InfluenzaPhase 4NCT03722589
Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP
A Phase 4 study testing Flublok, Flucelvax and Fluarix in people with Influenza, run by Centers for Disease Control and Prevention at 2 sites in United States.
Trial summary
This randomized, open-label trial will assess humoral and cell-mediated immune responses to cell culture-based and recombinant unadjuvanted quadrivalent influenza vaccines compared to conventional egg-based unadjuvanted quadrivalent standard dose (15µg of HA per strain) influenza vaccines among persons aged 18-64… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Flublok, Flucelvax and Fluarix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 944 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Sep 2018to 31 Jul 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare personnel (HCP) who have direct contact with patients, including dentists and other dental health personnel
- Enrolled in Scott \& White Healthcare or Kaiser Permanente health network for at least one month
- Aged 18-64 years for newly enrolled participants
- Aged 18-65 years for participants who were originally enrolled in year one of the study and return for year 2
- Available and willing to participate in study follow-up through the end of the 2019-2020 influenza season (i.e. at least approximately 18 months if enrolled during season 1 or 6 months if enrolled during season 2)
- Received an egg-based standard dose influenza vaccine during the 2018-2019 influenza season (for participants enrolled for the first-time during year two)
Who cannot join
- Already received an influenza vaccine during the current influenza season
- Previous hypersensitivity reaction to the study vaccines as reported by the subject
- Received any vaccine in the 4 weeks prior to the first study visit or plans to receive a vaccine (other than influenza vaccine provided through the study protocol) 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 that the principle investigator (PI) believes may interfere with successful completion of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente Northwest
Portland, Oregon, 97227
Baylor Scott and White Health
Temple, Texas, 76543
About this study
Official title: Randomized Open-Label Trial to Compare the Immunogenicity of Cell Culture-Based and Recombinant Unadjuvanted Quadrivalent Influenza Vaccines to Conventional Egg-Based Unadjuvanted Quadrivalent Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years
This randomized, open-label trial will assess humoral and cell-mediated immune responses to cell culture-based and recombinant unadjuvanted quadrivalent influenza vaccines compared to conventional egg-based unadjuvanted quadrivalent standard dose (15µg of HA per strain) influenza vaccines among persons aged 18-64 years. The trial will be conducted at two sites in the United States during two influenza seasons (2018-19 and 2019-20). Stratified enrollment procedures will be used to enroll a mix of participants based on age.
Read the detailed description
In year 1 of the trial (the 2018-19 Northern Hemisphere influenza season), eligible participants at each site will be randomized 2:2:1:1 to receive a single dose of cell culture-based vaccine (Flucelvax™ Quadrivalent by Seqirus, Inc., 15µg of HA per strain) versus recombinant vaccine (Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain) versus one of two standard dose egg-based vaccines (Fluzone® Quadrivalent by Sanofi Pasteur, 15µg of HA per strain and Fluarix® Quadrivalent by GlaxoSmithKlein, 15µg of HA per strain) during August-September of 2018. All study vaccines are licensed for use in adults aged >18 years in the United States. Participants will have blood collected just prior to vaccination and at approximately 28 days and 6 months post-vaccination (or at the end of influenza virus circulation as determined by available surveillance data) to evaluate humoral immune responses to vaccination.
In year 1, sites will aim to enroll 864 participants (432 per site) at the start of the 2018-19 season, including up to 200 participants (up to 100 per site) who will contribute additional blood at all study visits to evaluate cell-mediated immune responses to vaccination. Efforts will be made to retain participants enrolled in the first year of the study for both years of the study. Sites will also enroll additional participants at the start of the 2019-20 season to make up for participants who withdraw or are lost to follow-up prior to the start of the 2019-20 season. Both participants and study investigators will be aware of study arm assignments with the exception of laboratory investigators who will be blinded to study arm assignment until testing is completed, as appropriate.
In year 1 , relative efficacy of single doses of study vaccines will be assessed by comparing immunologic responses to vaccination among participants between study arms using Fluzone® Quadrivalent and Fluarix® Quadrivalent as the comparator groups for participants in the Flucelvax™ Quadrivalent or Flublok® Quadrivalent arms. In addition, the effect of frequency of prior vaccination during the preceding five years on immunologic responses to vaccine will be evaluated in subgroup analysis. Both humoral (influenza antibody) and cell-mediated (influenza- specific CD4 and CD8 T cell) immune responses will be evaluated.
In year 2 of the trial, (the 2019-20 Northern Hemisphere influenza season), participants from the first year of the trial who received Flucelvax™ Quadrivalent or Flublok® Quadrivalent will be randomized 1:1 to receive Flucelvax™ Quadrivalent or Flublok® Quadrivalent, and participants who received an egg-based standard-dose vaccine in year one (Fluzone® Quadrivalent or Fluarix Quadrivalent) will be randomized 1:1:1 to receive Flucelvax™ Quadrivalent , Flublok® Quadrivalent , or Fluzone® Quadrivalent. In addition, both sites will enroll additional participants in year 2 to achieve a total of 150 participants per site (including participants who continue from year one plus additional newly enrolled participants) who received egg-based standard dose influenza vaccine during the 2018-2019 influenza season and who will be randomized 1:1:1 to receive Flucelvax™ Quadrivalent, Flublok® Quadrivalent, or Fluzone® Quadrivalent in year two. The Kaiser Permanente Northwest site site will also enroll up to 80 new participants for a non-randomized study arm that will receive Fluzone® High-Dose. All study vaccines except Fluzone High-Dose are licensed for use in adults aged >=18 years in the United States. Fluzone High-Dose is licensed for use in adults aged >=64 years in the United States and will be used off-label in this trial. Participants will have blood collected just prior to vaccination and at approximately 28 days post-vaccination (or at the end of influenza virus circulation as determined by available surveillance data) to evaluate humoral immune responses to vaccination. Additional blood will be collected from a subset of participants pre-vaccination and at approximately 7 and 28 days post-vaccination to evaluate cell-mediated immune responses to vaccination.
In year 2, sites will aim to retain from year 1 or newly enroll 750 participants.
Deaths and/or adverse events were not monitored/assessed in any arms for any flu seasons
- Conditions
- Influenza
- Being tested
- Flublok, Flucelvax, Fluarix, Fluzone, Fluzone High-Dose
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlublokBiological
0.5 mL intramuscular dose of Flublok
FlucelvaxBiological
0.5 mL intramuscular dose of Flucelvax
FluarixBiological
0.5 mL intramuscular dose of Fluarix
FluzoneBiological
0.5 mL intramuscular dose of Fluzone
Fluzone High-DoseBiological
0.5 mL intramuscular dose of Fluzone
| Study group | Role | What they receive |
|---|---|---|
| Flublok (Recombinant) | Active comparator | Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Receives: Biological: Flublok |
| Flucelvax (Cell-based) | Active comparator | Flucelvax™ Quadrivalent by Seqirus, Inc., 15µg of HA per strain Receives: Biological: Flucelvax |
| Fluarix (Egg-based) | Active comparator | Fluarix® Quadrivalent by GlaxoSmithKlein, 15µg of HA per strain Receives: Biological: Fluarix |
| Fluzone (Egg-based) | Active comparator | Fluzone® Quadrivalent by Sanofi Pasteur, 15µg of HA per strain Receives: Biological: Fluzone |
| Fluzone (Egg-based) High-Dose | Active comparator | Fluzone® Trivalent High-Dose by Sanofi Pasteur, 60µg of HA per strain Receives: Biological: Fluzone High-Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microneutralization (MN) Assay Response to Cell-grown Influenza A/H3N2 - Seroconversion Rate (SCR)
MN responses to the cell-grown influenza A/H3N2 vaccine reference viruses for each study season at approximately 28 days post-vaccination, including by assessing SCR in the various vaccine arms defined as the proportion of participants with paired samples that achieved ≥ 4 fold rises comparing post- versus pre-vaccination titers, and post vaccination titers ≥ 40
Measured: 28 days post-vaccination during year 1
Microneutralization (MN) Assay Response to Cell-grown Influenza A/H3N2 - Seroconversion Rate (SCR)
MN responses to the cell-grown influenza A/H3N2 vaccine reference viruses for each study season at approximately 28 days post-vaccination, including by assessing SCR in the various vaccine arms defined as the proportion of participants with paired samples that achieved ≥ 4 fold rises comparing post- versus pre-vaccination titers, and post vaccination titers ≥ 40
Measured: 28 days post-vaccination during year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start12 Sep 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
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 (3)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 944 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Baylor Scott and White Health, Kaiser Permanente, Abt Associates
- Responsible party
- Sponsor
- Investigators
- Fatimah Dawood, MD, Principal investigator, Centers for Disease Control and PreventionBrendan Flannery, PhD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722589
- Sponsor's protocol ID
- 7179
- Status last verified
- Jul 2024
- First submitted
- 15 Oct 2018
- Last updated
- 22 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available to contractor and site research staff. This data can be made available to other researchers upon request.
Publications
Liu F, Gross FL, Joshi S, Gaglani M, Naleway AL, Murthy K, Groom HC, Wesley MG, Edwards LJ, Grant L, Kim SS, Sambhara S, Gangappa S, Tumpey T, Thompson MG, Fry AM, Flannery B, Dawood FS, Levine MZ. Redirecting antibody responses from egg-adapted epitopes following repeat vaccination with recombinant or cell culture-based versus egg-based influenza vaccines. Nat Commun. 2024 Jan 4;15(1):254. doi: 10.1038/s41467-023-44551-x.
PubMed 38177116Gaglani M, Kim SS, Naleway AL, Levine MZ, Edwards L, Murthy K, Dunnigan K, Zunie T, Groom H, Ball S, Jeddy Z, Hunt D, Wesley MG, Sambhara S, Gangappa S, Grant L, Cao W, Gross FL, Mishina M, Fry AM, Thompson MG, Dawood FS, Flannery B. Effect of Repeat Vaccination on Immunogenicity of Quadrivalent Cell-Culture and Recombinant Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years: A Randomized, Open-Label Trial. Clin Infect Dis. 2023 Feb 8;76(3):e1168-e1176. doi: 10.1093/cid/ciac683.
PubMed 36031405Dawood FS, Naleway AL, Flannery B, Levine MZ, Murthy K, Sambhara S, Gangappa S, Edwards L, Ball S, Grant L, Belongia E, Bounds K, Cao W, Gross FL, Groom H, Fry AM, Rentz Hunt D, Jeddy Z, Mishina M, Kim SS, Wesley MG, Spencer S, Thompson MG, Gaglani M. Comparison of the Immunogenicity of Cell Culture-Based and Recombinant Quadrivalent Influenza Vaccines to Conventional Egg-Based Quadrivalent Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years: A Randomized Open-Label Trial. Clin Infect Dis. 2021 Dec 6;73(11):1973-1981. doi: 10.1093/cid/ciab566.
PubMed 34245243
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-Label Trial to Compare the Immunogenicity of Cell Culture-Based and Recombinant Unadjuvanted Quadrivalent Influenza Vaccines to Conventional Egg-Based Unadjuvanted Quadrivalent Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years
- ClinicalTrials.gov ID
- NCT03722589
- Acronym / sponsor ID
- 7179
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 944 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Baylor Scott and White Health, Kaiser Permanente, Abt Associates
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Posted 22 Jul 2024
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 trial will assess humoral and cell-mediated immune responses to cell culture-based and recombinant unadjuvanted quadrivalent influenza vaccines compared to conventional egg-based unadjuvanted quadrivalent standard dose (15µg of HA per strain) influenza vaccines among persons aged 18-64 years. The trial will be conducted at two sites in the United States during two influenza seasons (2018-19 and 2019-20). Stratified enrollment procedures will be used to enroll a mix of participants based on age.
Detailed description
In year 1 of the trial (the 2018-19 Northern Hemisphere influenza season), eligible participants at each site will be randomized 2:2:1:1 to receive a single dose of cell culture-based vaccine (Flucelvax™ Quadrivalent by Seqirus, Inc., 15µg of HA per strain) versus recombinant vaccine (Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain) versus one of two standard dose egg-based vaccines (Fluzone® Quadrivalent by Sanofi Pasteur, 15µg of HA per strain and Fluarix® Quadrivalent by GlaxoSmithKlein, 15µg of HA per strain) during August-September of 2018. All study vaccines are licensed for use in adults aged >18 years in the United States. Participants will have blood collected just prior to vaccination and at approximately 28 days and 6 months post-vaccination (or at the end of influenza virus circulation as determined by available surveillance data) to evaluate humoral immune responses to vaccination.
In year 1, sites will aim to enroll 864 participants (432 per site) at the start of the 2018-19 season, including up to 200 participants (up to 100 per site) who will contribute additional blood at all study visits to evaluate cell-mediated immune responses to vaccination. Efforts will be made to retain participants enrolled in the first year of the study for both years of the study. Sites will also enroll additional participants at the start of the 2019-20 season to make up for participants who withdraw or are lost to follow-up prior to the start of the 2019-20 season. Both participants and study investigators will be aware of study arm assignments with the exception of laboratory investigators who will be blinded to study arm assignment until testing is completed, as appropriate.
In year 1 , relative efficacy of single doses of study vaccines will be assessed by comparing immunologic responses to vaccination among participants between study arms using Fluzone® Quadrivalent and Fluarix® Quadrivalent as the comparator groups for participants in the Flucelvax™ Quadrivalent or Flublok® Quadrivalent arms. In addition, the effect of frequency of prior vaccination during the preceding five years on immunologic responses to vaccine will be evaluated in subgroup analysis. Both humoral (influenza antibody) and cell-mediated (influenza- specific CD4 and CD8 T cell) immune responses will be evaluated.
In year 2 of the trial, (the 2019-20 Northern Hemisphere influenza season), participants from the first year of the trial who received Flucelvax™ Quadrivalent or Flublok® Quadrivalent will be randomized 1:1 to receive Flucelvax™ Quadrivalent or Flublok® Quadrivalent, and participants who received an egg-based standard-dose vaccine in year one (Fluzone® Quadrivalent or Fluarix Quadrivalent) will be randomized 1:1:1 to receive Flucelvax™ Quadrivalent , Flublok® Quadrivalent , or Fluzone® Quadrivalent. In addition, both sites will enroll additional participants in year 2 to achieve a total of 150 participants per site (including participants who continue from year one plus additional newly enrolled participants) who received egg-based standard dose influenza vaccine during the 2018-2019 influenza season and who will be randomized 1:1:1 to receive Flucelvax™ Quadrivalent, Flublok® Quadrivalent, or Fluzone® Quadrivalent in year two. The Kaiser Permanente Northwest site site will also enroll up to 80 new participants for a non-randomized study arm that will receive Fluzone® High-Dose. All study vaccines except Fluzone High-Dose are licensed for use in adults aged >=18 years in the United States. Fluzone High-Dose is licensed for use in adults aged >=64 years in the United States and will be used off-label in this trial. Participants will have blood collected just prior to vaccination and at approximately 28 days post-vaccination (or at the end of influenza virus circulation as determined by available surveillance data) to evaluate humoral immune responses to vaccination. Additional blood will be collected from a subset of participants pre-vaccination and at approximately 7 and 28 days post-vaccination to evaluate cell-mediated immune responses to vaccination.
In year 2, sites will aim to retain from year 1 or newly enroll 750 participants.
Deaths and/or adverse events were not monitored/assessed in any arms for any flu seasons
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Flublok (Recombinant) | Active comparator | Biological: FlublokFlublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain |
| Flucelvax (Cell-based) | Active comparator | Biological: FlucelvaxFlucelvax™ Quadrivalent by Seqirus, Inc., 15µg of HA per strain |
| Fluarix (Egg-based) | Active comparator | Biological: FluarixFluarix® Quadrivalent by GlaxoSmithKlein, 15µg of HA per strain |
| Fluzone (Egg-based) | Active comparator | Biological: FluzoneFluzone® Quadrivalent by Sanofi Pasteur, 15µg of HA per strain |
| Fluzone (Egg-based) High-Dose | Active comparator | Biological: Fluzone High-DoseFluzone® Trivalent High-Dose by Sanofi Pasteur, 60µg of HA per strain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthcare personnel (HCP) who have direct contact with patients, including dentists and other dental health personnel
- Enrolled in Scott \& White Healthcare or Kaiser Permanente health network for at least one month
- Aged 18-64 years for newly enrolled participants
- Aged 18-65 years for participants who were originally enrolled in year one of the study and return for year 2
- Available and willing to participate in study follow-up through the end of the 2019-2020 influenza season (i.e. at least approximately 18 months if enrolled during season 1 or 6 months if enrolled during season 2)
Key exclusion criteria (5 listed)
- Already received an influenza vaccine during the current influenza season
- Previous hypersensitivity reaction to the study vaccines as reported by the subject
- Received any vaccine in the 4 weeks prior to the first study visit or plans to receive a vaccine (other than influenza vaccine provided through the study protocol) 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 that the principle investigator (PI) believes may interfere with successful completion of the 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 |
|---|---|---|
| Flublok0.5 mL intramuscular dose of Flublok | Biological | Flublok (Recombinant) |
| Flucelvax0.5 mL intramuscular dose of Flucelvax | Biological | Flucelvax (Cell-based) |
| Fluarix0.5 mL intramuscular dose of Fluarix | Biological | Fluarix (Egg-based) |
| Fluzone0.5 mL intramuscular dose of Fluzone | Biological | Fluzone (Egg-based) |
| Fluzone High-Dose0.5 mL intramuscular dose of Fluzone | Biological | Fluzone (Egg-based) High-Dose |
Primary outcome
Microneutralization (MN) Assay Response to Cell-grown Influenza A/H3N2 - Seroconversion Rate (SCR)
Time frame: 28 days post-vaccination during year 1
MN responses to the cell-grown influenza A/H3N2 vaccine reference viruses for each study season at approximately 28 days post-vaccination, including by assessing SCR in the various vaccine arms defined as the proportion of participants with paired samples that achieved ≥ 4 fold rises comparing post- versus pre-vaccination titers, and post vaccination titers ≥ 40
Microneutralization (MN) Assay Response to Cell-grown Influenza A/H3N2 - Seroconversion Rate (SCR)
Time frame: 28 days post-vaccination during year 2
MN responses to the cell-grown influenza A/H3N2 vaccine reference viruses for each study season at approximately 28 days post-vaccination, including by assessing SCR in the various vaccine arms defined as the proportion of participants with paired samples that achieved ≥ 4 fold rises comparing post- versus pre-vaccination titers, and post vaccination titers ≥ 40
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38177116Liu F, Gross FL, Joshi S, Gaglani M, Naleway AL, Murthy K, Groom HC, Wesley MG, Edwards LJ, Grant L, Kim SS, Sambhara S, Gangappa S, Tumpey T, Thompson MG, Fry AM, Flannery B, Dawood FS, Levine MZ. Redirecting antibody responses from egg-adapted epitopes following repeat vaccination with recombinant or cell culture-based versus egg-based influenza vaccines. Nat Commun. 2024 Jan 4;15(1):254. doi: 10.1038/s41467-023-44551-x.
- Derived from this study: PubMed 36031405Gaglani M, Kim SS, Naleway AL, Levine MZ, Edwards L, Murthy K, Dunnigan K, Zunie T, Groom H, Ball S, Jeddy Z, Hunt D, Wesley MG, Sambhara S, Gangappa S, Grant L, Cao W, Gross FL, Mishina M, Fry AM, Thompson MG, Dawood FS, Flannery B. Effect of Repeat Vaccination on Immunogenicity of Quadrivalent Cell-Culture and Recombinant Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years: A Randomized, Open-Label Trial. Clin Infect Dis. 2023 Feb 8;76(3):e1168-e1176. doi: 10.1093/cid/ciac683.
- Derived from this study: PubMed 34245243Dawood FS, Naleway AL, Flannery B, Levine MZ, Murthy K, Sambhara S, Gangappa S, Edwards L, Ball S, Grant L, Belongia E, Bounds K, Cao W, Gross FL, Groom H, Fry AM, Rentz Hunt D, Jeddy Z, Mishina M, Kim SS, Wesley MG, Spencer S, Thompson MG, Gaglani M. Comparison of the Immunogenicity of Cell Culture-Based and Recombinant Quadrivalent Influenza Vaccines to Conventional Egg-Based Quadrivalent Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years: A Randomized Open-Label Trial. Clin Infect Dis. 2021 Dec 6;73(11):1973-1981. doi: 10.1093/cid/ciab566.
- Individual participant dataSharing planned: Yes. IPD will be made available to contractor and site research staff. This data can be made available to other researchers upon request.
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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.
Fatimah Dawood, MD principal investigator
Centers for Disease Control and Prevention
Brendan Flannery, 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, Flucelvax and Fluarix in people with Influenza, run by Centers for Disease Control and Prevention at 2 sites 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 6 inclusion and 5 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 22 Jul 2024. 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 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.
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 22 Jul 2024). 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?
Microneutralization (MN) Assay Response to Cell-grown Influenza A/H3N2 - Seroconversion Rate (SCR) (time frame: 28 days post-vaccination during year 1). 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 NCT03722589, which also lists 3 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 22 Jul 2024.