Influenza, HumanPhase 2NCT05874713
Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults
A Phase 2 study testing aH5N8c on Day 1, aH5N6c on Day 1 and aH5N8c on Day 22 in people with Influenza, Human and Infections, run by Seqirus at 9 sites in United States.
Trial summary
This Phase 2, randomized, observer-blind clinical study is evaluating 3 different priming and booster regimens with MF59-adjuvanted H5N8 and/or H5N6 cell culture-derived influenza vaccine (aH5N8c; aH5N6c). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, Infections, Respiratory Tract Infections
- What is being tested?
- aH5N8c on Day 1, aH5N6c on Day 1 and aH5N8c on Day 22
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 9 sitesUnited States
- Study dates
- 7 Jun 2023to 25 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Individuals of ≥18 years of age on the day of informed consent.
- Individuals who or whose legally acceptable representative(s) have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Individuals who can comply with study procedures including follow-up.
- Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days before the first study vaccination and plan to do so until 2 months after the last study vaccination.
- Individuals must provide a baseline blood sample prior to randomization and vaccination.
Who cannot join
- Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until 2 months after the last study vaccination.
- Progressive, unstable or uncontrolled clinical conditions.
- Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- Abnormal function of the immune system resulting from:
- Clinical conditions.
Show all 17Show fewer
- Systemic administration of corticosteroids at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted.
- Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
- History of any medical condition considered an AESI.
- Received immunoglobulins with immunomodulating effects or any blood products within 180 days prior to informed consent.
- Individuals who previously received an H5 influenza vaccine or have a known history of H5 influenza infection prior to enrollment.
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent or are unwilling to refuse participation in another clinical study at any time during the conduct of this study.
- Study personnel or immediate family or household member of study personnel.
- Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the individual due to participation in the study.
- Individuals who received any other vaccines (with the exception of COVID-19 vaccines) within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from any of the 3 scheduled study vaccinations.
- Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from any of the 3 scheduled study vaccinations.
- A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Velocity Clinical Research
Baton Rouge, Louisiana, 70809
Cope Family Medicine
Bountiful, Utah, 84010
Cullman Clinical Trials
Cullman, Alabama, 35055
Medical Care LLC
Elizabethton, Tennessee, 37643
Velocity Clinical Research
Grand Island, Nebraska, 68803
Lifeline Primary Care
Lilburn, Georgia, 30047
Georgia Clinic
Norcross, Georgia, 30092
Velocity Clinical Research
Norfolk, Nebraska, 68701
Velocity Clinical Research
Sioux City, Iowa, 51106
About this study
Official title: A Phase 2, Multi-Center, Randomized, Observer-Blind Study, to Evaluate Safety and Immunogenicity of Homologous or Heterologous Priming and Booster Vaccinations With H5N8 or H5N6 MF59-adjuvanted, Cell Culture-derived Influenza Vaccine in Healthy Subjects ≥18 Years of Age
This Phase 2, randomized, observer-blind clinical study is evaluating 3 different priming and booster regimens with MF59-adjuvanted H5N8 and/or H5N6 cell culture-derived influenza vaccine (aH5N8c; aH5N6c). Approximately 480 healthy adult subjects are to be randomized into 1 of 3 possible treatment groups, stratified by age group (18-64 years and ≥65 years) and by poultry worker status (yes/no). Each subject will receive a priming influenza vaccine injection on Day 1 and Day 22 and a booster vaccination on Day 202. Subjects will be followed up for approximately 6 months after the booster injection.
The primary immunogenicity analysis is based on antibody responses against H5N8 and H5N6 as measured by hemagglutination inhibition (HI) assay on Day 1, Day 22, Day 29, Day 43, Day 202, Day 209 (H5N8 only), and Day 223.
- Conditions
- Influenza, Human, Infections, Respiratory Tract Infections, Virus Diseases, Infection Viral
- Being tested
- aH5N8c on Day 1, aH5N6c on Day 1, aH5N8c on Day 22, aH5N6c on Day 22, aH5N8c on Day 202
- Keywords
- Influenza, Vaccine, MF59, Adjuvant, H5N8, H5N6, Pandemic, Avian
- Medical subject headings
- Influenza, Human, Infections, Respiratory Tract Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aH5N8c on Day 1Biological
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N8 vaccine (aH5N8c) for intramuscular administration, containing intermediate dose H5N8 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)
aH5N6c on Day 1Biological
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular administration, containing intermediate dose H5N6 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)
aH5N8c on Day 22Biological
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N8 vaccine (aH5N8c) for intramuscular administration, containing intermediate dose H5N8 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)
aH5N6c on Day 22Biological
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular administration, containing intermediate dose H5N6 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)
aH5N8c on Day 202Biological
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N8 vaccine (aH5N8c) for intramuscular administration, containing intermediate dose H5N8 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Eligible subjects who have been randomized to receive aH5N8c on Day 1, Day 22 and Day 202 Receives: Biological: aH5N8c on Day 1; Biological: aH5N8c on Day 22; Biological: aH5N8c on Day 202 |
| Arm B | Experimental | Eligible subjects who have been randomized to receive aH5N8c on Day 1, aH5N6c on Day 22, and aH5N8c on Day 202 Receives: Biological: aH5N8c on Day 1; Biological: aH5N6c on Day 22; Biological: aH5N8c on Day 202 |
| Arm C | Experimental | Eligible subjects who have been randomized to receive aH5N6c on Day 1 and aH5N8c on Day 22 and Day 202 Receives: Biological: aH5N6c on Day 1; Biological: aH5N8c on Day 22; Biological: aH5N8c on Day 202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N8 strain - Day 1
GMT (HI) prevaccination
Measured: Day 1
GMT of HI antibodies against H5N8 strain - Day 22
GMT (HI) 3 weeks post first priming vaccination
Measured: Day 22
GMT of HI antibodies against H5N8 strain - Day 43
GMT (HI) 3 weeks post second priming vaccination
Measured: Day 43
GMT of HI antibodies against H5N8 strain - Day 202
GMT (HI) pre booster vaccination
Measured: Day 202
GMT of HI antibodies against H5N8 strain - Day 209
GMT (HI) 1 week post booster vaccination
Measured: Day 209
GMT of HI antibodies against H5N8 strain - Day 223
GMT (HI) 3 weeks post booster vaccination
Measured: Day 223
GMT of HI antibodies against H5N6 strain - Day 1
GMT (HI) prevaccination
Measured: Day 1
GMT of HI antibodies against H5N6 strain - Day 22
GMT (HI) 3 weeks post first priming vaccination
Measured: Day 22
GMT of HI antibodies against H5N6 strain - Day 43
GMT (HI) 3 weeks post second priming vaccination
Measured: Day 43
GMT of HI antibodies against H5N6 strain - Day 202
GMT (HI) pre booster vaccination
Measured: Day 202
GMT of HI antibodies against H5N6 strain - Day 223
GMT (HI) 3 weeks post booster vaccination
Measured: Day 223
Geometric mean fold increase (GMFI) of HI antibodies against H5N8 strain - Day 22
GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination
Measured: Day 22
GMFI of HI antibodies against H5N8 strain - Day 43
GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination
Measured: Day 43
GMFI of HI antibodies against H5N8 strain - Day 209
GMFI (HI) 1 week post booster vaccination compared to pre booster vaccination
Measured: Day 209
GMFI of HI antibodies against H5N8 strain - Day 223
GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination
Measured: Day 223
GMFI of HI antibodies against H5N6 strain - Day 22
GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination
Measured: Day 22
GMFI of HI antibodies against H5N6 strain - Day 43
GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination
Measured: Day 43
GMFI of HI antibodies against H5N6 strain - Day 223
GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination
Measured: Day 223
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 1
% ≥1:40 (HI) prevaccination
Measured: Day 1
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 22
% ≥1:40 (HI) 3 weeks post first priming vaccination
Measured: Day 22
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 43
% ≥1:40 (HI) 3 weeks post second priming vaccination
Measured: Day 43
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 209
% ≥1:40 (HI) 1 week post booster vaccination
Measured: Day 209
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 223
% ≥1:40 (HI) 3 weeks post booster vaccination
Measured: Day 223
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 1
% ≥1:40 (HI) prevaccination
Measured: Day 1
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 22
% ≥1:40 (HI) 3 weeks post first priming vaccination
Measured: Day 22
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 43
% ≥1:40 (HI) 3 weeks post second priming vaccination
Measured: Day 43
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 223
% ≥1:40 (HI) 3 weeks post booster vaccination
Measured: Day 223
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 22
% seroconversion (HI) 3 weeks post first priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Measured: Day 22
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 43
% seroconversion (HI) 3 weeks post second priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Measured: Day 43
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 209
% seroconversion (HI) 1 week post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Measured: Day 209
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 223
% seroconversion (HI) 3 weeks post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Measured: Day 223
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 22
% seroconversion (HI) 3 weeks post first priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Measured: Day 22
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 43
% seroconversion (HI) 3 weeks post second priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Measured: Day 43
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 223
% seroconversion (HI) 3 weeks post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Measured: Day 223
Secondary outcomes (19)
Frequency and severity of solicited local and systemic adverse events (AEs)
For 7 consecutive days following each vaccination (ie, Day 1 through Day 7, Day 22 through Day 28, and Day 202 through 208, or until symptom resolution if ongoing at Day 7, Day 28 or Day 208 for a maximum of 14 days postvaccination).
Measured: Day 1 through Day 7, Day 22 through Day 28, and Day 202 through 208
Frequency and severity of unsolicited AEs
For 3 weeks following each vaccination
Measured: Day 1 through Day 43 and Day 202 through Day 223
Frequency and severity of serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI), and medically attended AEs (MAAEs)
From first vaccination until study completion
Measured: Day 1 through Day 382
GMT of HI antibodies against H5N8 strain - Persistence
GMT (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination
Measured: Day 202, Day 382
GMT of HI antibodies against H5N6 strain - Persistence
GMT (HI) 6 months post 2nd priming vaccination
Measured: Day 202
GMFI of HI antibodies against H5N8 strain - Persistence
GMFI (HI) 6 months post 2nd priming vaccination compared to prevaccination (Day 1), and 6 months post booster vaccination compared to prevaccination (Day 1) and compared to pre booster vaccination (Day 202)
Measured: Day 202, Day 382
GMFI of HI antibodies against H5N6 strain - Persistence
GMFI (HI) 6 months post 2nd priming vaccination compared to prevaccination
Measured: Day 202
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Persistence
% ≥1:40 (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination
Measured: Day 202, Day 382
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Persistence
% ≥1:40 (HI) 6 months post 2nd priming vaccination
Measured: Day 202
Percentages of subjects with seroconversion by HI against H5N8 strain - Persistence
% seroconversion (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Measured: Day 202, Day 382
Percentages of subjects with seroconversion by HI against H5N6 strain - Persistence
% seroconversion (HI) 6 months post 2nd priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Measured: Day 202
GMT of microneutralization (MN) antibodies against H5N8 strain
GMT (MN) prevaccination, 3 weeks post priming vaccinations, pre booster vaccination and 3 weeks post booster vaccination
Measured: Day 1, Day 22, Day 43, Day 202, Day 223
GMT of MN antibodies against H5N6 strain
GMT (MN) prevaccination, 3 weeks post 2nd priming vaccination, pre booster vaccination and 3 weeks post booster vaccination
Measured: Day 1, Day 43, Day 202, Day 223
GMFI of MN antibodies against H5N8 strain
GMFI (MN) 3 weeks post priming vaccinations and 6 months post 2nd priming vaccination compared to prevaccination (Day 1), and 3 weeks post booster vaccination compared to pre booster vaccination (Day 202)
Measured: Day 22, Day 43, Day 202, Day 223
GMFI of MN antibodies against H5N6 strain
GMFI (MN) 3 weeks and 6 months post 2nd priming vaccination compared to prevaccination (Day 1), and 3 weeks post booster vaccination compared to pre booster vaccination (Day 202)
Measured: Day 43, Day 202, Day 223
Percentages of subjects with MN titers ≥1:40 against H5N8 strain
% ≥1:40 (MN) prevaccination, 3 weeks post priming vaccinations, pre booster vaccination, and 3 weeks post booster vaccination
Measured: Day 1, Day 22, Day 43, Day 202, Day 223
Percentages of subjects with MN titers ≥1:40 against H5N6 strain
% ≥1:40 (MN) prevaccination, 3 weeks post 2nd priming vaccination, pre booster vaccination, and 3 weeks post booster vaccination
Measured: Day 1, Day 43, Day 202, Day 223
Percentages of subjects with seroconversion by MN against H5N8 strain
% seroconversion (MN) 3 weeks post priming vaccinations, pre booster vaccination, and 3 weeks post booster vaccination, defined as a ≥4-fold increase in MN titer postvaccination for subjects with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with prevaccination titer <LLOQ
Measured: Day 22, Day 43, Day 202, Day 209, Day 223
Percentages of subjects with seroconversion by MN against H5N6 strain
% seroconversion (MN) 3 weeks post 2nd priming vaccination, pre booster vaccination, and 3 weeks post booster vaccination, defined as a ≥4-fold increase in MN titer postvaccination for subjects with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with prevaccination titer <LLOQ
Measured: Day 43, Day 202, Day 209, Day 223
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start7 Jun 2023
- Primary completion25 Apr 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects are randomized in a 2:1:1 ratio to Treatment Arm A, B, or C, respectively, and will receive two priming doses of the allocated aH5N8c/aH5N6c vaccine 3 weeks apart, ie, at Day 1 and Day 22, and a booster dose of aH5N8c vaccine at Day 202.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Therapeutic Area Head, Study chair, Seqirus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874713
- Sponsor's protocol ID
- V205_01
- Status last verified
- Dec 2024
- First submitted
- 4 May 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Observer-Blind Study, to Evaluate Safety and Immunogenicity of Homologous or Heterologous Priming and Booster Vaccinations With H5N8 or H5N6 MF59-adjuvanted, Cell Culture-derived Influenza Vaccine in Healthy Subjects ≥18 Years of Age
- ClinicalTrials.gov ID
- NCT05874713
- Acronym / sponsor ID
- V205_01
- Conditions
- Influenza, Human, Infections, Respiratory Tract Infections, Virus Diseases, Infection Viral
- Keywords
- Influenza, Vaccine, MF59, Adjuvant, H5N8, H5N6, Pandemic, Avian
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2, randomized, observer-blind clinical study is evaluating 3 different priming and booster regimens with MF59-adjuvanted H5N8 and/or H5N6 cell culture-derived influenza vaccine (aH5N8c; aH5N6c). Approximately 480 healthy adult subjects are to be randomized into 1 of 3 possible treatment groups, stratified by age group (18-64 years and ≥65 years) and by poultry worker status (yes/no). Each subject will receive a priming influenza vaccine injection on Day 1 and Day 22 and a booster vaccination on Day 202. Subjects will be followed up for approximately 6 months after the booster injection.
The primary immunogenicity analysis is based on antibody responses against H5N8 and H5N6 as measured by hemagglutination inhibition (HI) assay on Day 1, Day 22, Day 29, Day 43, Day 202, Day 209 (H5N8 only), and Day 223.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Eligible subjects are randomized in a 2:1:1 ratio to Treatment Arm A, B, or C, respectively, and will receive two priming doses of the allocated aH5N8c/aH5N6c vaccine 3 weeks apart, ie, at Day 1 and Day 22, and a booster dose of aH5N8c vaccine at Day 202.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: aH5N8c on Day 1, Biological: aH5N8c on Day 22, Biological: aH5N8c on Day 202Eligible subjects who have been randomized to receive aH5N8c on Day 1, Day 22 and Day 202 |
| Arm B | Experimental | Biological: aH5N8c on Day 1, Biological: aH5N6c on Day 22, Biological: aH5N8c on Day 202Eligible subjects who have been randomized to receive aH5N8c on Day 1, aH5N6c on Day 22, and aH5N8c on Day 202 |
| Arm C | Experimental | Biological: aH5N6c on Day 1, Biological: aH5N8c on Day 22, Biological: aH5N8c on Day 202Eligible subjects who have been randomized to receive aH5N6c on Day 1 and aH5N8c on Day 22 and Day 202 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals of ≥18 years of age on the day of informed consent.
- Individuals who or whose legally acceptable representative(s) have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Individuals who can comply with study procedures including follow-up.
- Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days before the first study vaccination and plan to do so until 2 months after the last study vaccination.
- Individuals must provide a baseline blood sample prior to randomization and vaccination.
Key exclusion criteria (17 listed)
- Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until 2 months after the last study vaccination.
- Progressive, unstable or uncontrolled clinical conditions.
- Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- Abnormal function of the immune system resulting from:
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 |
|---|---|---|
| aH5N8c on Day 1MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N8 vaccine (aH5N8c) for intramuscular administration, containing intermediate dose H5N8 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume) | Biological | Arm A, Arm B |
| aH5N6c on Day 1MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular administration, containing intermediate dose H5N6 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume) | Biological | Arm C |
| aH5N8c on Day 22MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N8 vaccine (aH5N8c) for intramuscular administration, containing intermediate dose H5N8 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume) | Biological | Arm A, Arm C |
| aH5N6c on Day 22MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular administration, containing intermediate dose H5N6 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume) | Biological | Arm B |
| aH5N8c on Day 202MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N8 vaccine (aH5N8c) for intramuscular administration, containing intermediate dose H5N8 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume) | Biological | Arm A, Arm B, Arm C |
Primary outcome
Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N8 strain - Day 1
Time frame: Day 1
GMT (HI) prevaccination
GMT of HI antibodies against H5N8 strain - Day 22
Time frame: Day 22
GMT (HI) 3 weeks post first priming vaccination
GMT of HI antibodies against H5N8 strain - Day 43
Time frame: Day 43
GMT (HI) 3 weeks post second priming vaccination
GMT of HI antibodies against H5N8 strain - Day 202
Time frame: Day 202
GMT (HI) pre booster vaccination
GMT of HI antibodies against H5N8 strain - Day 209
Time frame: Day 209
GMT (HI) 1 week post booster vaccination
GMT of HI antibodies against H5N8 strain - Day 223
Time frame: Day 223
GMT (HI) 3 weeks post booster vaccination
GMT of HI antibodies against H5N6 strain - Day 1
Time frame: Day 1
GMT (HI) prevaccination
GMT of HI antibodies against H5N6 strain - Day 22
Time frame: Day 22
GMT (HI) 3 weeks post first priming vaccination
GMT of HI antibodies against H5N6 strain - Day 43
Time frame: Day 43
GMT (HI) 3 weeks post second priming vaccination
GMT of HI antibodies against H5N6 strain - Day 202
Time frame: Day 202
GMT (HI) pre booster vaccination
GMT of HI antibodies against H5N6 strain - Day 223
Time frame: Day 223
GMT (HI) 3 weeks post booster vaccination
Geometric mean fold increase (GMFI) of HI antibodies against H5N8 strain - Day 22
Time frame: Day 22
GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination
GMFI of HI antibodies against H5N8 strain - Day 43
Time frame: Day 43
GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination
GMFI of HI antibodies against H5N8 strain - Day 209
Time frame: Day 209
GMFI (HI) 1 week post booster vaccination compared to pre booster vaccination
GMFI of HI antibodies against H5N8 strain - Day 223
Time frame: Day 223
GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination
GMFI of HI antibodies against H5N6 strain - Day 22
Time frame: Day 22
GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination
GMFI of HI antibodies against H5N6 strain - Day 43
Time frame: Day 43
GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination
GMFI of HI antibodies against H5N6 strain - Day 223
Time frame: Day 223
GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 1
Time frame: Day 1
% ≥1:40 (HI) prevaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 22
Time frame: Day 22
% ≥1:40 (HI) 3 weeks post first priming vaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 43
Time frame: Day 43
% ≥1:40 (HI) 3 weeks post second priming vaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 209
Time frame: Day 209
% ≥1:40 (HI) 1 week post booster vaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 223
Time frame: Day 223
% ≥1:40 (HI) 3 weeks post booster vaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 1
Time frame: Day 1
% ≥1:40 (HI) prevaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 22
Time frame: Day 22
% ≥1:40 (HI) 3 weeks post first priming vaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 43
Time frame: Day 43
% ≥1:40 (HI) 3 weeks post second priming vaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 223
Time frame: Day 223
% ≥1:40 (HI) 3 weeks post booster vaccination
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 22
Time frame: Day 22
% seroconversion (HI) 3 weeks post first priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 43
Time frame: Day 43
% seroconversion (HI) 3 weeks post second priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 209
Time frame: Day 209
% seroconversion (HI) 1 week post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 223
Time frame: Day 223
% seroconversion (HI) 3 weeks post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 22
Time frame: Day 22
% seroconversion (HI) 3 weeks post first priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 43
Time frame: Day 43
% seroconversion (HI) 3 weeks post second priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 223
Time frame: Day 223
% seroconversion (HI) 3 weeks post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
19 secondary outcomes
Frequency and severity of solicited local and systemic adverse events (AEs)
Time frame: Day 1 through Day 7, Day 22 through Day 28, and Day 202 through 208
Frequency and severity of unsolicited AEs
Time frame: Day 1 through Day 43 and Day 202 through Day 223
Frequency and severity of serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI), and medically attended AEs (MAAEs)
Time frame: Day 1 through Day 382
GMT of HI antibodies against H5N8 strain - Persistence
Time frame: Day 202, Day 382
GMT of HI antibodies against H5N6 strain - Persistence
Time frame: Day 202
GMFI of HI antibodies against H5N8 strain - Persistence
Time frame: Day 202, Day 382
GMFI of HI antibodies against H5N6 strain - Persistence
Time frame: Day 202
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Persistence
Time frame: Day 202, Day 382
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Persistence
Time frame: Day 202
Percentages of subjects with seroconversion by HI against H5N8 strain - Persistence
Time frame: Day 202, Day 382
Percentages of subjects with seroconversion by HI against H5N6 strain - Persistence
Time frame: Day 202
GMT of microneutralization (MN) antibodies against H5N8 strain
Time frame: Day 1, Day 22, Day 43, Day 202, Day 223
GMT of MN antibodies against H5N6 strain
Time frame: Day 1, Day 43, Day 202, Day 223
GMFI of MN antibodies against H5N8 strain
Time frame: Day 22, Day 43, Day 202, Day 223
GMFI of MN antibodies against H5N6 strain
Time frame: Day 43, Day 202, Day 223
Percentages of subjects with MN titers ≥1:40 against H5N8 strain
Time frame: Day 1, Day 22, Day 43, Day 202, Day 223
Percentages of subjects with MN titers ≥1:40 against H5N6 strain
Time frame: Day 1, Day 43, Day 202, Day 223
Percentages of subjects with seroconversion by MN against H5N8 strain
Time frame: Day 22, Day 43, Day 202, Day 209, Day 223
Percentages of subjects with seroconversion by MN against H5N6 strain
Time frame: Day 43, Day 202, Day 209, Day 223
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Therapeutic Area Head study chair
Seqirus
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aH5N8c on Day 1, aH5N6c on Day 1 and aH5N8c on Day 22 in people with Influenza, Human and Infections, run by Seqirus 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 17 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 13 Dec 2024. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N8 strain - Day 1 (time frame: Day 1). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.