experimental | Biological: RSVPreF3 OA investigational vaccine (GSK3844766A)Participants in one of the high dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group High Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by intramuscular (IM) injection in the non-dominant arm. |
| Group Medium Dose_Adjuvanted | Experimental | Biological: RSVPreF3 OA investigational vaccine (GSK3844766A)Participants in one of the medium dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group Medium Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by IM injection in the non-dominant arm. |
| Group Low Dose_Adjuvanted | Experimental | Biological: RSVPreF3 OA investigational vaccine (GSK3844766A)Participants in one of the low dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group Low Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by IM injection in the non-dominant arm. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female participants, who received 2 doses of RSVPreF3 OA investigational vaccine and formulations with matched adjuvant in part B of the parent study RSV OA=ADJ-002: recombinant RSVPreF3 antigen doses of low, medium and high strengths with adjuvant.
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for the follow-up visit, be available for contact)
- Written informed consent obtained from the participant prior to performance of any study specific procedure.
Key exclusion criteria (22 listed)
- Medical conditions
- Significant underlying illness or administered therapy that in the opinion of the investigator would be expected to prevent participation in the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on information on concomitant medication/vaccination collected prior to the study start and physical examination.
- Serious or unstable chronic illness that developed during or after the parent study. Patients with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as clinically stable.
- Recurrent or un-controlled neurological disorders or seizures that developed during or after the parent study. Participants with medically-controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
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 |
|---|---|---|
| RSVPreF3 OA investigational vaccine (GSK3844766A)RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1 (18 months post-Dose 2 in the RSV OA=ADJ-002 parent study). | Biological | Group High Dose_Adjuvanted, Group Low Dose_Adjuvanted, Group Medium Dose_Adjuvanted |
Primary outcome
Number of Participants With Any Solicited Administration Site Adverse Events (AEs)
Time frame: During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)
Assessed solicited administration site AEs are erythema, pain and swelling. Any pain is defined as any pain regardless of intensity grade. Any injection site erythema/swelling is scored with a diameter larger than (>) 20 millimeters (mm).
Number of Participants With Any Solicited Systemic AEs
Time frame: During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)
Assessed solicited systemic AE is fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity). Any is defined as occurrence of the symptom regardless of intensity grade or relation to study.
Number of Participants With Any Unsolicited AEs
Time frame: During the 30-day follow-up period post-vaccination (i.e., on the day of vaccination [Day 1] and 29 subsequent days)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination.
Number of Participants With Any Serious Adverse Events (SAEs) up to 30 Days Post-vaccination
Time frame: From Day 1 up to 30 days post-vaccination (Day 31)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.
Number of Participants With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days Post-vaccination
Time frame: From Day 1 up to 30 days post-vaccination (Day 31)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any is defined as the occurrence of any pIMD regardless of intensity grade or relation to study vaccination.
Humoral Immune Response in Terms of Neutralizing Antibody Titers Against Respiratory Syncytial Virus (RSV)-Serotype A
Time frame: At 30 days post-vaccination (Day 31)
Serological assays for the determination of functional antibodies against RSV-A are performed by neutralization assay. Anti RSV-A neutralizing antibody titers are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60).
Humoral Immune Response in Terms of Neutralizing Antibody Titers Against RSV-serotype B
Time frame: At 30 days post-vaccination (Day 31)
Serological assays for the determination of functional antibodies against RSV-B are performed by neutralization assay. Anti RSV-B neutralizing antibody titers are given as GMTs and expressed as ED60.
4 secondary outcomes
Humoral Immune Response in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations
Time frame: At 30 days post-vaccination (Day 31)
Frequency of RSVPreF3-specific Cluster of Differentiation 4+ (CD4+) T-cells Identified as Expressing at Least Two Markers
Time frame: At 30 days post-vaccination (Day 31)
Number of Participants With Any SAEs, up the End of Follow-up Study Period (Month 6)
Time frame: From Day 1 up to the end of follow-up period (Month 6)
Number of Participants Reporting pIMDs up to the End of Follow-up Study Period (Month 6)
Time frame: From Day 1 up to the end of follow-up period (Month 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37699064Leroux-Roels I, Van Ranst M, Vandermeulen C, Abeele CV, De Schrevel N, Salaun B, Verheust C, David MP, Kotb S, Hulstrom V. Safety and Immunogenicity of a Revaccination With a Respiratory Syncytial Virus Prefusion F Vaccine in Older Adults: A Phase 2b Study. J Infect Dis. 2024 Feb 14;229(2):355-366. doi: 10.1093/infdis/jiad321.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
Related trials for Respiratory Syncytial Virus Infections
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RSVPreF3 OA investigational vaccine (GSK3844766A) in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 10 sites in 2 countries.
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 3 inclusion and 22 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: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Any Solicited Administration Site Adverse Events (AEs) (time frame: During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)). The study lists 7 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 NCT04657198, 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 29 Jun 2022.