InfluenzaPhase 4PAIVEDNCT03734237
A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD
A Phase 4 study testing Egg based influenza vaccines, Recombinant influenza vaccines and Cell-culture based influenza vaccines in people with Influenza and Influenza-like Illness, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 9 sites in United States.
Trial summary
A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019, 2019-2020, 2020-2021, and 2021-2022). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza-like Illness, Influenza Vaccines
- What is being tested?
- Egg based influenza vaccines, Recombinant influenza vaccines and Cell-culture based influenza vaccines
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,448 participants
- Where
- 9 sitesUnited States
- Study dates
- 6 Nov 2018to 30 Jun 2026
- 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
- Eligible for care in Department of Defense medical facilities (Defense Enrollment Eligibility Reporting System eligible)
- ≥18 years of age.
- At a participating Military Treatment Facility site for the purpose of receiving a seasonal (2018-2019, 2019-2020,2020-2021, 2021-2022) influenza vaccination.
- Able to speak English and able to provide informed consent
- Able to receive and respond to texts and/or emails, or a military recruit
Who cannot join
- Adults intending to receive or who have received the current seasons FluMist Vaccine (LAIV)
- Adults who have already received a flu vaccine within the current season
- Individual who cannot receive a flu vaccine or standard dosing due to another medical condition
- Allergic to gentamicin, polymyxin and/or neomycin
- Individuals who fail to meet the inclusion criteria
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
United States Naval Academy
Annapolis, Maryland, 21402
USU
Bethesda, Maryland, 20307
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Womack Army Medical Center
Fort Bragg, North Carolina, 28310
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23704
Lackland Airforce Base
San Antonio, Texas, 78243
Naval Medical Center San Diego
San Diego, California, 34800
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019, 2019-2020, 2020-2021, and 2021-2022).
Read the detailed description
This four-year, pragmatic, prospective study will compare the effectiveness of licensed egg-based inactivated influenza vaccines to the effectiveness of two other types of licensed vaccines, the cell-culture based inactivated influenza vaccine and the recombinant influenza vaccine, in the prevention of laboratory-confirmed influenza infection in active duty members, military retirees, and other DoD beneficiaries. Military treatment facilities (MTFs) in the United States will participate in this protocol. Enrollment will be restricted to adults (≥18 years and older) who are preparing to receive seasonal influenza vaccination at participating DoD sites. Subjects will be randomized to receive one of the three licensed influenza vaccines types for evaluation of effectiveness. There is no exclusion for pregnancy, as none of these licensed products are contraindicated in pregnant women.
- Conditions
- Influenza, Influenza-like Illness, Influenza Vaccines
- Being tested
- Egg based influenza vaccines, Recombinant influenza vaccines, Cell-culture based influenza vaccines
- Keywords
- Influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg based influenza vaccinesBiological
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
Recombinant influenza vaccinesBiological
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
Cell-culture based influenza vaccinesBiological
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
| Study group | Role | What they receive |
|---|---|---|
| Egg based influenza vaccines | Active comparator | Quadrivalent egg-based vaccines, which contain an inactivated form of the virus. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. All egg-based vaccines are FDA licensed for use in the United States. Receives: Biological: Egg based influenza vaccines |
| Recombinant influenza vaccines | Active comparator | FluBlok, recombinant HA influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flublok Quadrivalent is a quadrivalent recombinant influenza vaccine that has been licensed by the FDA for use in the United States. Receives: Biological: Recombinant influenza vaccines |
| Cell-culture based influenza vaccines | Active comparator | Flucelvax, Madin-Darby canine kidney (MDCK)-cell-culture based inactivated influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flucelvax quadrivalent, the only cell-based flu vaccine FDA licensed for use in the United States. Receives: Biological: Cell-culture based influenza vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Laboratory Confirmed Influenza
Laboratory-confirmed influenza as ascertained by a sensitive and specific assay.
Measured: Onset > 13 days after vaccination up to 1 year
Secondary outcomes (4)
Hemagglutination Inhibition (HI) Titer Responses to Influenza Vaccine Strains.
Strain-specific seroconversion rate determined by reference hemagglutination inhibition assay.
Measured: Baseline to 21-35 days post vaccine
Pseudovirion Neutralization (PVN) Responses to Influenza Vaccine.
Neutralizing antibody responses (4-fold rise) to HA-psuedoviruses corresponding to vaccine-matched viruses, recently circulating influenza virus, and emerging influenza strain.
Measured: Baseline to 21-35 days post vaccine
Anti-Neuraminidase (Anti-NA) Titer Responses to Influenza Vaccine.
Anti-Neuraminidase (Anti-NA) titer responses determined by enzyme linked immuno-assay.
Measured: Baseline to 21-35 days post vaccine
Number of Participants With Influenza-Like Illness
Rate of protocol defined influenza-like illness ascertained by participant response to active surveillance.
Measured: Onset > 13 days after vaccination up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start6 Nov 2018
- Primary completion7 Jul 2022
- Study completion30 Jun 2026 (estimated)
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 (10)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
- Model description
- A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019,2019-2020, 2020-2021, and 2021-2022).
- Masking
- None (open label)
- Enrolment
- 15,448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Food and Drug Administration (FDA), US Department of Defense Armed Forces Health Surveillance Center, Naval Health Research Center, United States Air Force School of Aerospace Medicine, Uniformed Services University of the Health Sciences, Defense Health Agency
- Responsible party
- Sponsor
- Investigators
- Timothy Burgess, MD, Principal investigator, Uniformed Services University of the Health SciencesRhonda Colombo, MD, Study director, Infectious Diseases Clinical Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734237
- Sponsor's protocol ID
- IDCRP-120
- Other IDs
- AAI1201200007000
- Acronym
- PAIVED
- Status last verified
- Mar 2026
- First submitted
- 2 Nov 2018
- Last updated
- 2 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez JL, Cooper MJ, Myers CA, Cummings JF, Vest KG, Russell KL, Sanchez JL, Hiser MJ, Gaydos CA. Respiratory Infections in the U.S. Military: Recent Experience and Control. Clin Microbiol Rev. 2015 Jul;28(3):743-800. doi: 10.1128/CMR.00039-14.
PubMed 26085551Flannery B, Chung JR, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Monto AS, Martin ET, Foust A, Sessions W, Berman L, Barnes JR, Spencer S, Fry AM. Interim Estimates of 2017-18 Seasonal Influenza Vaccine Effectiveness - United States, February 2018. MMWR Morb Mortal Wkly Rep. 2018 Feb 16;67(6):180-185. doi: 10.15585/mmwr.mm6706a2.
PubMed 29447141Zost SJ, Parkhouse K, Gumina ME, Kim K, Diaz Perez S, Wilson PC, Treanor JJ, Sant AJ, Cobey S, Hensley SE. Contemporary H3N2 influenza viruses have a glycosylation site that alters binding of antibodies elicited by egg-adapted vaccine strains. Proc Natl Acad Sci U S A. 2017 Nov 21;114(47):12578-12583. doi: 10.1073/pnas.1712377114. Epub 2017 Nov 6.
PubMed 29109276Wu NC, Zost SJ, Thompson AJ, Oyen D, Nycholat CM, McBride R, Paulson JC, Hensley SE, Wilson IA. A structural explanation for the low effectiveness of the seasonal influenza H3N2 vaccine. PLoS Pathog. 2017 Oct 23;13(10):e1006682. doi: 10.1371/journal.ppat.1006682. eCollection 2017 Oct.
PubMed 29059230Skowronski DM, Janjua NZ, De Serres G, Sabaiduc S, Eshaghi A, Dickinson JA, Fonseca K, Winter AL, Gubbay JB, Krajden M, Petric M, Charest H, Bastien N, Kwindt TL, Mahmud SM, Van Caeseele P, Li Y. Low 2012-13 influenza vaccine effectiveness associated with mutation in the egg-adapted H3N2 vaccine strain not antigenic drift in circulating viruses. PLoS One. 2014 Mar 25;9(3):e92153. doi: 10.1371/journal.pone.0092153. eCollection 2014.
PubMed 24667168Cobey S, Gouma S, Parkhouse K, Chambers BS, Ertl HC, Schmader KE, Halpin RA, Lin X, Stockwell TB, Das SR, Landon E, Tesic V, Youngster I, Pinsky BA, Wentworth DE, Hensley SE, Grad YH. Poor Immunogenicity, Not Vaccine Strain Egg Adaptation, May Explain the Low H3N2 Influenza Vaccine Effectiveness in 2012-2013. Clin Infect Dis. 2018 Jul 18;67(3):327-333. doi: 10.1093/cid/ciy097.
PubMed 29471464Wang W, Butler EN, Veguilla V, Vassell R, Thomas JT, Moos M Jr, Ye Z, Hancock K, Weiss CD. Establishment of retroviral pseudotypes with influenza hemagglutinins from H1, H3, and H5 subtypes for sensitive and specific detection of neutralizing antibodies. J Virol Methods. 2008 Nov;153(2):111-9. doi: 10.1016/j.jviromet.2008.07.015. Epub 2008 Sep 4.
PubMed 18722473Wang W, Xie H, Ye Z, Vassell R, Weiss CD. Characterization of lentiviral pseudotypes with influenza H5N1 hemagglutinin and their performance in neutralization assays. J Virol Methods. 2010 May;165(2):305-10. doi: 10.1016/j.jviromet.2010.02.009. Epub 2010 Feb 11.
PubMed 20153374Kautz M, Schmidt K, Richard SA, Colombo RE, Epsi NJ, Ganesan A, Maves RC, Mende K, Schofield C, Montgomery JR, Pollett S, Larson DT, Fries AC, Burgess TH, Lalani T. Participant self-collected versus research coordinator-collected nasal swabs for respiratory viral surveillance following influenza-like illness. Front Public Health. 2026 Aug 19;14:1846269. doi: 10.3389/fpubh.2026.1846269. eCollection 2026.
PubMed 42688087Colombo RE, Richard SA, Schmidt K, Schofield C, Ganesan A, Campbell W, Hrncir D, Lalani T, Mende K, Markelz AE, Berjohn CM, Housel L, Becher D, Zell ER, Ewing D, Sundaram AK, Modi JR, Saperstein A, Tilley DH Jr, Williams A, McClenathan B, Collins L, Spooner C, Seshadri S, Fries A, Maves RC, Powers Iii JH, O'Connell RJ, Pollett SD, Simons MP, Coles CL, Burgess TH; PAIVED Study Group. Randomized Pragmatic Trial of the Comparative Effectiveness of Chicken Egg-Based Inactivated, Mammalian Cell Culture-Based Inactivated, and Recombinant Protein Quadrivalent Seasonal Influenza Vaccines in United States Military Health System Beneficiaries. Clin Infect Dis. 2025 Dec 24;81(5):e454-e463. doi: 10.1093/cid/ciaf503.
PubMed 40973113
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD
- ClinicalTrials.gov ID
- NCT03734237
- Acronym / sponsor ID
- PAIVED / IDCRP-120
- Conditions
- Influenza, Influenza-like Illness, Influenza Vaccines
- Keywords
- Influenza vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,448 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Food and Drug Administration (FDA), US Department of Defense Armed Forces Health Surveillance Center, Naval Health Research Center, United States Air Force School of Aerospace Medicine, Uniformed Services University of the Health Sciences, Defense Health Agency
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Nov 2018 (actual)
- Results
- Posted 24 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019, 2019-2020, 2020-2021, and 2021-2022).
Detailed description
This four-year, pragmatic, prospective study will compare the effectiveness of licensed egg-based inactivated influenza vaccines to the effectiveness of two other types of licensed vaccines, the cell-culture based inactivated influenza vaccine and the recombinant influenza vaccine, in the prevention of laboratory-confirmed influenza infection in active duty members, military retirees, and other DoD beneficiaries. Military treatment facilities (MTFs) in the United States will participate in this protocol. Enrollment will be restricted to adults (≥18 years and older) who are preparing to receive seasonal influenza vaccination at participating DoD sites. Subjects will be randomized to receive one of the three licensed influenza vaccines types for evaluation of effectiveness. There is no exclusion for pregnancy, as none of these licensed products are contraindicated in pregnant women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019,2019-2020, 2020-2021, and 2021-2022).
| Arm | Type | Receives |
|---|---|---|
| Egg based influenza vaccines | Active comparator | Biological: Egg based influenza vaccinesQuadrivalent egg-based vaccines, which contain an inactivated form of the virus. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. All egg-based vaccines are FDA licensed for use in the United States. |
| Recombinant influenza vaccines | Active comparator | Biological: Recombinant influenza vaccinesFluBlok, recombinant HA influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flublok Quadrivalent is a quadrivalent recombinant influenza vaccine that has been licensed by the FDA for use in the United States. |
| Cell-culture based influenza vaccines | Active comparator | Biological: Cell-culture based influenza vaccinesFlucelvax, Madin-Darby canine kidney (MDCK)-cell-culture based inactivated influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flucelvax quadrivalent, the only cell-based flu vaccine FDA licensed for use in the United States. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible for care in Department of Defense medical facilities (Defense Enrollment Eligibility Reporting System eligible)
- ≥18 years of age.
- At a participating Military Treatment Facility site for the purpose of receiving a seasonal (2018-2019, 2019-2020,2020-2021, 2021-2022) influenza vaccination.
- Able to speak English and able to provide informed consent
- Able to receive and respond to texts and/or emails, or a military recruit
Key exclusion criteria (5 listed)
- Adults intending to receive or who have received the current seasons FluMist Vaccine (LAIV)
- Adults who have already received a flu vaccine within the current season
- Individual who cannot receive a flu vaccine or standard dosing due to another medical condition
- Allergic to gentamicin, polymyxin and/or neomycin
- Individuals who fail to meet the inclusion criteria
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 |
|---|---|---|
| Egg based influenza vaccinesParticipants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States. | Biological | Egg based influenza vaccines |
| Recombinant influenza vaccinesParticipants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States. | Biological | Recombinant influenza vaccines |
| Cell-culture based influenza vaccinesParticipants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States. | Biological | Cell-culture based influenza vaccines |
Primary outcome
Number of Participants With Laboratory Confirmed Influenza
Time frame: Onset > 13 days after vaccination up to 1 year
Laboratory-confirmed influenza as ascertained by a sensitive and specific assay.
4 secondary outcomes
Hemagglutination Inhibition (HI) Titer Responses to Influenza Vaccine Strains.
Time frame: Baseline to 21-35 days post vaccine
Pseudovirion Neutralization (PVN) Responses to Influenza Vaccine.
Time frame: Baseline to 21-35 days post vaccine
Anti-Neuraminidase (Anti-NA) Titer Responses to Influenza Vaccine.
Time frame: Baseline to 21-35 days post vaccine
Number of Participants With Influenza-Like Illness
Time frame: Onset > 13 days after vaccination up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26085551Sanchez JL, Cooper MJ, Myers CA, Cummings JF, Vest KG, Russell KL, Sanchez JL, Hiser MJ, Gaydos CA. Respiratory Infections in the U.S. Military: Recent Experience and Control. Clin Microbiol Rev. 2015 Jul;28(3):743-800. doi: 10.1128/CMR.00039-14.
- Background: PubMed 29447141Flannery B, Chung JR, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Monto AS, Martin ET, Foust A, Sessions W, Berman L, Barnes JR, Spencer S, Fry AM. Interim Estimates of 2017-18 Seasonal Influenza Vaccine Effectiveness - United States, February 2018. MMWR Morb Mortal Wkly Rep. 2018 Feb 16;67(6):180-185. doi: 10.15585/mmwr.mm6706a2.
- Background: PubMed 29109276Zost SJ, Parkhouse K, Gumina ME, Kim K, Diaz Perez S, Wilson PC, Treanor JJ, Sant AJ, Cobey S, Hensley SE. Contemporary H3N2 influenza viruses have a glycosylation site that alters binding of antibodies elicited by egg-adapted vaccine strains. Proc Natl Acad Sci U S A. 2017 Nov 21;114(47):12578-12583. doi: 10.1073/pnas.1712377114. Epub 2017 Nov 6.
- Background: PubMed 29059230Wu NC, Zost SJ, Thompson AJ, Oyen D, Nycholat CM, McBride R, Paulson JC, Hensley SE, Wilson IA. A structural explanation for the low effectiveness of the seasonal influenza H3N2 vaccine. PLoS Pathog. 2017 Oct 23;13(10):e1006682. doi: 10.1371/journal.ppat.1006682. eCollection 2017 Oct.
- Background: PubMed 24667168Skowronski DM, Janjua NZ, De Serres G, Sabaiduc S, Eshaghi A, Dickinson JA, Fonseca K, Winter AL, Gubbay JB, Krajden M, Petric M, Charest H, Bastien N, Kwindt TL, Mahmud SM, Van Caeseele P, Li Y. Low 2012-13 influenza vaccine effectiveness associated with mutation in the egg-adapted H3N2 vaccine strain not antigenic drift in circulating viruses. PLoS One. 2014 Mar 25;9(3):e92153. doi: 10.1371/journal.pone.0092153. eCollection 2014.
- Background: PubMed 29471464Cobey S, Gouma S, Parkhouse K, Chambers BS, Ertl HC, Schmader KE, Halpin RA, Lin X, Stockwell TB, Das SR, Landon E, Tesic V, Youngster I, Pinsky BA, Wentworth DE, Hensley SE, Grad YH. Poor Immunogenicity, Not Vaccine Strain Egg Adaptation, May Explain the Low H3N2 Influenza Vaccine Effectiveness in 2012-2013. Clin Infect Dis. 2018 Jul 18;67(3):327-333. doi: 10.1093/cid/ciy097.
- Background: PubMed 18722473Wang W, Butler EN, Veguilla V, Vassell R, Thomas JT, Moos M Jr, Ye Z, Hancock K, Weiss CD. Establishment of retroviral pseudotypes with influenza hemagglutinins from H1, H3, and H5 subtypes for sensitive and specific detection of neutralizing antibodies. J Virol Methods. 2008 Nov;153(2):111-9. doi: 10.1016/j.jviromet.2008.07.015. Epub 2008 Sep 4.
- Background: PubMed 20153374Wang W, Xie H, Ye Z, Vassell R, Weiss CD. Characterization of lentiviral pseudotypes with influenza H5N1 hemagglutinin and their performance in neutralization assays. J Virol Methods. 2010 May;165(2):305-10. doi: 10.1016/j.jviromet.2010.02.009. Epub 2010 Feb 11.
- Derived from this study: PubMed 42688087Kautz M, Schmidt K, Richard SA, Colombo RE, Epsi NJ, Ganesan A, Maves RC, Mende K, Schofield C, Montgomery JR, Pollett S, Larson DT, Fries AC, Burgess TH, Lalani T. Participant self-collected versus research coordinator-collected nasal swabs for respiratory viral surveillance following influenza-like illness. Front Public Health. 2026 Aug 19;14:1846269. doi: 10.3389/fpubh.2026.1846269. eCollection 2026.
- Derived from this study: PubMed 40973113Colombo RE, Richard SA, Schmidt K, Schofield C, Ganesan A, Campbell W, Hrncir D, Lalani T, Mende K, Markelz AE, Berjohn CM, Housel L, Becher D, Zell ER, Ewing D, Sundaram AK, Modi JR, Saperstein A, Tilley DH Jr, Williams A, McClenathan B, Collins L, Spooner C, Seshadri S, Fries A, Maves RC, Powers Iii JH, O'Connell RJ, Pollett SD, Simons MP, Coles CL, Burgess TH; PAIVED Study Group. Randomized Pragmatic Trial of the Comparative Effectiveness of Chicken Egg-Based Inactivated, Mammalian Cell Culture-Based Inactivated, and Recombinant Protein Quadrivalent Seasonal Influenza Vaccines in United States Military Health System Beneficiaries. Clin Infect Dis. 2025 Dec 24;81(5):e454-e463. doi: 10.1093/cid/ciaf503.
- Individual participant dataSharing planned: No
Related trials for Influenza
Not yet recruitingPhase 2/3
Evaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza
Influenza, Human
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Not yet recruiting
Family Physician Nudges for Influenza Vaccination Among Older Adults
Influenza Vaccination
Recruiting
Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections
COVID-19 Respiratory Infection, Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
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.
Timothy Burgess, MD principal investigator
Uniformed Services University of the Health Sciences
Rhonda Colombo, MD study director
Infectious Diseases Clinical Research Program
9 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 Egg based influenza vaccines, Recombinant influenza vaccines and Cell-culture based influenza vaccines in people with Influenza and Influenza-like Illness, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 9 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 5 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 24 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?
Number of Participants With Laboratory Confirmed Influenza (time frame: Onset > 13 days after vaccination up to 1 year). 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 NCT03734237, which also lists 10 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 2 Apr 2026.