InfluenzaPhase 4NCT04523324
Immunogenicity Trial of Recombinant Influenza Vaccine Among HCP in Israel
A Phase 4 study testing Flublok™ Quadrivalent by Sanofi, Inc. and VaxigripTetra™ by Sanofi, Inc. in people with Influenza, run by Centers for Disease Control and Prevention at 2 sites in Israel.
Trial summary
This randomized, open-label, active-controlled trial will assess humoral immune responses to a single dose of 2019-20 recombinant hemagglutinin quadrivalent influenza vaccines (RIV4) compared with standard egg-based unadjuvanted quadrivalent influenza vaccines (IIV4) among healthcare personnel (HCP) vaccinated during… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Flublok™ Quadrivalent by Sanofi, Inc. and VaxigripTetra™ by Sanofi, Inc.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 577 participants
- Where
- 2 sitesIsrael
- Study dates
- 31 Oct 2019to 30 Aug 2022
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥18
- Current member of Clalit Health Services
- Consent to randomized receipt of influenza vaccination with either RIV4 or IIV4, or, if already vaccinated in the current year outside of the study, consent to receive a post-vaccination blood draw
- Participated in the SHIRI study and received influenza vaccination during the 2018-19 influenza season (Group 1)
- Participated in any year of the SHIRI study, not vaccinated in 2018-2019, but vaccinated in at least one study year (Group 1 supplemental)
- Participated in the SHIRI study during all three years, regardless of vaccination status (Group 1 supplemental)
- Participated in any year of the SHIRI study and had PCR-confirmed influenza virus infection during any of the three study years (Group 2)
Who cannot join
- Already received an influenza vaccine during the current influenza season
- Not willing or able to get the flu vaccines being used in this study;
- Previous hypersensitivity reaction to the study vaccines, or any vaccine, as reported by the subject
- Received any non-influenza vaccine (e.g., Hepatitis B or other vaccine recommended for HCP) in the 4 weeks prior to the first study visit or plans to receive a vaccine in the 4 weeks following the first study visit
- Currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication), or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive an experimental agent during participation in this study.
- Any condition or employment status that the potential participant or local study site principle investigator (PI) believes may interfere with successful completion of the study prior to December 2019, including being currently pregnant.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Soroka Medical Center
Beersheba
Rabin Medical Center-Beilinson
Petah Tikva
About this study
Official title: Randomized Comparison of the Immunogenicity of Recombinant and Egg-based Influenza Vaccines Among Healthcare Personnel in Israel
This randomized, open-label, active-controlled trial will assess humoral immune responses to a single dose of 2019-20 recombinant hemagglutinin quadrivalent influenza vaccines (RIV4) compared with standard egg-based unadjuvanted quadrivalent influenza vaccines (IIV4) among healthcare personnel (HCP) vaccinated during the previous 2018-19 season with IIV4. The trial will be conducted at two hospital sites in Israel during the 2019-20 influenza season among HCP who were enrolled in the Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI).
Read the detailed description
This is a randomized, open-label study design. Starting in July 2019, approximately 550 to 700 HCP from two hospitals (275-350 per hospital site) in Israel will be enrolled. Following completion of a written consent form, participants will complete an enrollment survey and grant permission for review of information collected during the SHIRI study, including vaccination status and immune response during the SHIRI study years. Participants will complete an enrollment survey and grant permission to include and integrate information collected during the SHIRI study into the current study's data, including health history, influenza vaccination history, and immune response to vaccination during the SHIRI study years. HCP will be randomly assigned 1:1 to receive a single dose of IIV4 licensed in Israel (expected to be Vaxigrip® Quadrivalent, 15µg of HA per strain) or RIV4 (Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain) during August-October of 2019. Adverse events following vaccination will be monitored and documented. Blood specimens will be collected prior to vaccination and approximately 28 days after to evaluate immune responses to vaccination.
Eligible HCP who were already vaccinated with Vaxigrip, the vaccine that is routinely available in Israel, at the time they are approached to join the study, will be invited to join the study as part of the Vaxigrip arm. Like randomized participants, participants who were vaccinated with Vaxigrip outside the study will complete a written consent form, an enrollment survey and grant permission for review of information collected during the SHIRI study, including vaccination status and immune response during the SHIRI study years. As part of the consent form, participants will record the estimated date that they received the vaccine, and the location, and will authorize study staff to verify the date of current-year Vaxigrip vaccination in the Clalit EMR and with the hospital vaccination staff. Participants will complete an enrollment survey and grant permission to include and integrate information collected during the SHIRI study into the current study's data, including health history, influenza vaccination history, and immune response to vaccination during the SHIRI study years. Blood specimens will be collected approximately 28 days after to evaluate immune responses to vaccination.
- Conditions
- Influenza
- Being tested
- Flublok™ Quadrivalent by Sanofi, Inc., VaxigripTetra™ by Sanofi, Inc.
- Keywords
- Influenza, Healthcare personnel, Immunogenicity, Repeat vaccination
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flublok™ Quadrivalent by Sanofi, Inc.Biological
0.5 mL intramuscular dose of Flublok
VaxigripTetra™ by Sanofi, Inc.Biological
0.5 mL intramuscular dose of Vaxigrip
| Study group | Role | What they receive |
|---|---|---|
| RIV4 (Flublok Quadrivalent) | Active comparator | Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Receives: Biological: Flublok™ Quadrivalent by Sanofi, Inc. |
| IIV4 (Vaxigrip Quadrivalent) | Active comparator | VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based Receives: Biological: VaxigripTetra™ by Sanofi, Inc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-vaccination Geometric Mean Titer Against Influenza Virus A/H1N1
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for influenza virus A/H1N1
Measured: Day 28 days after vaccination
Geometric Mean Titer Ratio (GMR) Against Influenza Virus A/H1N1
The ratio of the pre- vs. post-vaccination titer against influenza virus A/H1N1 following a single dose of RIV4 versus IIV4.
Measured: 0 to 28 days after vaccination
Post-vaccination Geometric Mean Titer Against Egg-grown Influenza Virus A/H3N2
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for egg-grown influenza virus A/H3N2
Measured: Day 28 days after vaccination
Geometric Mean Titer Ratio (GMR) Against Egg-grown Influenza Virus A/H3N2
The ratio of the pre- vs. post-vaccination titer against egg-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4.
Measured: 0 to 28 days after vaccination
Post-vaccination GMT Against Cell-grown Influenza Virus A/H3N2
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for cell-grown influenza virus A/H3N2
Measured: Day 28 days after vaccination
Geometric Mean Titer Ratio (GMR) Against Cell-grown Influenza Virus A/H3N2
The ratio of the pre- vs. post-vaccination titer against cell-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4.
Measured: 0 to 28 days after vaccination
Post-vaccination Geometric Mean Titer Against Influenza B(Victoria)
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Victoria)
Measured: Day 28 days after vaccination
Geometric Mean Titer Ratio (GMR) Against Influenza B(Victoria)
The ratio of the pre- vs. post-vaccination titer against Influenza B(Victoria) following a single dose of RIV4 versus IIV4.
Measured: 0 to 28 days after vaccination
Post-vaccination Geometric Mean Titer Against Influenza B(Yamagata)
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Yamagata)
Measured: Day 28 days after vaccination
Geometric Mean Titer Ratio (GMR) Against Influenza B(Yamagata)
The ratio of the pre- vs. post-vaccination titer against Influenza B(Yamagata) following a single dose of RIV4 versus IIV4.
Measured: 0 to 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start31 Oct 2019
- Primary completion30 Jan 2020
- Study completion30 Aug 2022
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 (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Abt Associates, Clalit Research Institute, Soroka University Medical Center, Rabin Medical Center, University of Michigan
- Responsible party
- Sponsor
- Investigators
- Mark G Thompson, PhD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523324
- Sponsor's protocol ID
- 7250
- Other IDs
- 200-2016-91806
- Status last verified
- Nov 2023
- First submitted
- 19 Aug 2020
- Last updated
- 15 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plans
Publications
Hirsch A, Katz MA, Laufer Peretz A, Greenberg D, Wendlandt R, Shemer Avni Y, Newes-Adeyi G, Gofer I, Leventer-Roberts M, Davidovitch N, Rosenthal A, Gur-Arie R, Hertz T, Glatman-Freedman A, Monto AS, Azziz-Baumgartner E, Ferdinands JM, Martin ET, Malosh RE, Neyra Quijandria JM, Levine M, Campbell W, Balicer R, Thompson MG; SHIRI workgroup. Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI): study protocol. BMC Infect Dis. 2018 Nov 6;18(1):550. doi: 10.1186/s12879-018-3444-7.
PubMed 30400834Fowlkes AL, Peretz A, Greenberg D, Hirsch A, Martin ET, Levine MZ, Edwards L, Radke S, Lauring AS, Ferdinands JM, Zhang C, Yoo YM, Dreiher J, Newes-Adeyi G, Azziz-Baumgartner E, Fry AM, Monto AS, Balicer R, Thompson MG, Katz MA. Randomised immunogenicity trial comparing 2019-2020 recombinant and egg-based influenza vaccines among frequently vaccinated healthcare personnel in Israel. Int J Infect Dis. 2024 Dec;149:107260. doi: 10.1016/j.ijid.2024.107260. Epub 2024 Oct 10.
PubMed 39395753
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of the Immunogenicity of Recombinant and Egg-based Influenza Vaccines Among Healthcare Personnel in Israel
- ClinicalTrials.gov ID
- NCT04523324
- Acronym / sponsor ID
- 7250
- Conditions
- Influenza
- Keywords
- Influenza, Healthcare personnel, Immunogenicity, Repeat vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Abt Associates, Clalit Research Institute, Soroka University Medical Center, Rabin Medical Center, University of Michigan
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Posted 15 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, open-label, active-controlled trial will assess humoral immune responses to a single dose of 2019-20 recombinant hemagglutinin quadrivalent influenza vaccines (RIV4) compared with standard egg-based unadjuvanted quadrivalent influenza vaccines (IIV4) among healthcare personnel (HCP) vaccinated during the previous 2018-19 season with IIV4. The trial will be conducted at two hospital sites in Israel during the 2019-20 influenza season among HCP who were enrolled in the Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI).
Detailed description
This is a randomized, open-label study design. Starting in July 2019, approximately 550 to 700 HCP from two hospitals (275-350 per hospital site) in Israel will be enrolled. Following completion of a written consent form, participants will complete an enrollment survey and grant permission for review of information collected during the SHIRI study, including vaccination status and immune response during the SHIRI study years. Participants will complete an enrollment survey and grant permission to include and integrate information collected during the SHIRI study into the current study's data, including health history, influenza vaccination history, and immune response to vaccination during the SHIRI study years. HCP will be randomly assigned 1:1 to receive a single dose of IIV4 licensed in Israel (expected to be Vaxigrip® Quadrivalent, 15µg of HA per strain) or RIV4 (Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain) during August-October of 2019. Adverse events following vaccination will be monitored and documented. Blood specimens will be collected prior to vaccination and approximately 28 days after to evaluate immune responses to vaccination.
Eligible HCP who were already vaccinated with Vaxigrip, the vaccine that is routinely available in Israel, at the time they are approached to join the study, will be invited to join the study as part of the Vaxigrip arm. Like randomized participants, participants who were vaccinated with Vaxigrip outside the study will complete a written consent form, an enrollment survey and grant permission for review of information collected during the SHIRI study, including vaccination status and immune response during the SHIRI study years. As part of the consent form, participants will record the estimated date that they received the vaccine, and the location, and will authorize study staff to verify the date of current-year Vaxigrip vaccination in the Clalit EMR and with the hospital vaccination staff. Participants will complete an enrollment survey and grant permission to include and integrate information collected during the SHIRI study into the current study's data, including health history, influenza vaccination history, and immune response to vaccination during the SHIRI study years. Blood specimens will be collected approximately 28 days after to evaluate immune responses to vaccination.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIV4 (Flublok Quadrivalent) | Active comparator | Biological: Flublok™ Quadrivalent by Sanofi, Inc.Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain |
| IIV4 (Vaxigrip Quadrivalent) | Active comparator | Biological: VaxigripTetra™ by Sanofi, Inc.VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18
- Current member of Clalit Health Services
- Consent to randomized receipt of influenza vaccination with either RIV4 or IIV4, or, if already vaccinated in the current year outside of the study, consent to receive a post-vaccination blood draw
- Participated in the SHIRI study and received influenza vaccination during the 2018-19 influenza season (Group 1)
- Participated in any year of the SHIRI study, not vaccinated in 2018-2019, but vaccinated in at least one study year (Group 1 supplemental)
Key exclusion criteria (6 listed)
- Already received an influenza vaccine during the current influenza season
- Not willing or able to get the flu vaccines being used in this study;
- Previous hypersensitivity reaction to the study vaccines, or any vaccine, as reported by the subject
- Received any non-influenza vaccine (e.g., Hepatitis B or other vaccine recommended for HCP) in the 4 weeks prior to the first study visit or plans to receive a vaccine in the 4 weeks following the first study visit
- Currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication), or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive an experimental agent during participation in this study.
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 |
|---|---|---|
| Flublok™ Quadrivalent by Sanofi, Inc.0.5 mL intramuscular dose of Flublok | Biological | RIV4 (Flublok Quadrivalent) |
| VaxigripTetra™ by Sanofi, Inc.0.5 mL intramuscular dose of Vaxigrip | Biological | IIV4 (Vaxigrip Quadrivalent) |
Primary outcome
Post-vaccination Geometric Mean Titer Against Influenza Virus A/H1N1
Time frame: Day 28 days after vaccination
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for influenza virus A/H1N1
Geometric Mean Titer Ratio (GMR) Against Influenza Virus A/H1N1
Time frame: 0 to 28 days after vaccination
The ratio of the pre- vs. post-vaccination titer against influenza virus A/H1N1 following a single dose of RIV4 versus IIV4.
Post-vaccination Geometric Mean Titer Against Egg-grown Influenza Virus A/H3N2
Time frame: Day 28 days after vaccination
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for egg-grown influenza virus A/H3N2
Geometric Mean Titer Ratio (GMR) Against Egg-grown Influenza Virus A/H3N2
Time frame: 0 to 28 days after vaccination
The ratio of the pre- vs. post-vaccination titer against egg-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4.
Post-vaccination GMT Against Cell-grown Influenza Virus A/H3N2
Time frame: Day 28 days after vaccination
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for cell-grown influenza virus A/H3N2
Geometric Mean Titer Ratio (GMR) Against Cell-grown Influenza Virus A/H3N2
Time frame: 0 to 28 days after vaccination
The ratio of the pre- vs. post-vaccination titer against cell-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4.
Post-vaccination Geometric Mean Titer Against Influenza B(Victoria)
Time frame: Day 28 days after vaccination
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Victoria)
Geometric Mean Titer Ratio (GMR) Against Influenza B(Victoria)
Time frame: 0 to 28 days after vaccination
The ratio of the pre- vs. post-vaccination titer against Influenza B(Victoria) following a single dose of RIV4 versus IIV4.
Post-vaccination Geometric Mean Titer Against Influenza B(Yamagata)
Time frame: Day 28 days after vaccination
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Yamagata)
Geometric Mean Titer Ratio (GMR) Against Influenza B(Yamagata)
Time frame: 0 to 28 days after vaccination
The ratio of the pre- vs. post-vaccination titer against Influenza B(Yamagata) following a single dose of RIV4 versus IIV4.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30400834Hirsch A, Katz MA, Laufer Peretz A, Greenberg D, Wendlandt R, Shemer Avni Y, Newes-Adeyi G, Gofer I, Leventer-Roberts M, Davidovitch N, Rosenthal A, Gur-Arie R, Hertz T, Glatman-Freedman A, Monto AS, Azziz-Baumgartner E, Ferdinands JM, Martin ET, Malosh RE, Neyra Quijandria JM, Levine M, Campbell W, Balicer R, Thompson MG; SHIRI workgroup. Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI): study protocol. BMC Infect Dis. 2018 Nov 6;18(1):550. doi: 10.1186/s12879-018-3444-7.
- Derived from this study: PubMed 39395753Fowlkes AL, Peretz A, Greenberg D, Hirsch A, Martin ET, Levine MZ, Edwards L, Radke S, Lauring AS, Ferdinands JM, Zhang C, Yoo YM, Dreiher J, Newes-Adeyi G, Azziz-Baumgartner E, Fry AM, Monto AS, Balicer R, Thompson MG, Katz MA. Randomised immunogenicity trial comparing 2019-2020 recombinant and egg-based influenza vaccines among frequently vaccinated healthcare personnel in Israel. Int J Infect Dis. 2024 Dec;149:107260. doi: 10.1016/j.ijid.2024.107260. Epub 2024 Oct 10.
- Individual participant dataSharing planned: No. No current plans
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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.
Mark G Thompson, PhD principal investigator
Centers for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flublok™ Quadrivalent by Sanofi, Inc. and VaxigripTetra™ by Sanofi, Inc. in people with Influenza, run by Centers for Disease Control and Prevention at 2 sites in Israel.
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 7 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: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 15 Nov 2023). 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?
Post-vaccination Geometric Mean Titer Against Influenza Virus A/H1N1 (time frame: Day 28 days after vaccination). The study lists 10 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 NCT04523324, which also lists 2 linked publications.
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 15 Nov 2023.