ClinicalTrials.gg
CompletedNCT03497845Updated Jul 14, 2020Results posted

Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59

A Phase 2 interventional study of VN and IN in Influenza A Virus, H5N1 Subtype, sponsored by Biomedical Advanced Research and Development Authority. Completed at 6 sites in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by Biomedical Advanced Research and Development Authority · Phase 2, Interventional, and Prevention

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Phase
Phase 2
Study type
Interventional
Enrollment
720
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 60 studies in Influenza in Birds with a site in United States — none open to participants now, 1 under way, 1 of them phase 3. Influenza in Birds · United States.

Enrollment
6th of 59
720 · median 100
Started
2018
with 6 others
Phase 2
18 of 60
none open now
Registered
52nd of 60
by date
Lead sponsor
2 of 60
Biomedical Advanced Research and Development Authority

Among the 60 studies in Influenza in Birds with a site in United States, this one is the 6th largest by enrollment of the 59 interventional ones that give a count, is one of 7 that started in 2018, is one of 18 in phase 2, and was the 52nd registered.

Influenza in Birds

96 studies on the registry are indexed under Influenza in Birds; 2 are open to participants now.

Browse Influenza in Birds studies →

Open to participants now

None of the 60 studies in Influenza in Birds with a site in United States is open now. The open studies under Influenza in Birds, anywhere →

Who these studies take

Of the 1 Influenza in Birds study recruiting now, 1 sets no upper age limit and none stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.

This study: 18 Years to 49 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 60 studies in Influenza in Birds with a site in United States as a file.
02

Study summary

The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains.

The study is designed to evaluate the safety and immunogenicity of vaccination strategies with homologous or antigenically distant heterologous H5 influenza virus vaccines administered with AS03 or MF59 adjuvant.

03

Conditions studied

  • Influenza A Virus, H5N1 Subtype

Browse trials for

Keywords

  • vaccine
  • adjuvant
  • Influenza in Birds
  • MF59
  • AS03
04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Is a male or nonpregnant female 18 to 49 years of age, inclusive, on Day 1 (first vaccination).
  2. Will avoid nonstudy vaccinations until 21 days after the last vaccination.
  3. Provides written prior to the initiation of any study-related procedures.
  4. Has a stable health status, as established by physical examination, vital sign measurements, and medical history.
  5. Has access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
  6. Is able to understand and comply with planned study procedures.
  7. Lives a reasonable distance from the site to be able to travel to and from the site for follow-up visits and agrees to go to the site for evaluation in the case of an adverse event.
  8. Agrees to stay in contact with the site for the duration of the study, has no current plans to move from the study area, and provides updated contact information as necessary.

Exclusion criteria

Exclusion Criteria:

  1. Has a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol-9, thimerosal, or chicken protein), or allergy to squalene-based adjuvants or has had severe reactions following previous immunizations with contemporary influenza virus vaccines.
  2. A woman who has a positive urine pregnancy test prior to vaccination in this study or a woman who is breastfeeding.
  3. A female of (a) who refuses to use an acceptable method of (b) from Day 1 (first vaccination) to end-of-study visit and, if sexually active, who has not used a reliable birth control method for at least 2 months prior to Day 1 (first vaccination).

    1. Female of childbearing potential is defined as post-onset menarche and premenopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: menopausal >1 year, tubal ligation >1 year, bilateral salpingo-oophorectomy, or hysterectomy.
    2. Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label, for example: abstinence from penile-vaginal intercourse; oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; male partner sterilization at least 6 months prior to the female Day 1 (first vaccination), and this male is the sole partner for that subject (The information on the male sterility can come from the site personnel's review of the subject's medical records or interview with the subject on her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).
  4. Is as a result of an underlying illness or treatment, or anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months prior to Day 1 (first vaccination).
  5. Has an active neoplastic disease or a history of any hematologic . A subject with superficial skin cancer who does not require intervention other than local excision is not excluded.
  6. Has long-term use (≥14 consecutive days) of including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within 1 month prior to screening. (Low-dose [≤800 mcg/day of beclomethasone dipropionate or equivalent] inhaled and topical steroids are allowed).
  7. Has a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.
  8. Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
  9. Has a neurological or psychiatric diagnosis, which, although stable, is judged by the investigator to render the potential subject unable or unlikely to comply with the protocol or to provide accurate safety reports.
  10. Has received immunoglobulin or other blood product (with the exception of Rho[D] immune globulin) within the 3 months prior to Day 1 (first vaccination).
  11. Has received any within 4 weeks or inactivated vaccines within 2 weeks prior to Day 1 (first vaccination). This includes seasonal influenza vaccines.
  12. Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. This includes potentially immune-mediated medical conditions such as Guillain-Barré syndrome, narcolepsy, current or history of or chronic inflammatory disease.
  13. Has a first-degree relative with narcolepsy.
  14. Has an acute illness, including body temperature greater than 100.4°F, at screening, immediately prior to each vaccination or, per subject report, within 3 days prior to each vaccination. Subjects with an acute illness can be rescheduled for a vaccination as long as the vaccination visit is within the visit window. Note that subjects may return for randomization following resolution of the acute illness as long as recruitment remains open and subjects are within 14 days of signing consent.
  15. Has a Grade 2 or greater (by US Food and Drug Administration toxicity grade) safety laboratory value at screening.
  16. Has received an experimental agent (vaccine, biologic, device, blood product, or medication) within 1 month prior to Day 1 (first vaccination) in this study or plans receipt of an experimental agent during the study period.
  17. Is participating or plans to participate in another interventional clinical study (either active or follow-up phase) during the study period.
  18. Has received an influenza H5 vaccine in the past or has a history of H5 influenza infection prior to enrollment.
  19. Has known , , or infection.
  20. Has a history of alcohol or drug abuse within 5 years prior to Day 1 (first vaccination).
  21. Has a >35 kg/m2.
  22. Has any condition that would, in the opinion of the investigator, place him or her at an unacceptable risk of injury or render him or her unable to meet the requirements of the protocol (including site of injection reactogenicity assessments).
  23. Is a first-degree relative of any person working on this study: site or sponsor.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
720 participants (actual)

Study arms

  • Experimental
    a VN with AS03 Adjuvant, then gf/WA with AS03 Adjuvant

    Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).

    Biological: VN · Biological: gf/WA · Biological: AS03 adjuvant

  • Experimental
    b IN with AS03 Adjuvant, then gf/WA with AS03 Adjuvant

    Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).

    Biological: IN · Biological: gf/WA · Biological: AS03 adjuvant

  • Experimental
    c dk/BANG with AS03 Adjuvant, then gf/WA with AS03 Adjuvant

    Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).

    Biological: dk/BANG · Biological: gf/WA · Biological: AS03 adjuvant

  • Experimental
    d gf/WA with AS03 Adjuvant, then IN with AS03 Adjuvant

    Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).

    Biological: IN · Biological: gf/WA · Biological: AS03 adjuvant

  • Experimental
    e dk/BANG with AS03 Adjuvant, then bhg/QL with AS03 Adjuvant

    Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).

    Biological: dk/BANG · Biological: bhg/QL · Biological: AS03 adjuvant

  • Experimental
    f gf/WA with AS03 Adjuvant, then bhg/QL with AS03 Adjuvant

    Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)

    Biological: gf/WA · Biological: bhg/QL · Biological: AS03 adjuvant

  • Experimental
    g VN with MF59 Adjuvant, then gf/WA with MF59 Adjuvant

    Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).

    Biological: VN · Biological: gf/WA · Biological: MF59 adjuvant

  • Experimental
    h IN with MF59 Adjuvant, then gf/WA with MF59 Adjuvant

    Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).

    Biological: IN · Biological: gf/WA · Biological: MF59 adjuvant

  • Experimental
    i dk/BANG with MF59 Adjuvant, then gf/WA with MF59 Adjuvant

    Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).

    Biological: dk/BANG · Biological: gf/WA · Biological: MF59 adjuvant

  • Experimental
    j gf/WA with MF59 Adjuvant, then IN with MF59 Adjuvant

    Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).

    Biological: IN · Biological: gf/WA · Biological: MF59 adjuvant

  • Experimental
    k dk/BANG with MF59 Adjuvant, then bhg/QL with MF59 Adjuvant

    Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22); followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).

    Biological: dk/BANG · Biological: bhg/QL · Biological: MF59 adjuvant

  • Experimental
    l gf/WA with MF59 Adjuvant, then bhg/QL with MF59 Adjuvant

    Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).

    Biological: gf/WA · Biological: bhg/QL · Biological: MF59 adjuvant

Interventions

  • BiologicalVN

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

    Also known as: A/Vietnam/1203/2004 vaccine antigen strain H5N1

  • BiologicalIN

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

    Also known as: A/Indonesia/05/2005 vaccine antigen strain H5N1

  • Biologicaldk/BANG

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

    Also known as: A/duck/Bangladesh/19097/2013 vaccine antigen strain H5N1

  • Biologicalgf/WA

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

    Also known as: A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8

  • Biologicalbhg/QL

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

    Also known as: A/barheaded goose/Qinghai Lake/1A/2005 vaccine antigen strain H5N1

  • BiologicalAS03 adjuvant

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

  • BiologicalMF59 adjuvant

    0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

06

What researchers measure

Primary outcomes

  1. Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series

    Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local reactogenicity symptoms. Subjects in A-D and G-J did not receive 3 doses

    Time frame: 8 days post-vaccination

  2. Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series

    Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited systemic reactogenicity symptoms Subjects in A-D and G-J did not receive 3 doses

    Time frame: 8 days post-vaccination

  3. Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series

    Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)

    Time frame: Day 43

  4. Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series

    Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)

    Time frame: Day 163

07

Results

Posted Jul 14, 2020

Participant flow

Participant flow — Overall Study
Milestonea VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantb IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantc dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantd gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvante dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantf gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantg VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanth IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanti dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvantj gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvantk dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvantl gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
Started605861605962596061596160
Completed554550503844515047534638
Not completed513111021188101461522

Outcome measures

PrimaryNumber of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series

Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local reactogenicity symptoms. Subjects in A-D and G-J did not receive 3 doses

Time frame:
8 days post-vaccination
Reported as:
Number · Events
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
Eventsa VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantb IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantc dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantd gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvante dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantf gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantg VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanth IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanti dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvantj gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvantk dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvantl gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
AEs in subjects who received Dose 1 : Mild433235372835182122272522
AEs in subjects who received Dose 1 : Moderate3564310101221
AEs in subjects who received Dose 1 : Severe001000000000
AEs in subjects who received Dose 2 : Mild272827232333161716181615
AEs in subjects who received Dose 2 : Moderate543353004223
AEs in subjects who received Dose 2 : Severe000000000000
AEs in Subjects who received Dose 3 : Mild————1717————106
AEs in Subjects who received Dose 3 : Moderate————53————10
AEs in Subjects who received Dose 3 : Severe————00————00
PrimaryNumber of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series

Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited systemic reactogenicity symptoms Subjects in A-D and G-J did not receive 3 doses

Time frame:
8 days post-vaccination
Reported as:
Number · Events
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
Eventsa VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantb IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantc dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantd gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvante dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantf gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantg VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanth IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanti dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvantj gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvantk dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvantl gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
AEs in subjects who received dose 1 : Mild454132432337292829213223
AEs in subjects who received dose 1 : Moderate61281961913266519
AEs in subjects who received dose 1 : Severe000000000000
AEs in subjects who received dose 2 : Mild3933224617401662441711
AEs in subjects who received dose 2 : Moderate1910720821403662
AEs in subjects who received dose 2 : Severe006000000000
AEs in subjects who received dose 3 : Mild————1932————119
AEs in subjects who received dose 3 : Moderate————1912————20
AEs in subjects who received dose 3 : Severe————11————00
PrimaryPercentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series

Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)

Time frame:
Day 43
Reported as:
Number · percentage of participants
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series
percentage of participantsa VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantb IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantc dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantd gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvante dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantf gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantg VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanth IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanti dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvantj gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvantk dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvantl gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
A/gyrfalcon/Washington/41088-6/2014 (H5N8) (gf/WA)47.2 (33.7 to 60.6)40.4 (27.0 to 53.7)38.9 (25.9 to 51.9)50.0 (36.4 to 63.6)12.5 (2.3 to 22.7)80.0 (68.3 to 91.7)15.7 (5.7 to 25.7)15.4 (5.6 to 25.2)37.3 (24.0 to 50.5)11.8 (2.9 to 20.6)6.5 (0.0 to 13.7)63.2 (47.8 to 78.5)
A/Indonesia/05/2005 (H5N1) (IN)13.2 (4.1 to 22.3)38.5 (25.0 to 51.7)11.1 (2.7 to 19.5)46.2 (32.6 to 59.7)32.5 (18.0 to 47.0)4.4 (0.0 to 10.5)0.0 (0.0 to 0.0)17.3 (7.0 to 27.6)3.9 (0.0 to 9.2)13.7 (4.3 to 23.2)10.9 (1.9 to 19.9)5.3 (0.0 to 12.4)
A/duck/Bangladesh/19097/2013 (H5N1) (dk/BANG)26.4 (14.5 to 38.3)25.0 (13.2 to 36.8)31.5 (19.1 to 43.9)32.7 (19.9 to 45.4)67.5 (53.0 to 82.0)15.6 (5.0 to 26.1)3.9 (0.0 to 9.2)9.6 (1.6 to 17.6)33.3 (20.4 to 46.3)13.7 (4.3 to 23.2)50.0 (35.6 to 64.4)13.2 (2.4 to 23.9)
A/Vietnam/1203/2004 (H5N1) (VN)75.5 (63.9 to 87.1)55.8 (42.3 to 69.3)44.4 (31.2 to 57.7)65.4 (52.5 to 78.3)37.5 (22.5 to 52.5)17.8 (6.6 to 28.9)39.2 (25.8 to 52.6)23.1 (11.6 to 34.5)33.3 (20.4 to 46.3)37.3 (24.0 to 50.5)26.1 (13.4 to 38.8)18.4 (6.1 to 30.7)
A/barheaded goose/QinghaiLake/1A/2005(H5N1)bhg/QL28.3 (16.2 to 40.4)19.2 (8.5 to 29.9)20.4 (9.6 to 31.1)34.6 (21.7 to 47.5)22.5 (9.6 to 35.4)2.2 (0.0 to 6.5)13.7 (4.3 to 23.2)13.5 (4.2 to 22.7)9.8 (1.6 to 18.0)3.9 (0.0 to 9.2)6.5 (0.0 to 13.7)2.6 (0.0 to 7.7)
PrimaryPercentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series

Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)

Time frame:
Day 163
Reported as:
Number · percentage of participants
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series
percentage of participantse dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantf gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantk dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvantl gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
A/gyrfalcon/Washington/41088-6/2014 (H5N8) (gf/WA)60.0 (44.8 to 75.2)82.2 (71.1 to 93.4)28.3 (15.2 to 41.4)52.6 (36.8 to 68.5)
A/Indonesia/05/2005 (H5N1) (IN)75.0 (61.6 to 88.4)57.8 (43.3 to 72.2)50.0 (35.6 to 64.4)15.8 (4.2 to 27.4)
A/duck/Bangladesh/19097/2013 (H5N1) (dk/BANG)90.0 (80.7 to 99.3)62.2 (48.1 to 76.4)63.0 (49.1 to 77.0)26.3 (12.3 to 40.3)
A/Vietnam/1203/2004 (H5N1) (VN)90.0 (80.7 to 99.3)80.0 (68.3 to 91.7)63.0 (49.1 to 77.0)60.5 (45.0 to 76.1)
A/barheaded goose/QinghaiLake/1A/2005(H5N1)bhg/QL72.5 (58.7 to 86.3)73.3 (60.4 to 86.3)45.7 (31.2 to 60.0)39.5 (23.9 to 55.0)

Adverse events

Collected over 262 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant0/60 (0%)1/60 (1.7%)46/60 (76.7%)
b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant0/58 (0%)2/58 (3.4%)45/58 (77.6%)
c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant0/61 (0%)1/61 (1.6%)44/61 (72.1%)
d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant0/60 (0%)0/60 (0%)43/60 (71.7%)
e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant1/59 (1.7%)2/59 (3.4%)47/59 (79.7%)
f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant0/62 (0%)0/62 (0%)47/62 (75.8%)
g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant0/59 (0%)2/59 (3.4%)40/59 (67.8%)
h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant0/60 (0%)1/60 (1.7%)36/60 (60%)
i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant0/61 (0%)0/61 (0%)40/61 (65.6%)
j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant0/59 (0%)0/59 (0%)41/59 (69.5%)
k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant0/61 (0%)4/61 (6.6%)45/61 (73.8%)
l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant0/60 (0%)1/60 (1.7%)42/60 (70%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
Eventa VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantb IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantc dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantd gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvante dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantf gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantg VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanth IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanti dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvantj gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvantk dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvantl gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
GastroenteritisInfections and infestations0/601/580/610/600/590/620/590/600/610/590/610/60
Ankyloglossia, congenitalCongenital, familial and genetic disorders0/601/580/610/600/590/620/590/600/610/590/610/60
Gun Shot WoundInjury, poisoning and procedural complications0/600/580/610/601/590/620/590/600/610/590/610/60
Acute AppendicitisInfections and infestations0/600/580/610/601/590/620/590/600/610/590/610/60
Major depressionPsychiatric disorders0/600/580/610/600/590/621/590/600/610/590/610/60
Suicidal ideationPsychiatric disorders0/600/580/610/600/590/621/590/600/610/590/610/60
AngioedemaSkin and subcutaneous tissue disorders1/600/580/610/600/590/620/590/600/610/590/610/60
Extrasystoles/Ventricluar Premature ContractionsCardiac disorders0/600/580/610/600/590/620/590/600/610/590/611/60
Bartholin's AbscessInfections and infestations0/600/580/610/600/590/620/591/600/610/590/610/60
Major Depressive Episode with Suicidal IntentPsychiatric disorders0/600/580/610/600/590/620/590/600/610/591/610/60
Most frequent other events
Showing 10 of 16
Most frequent other events
Eventa VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantb IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantc dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantd gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvante dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantf gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantg VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanth IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanti dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvantj gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvantk dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvantl gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant
Injection site painGeneral disorders42/6035/5836/6135/6035/5936/6222/5926/6025/6128/5933/6125/60
MyalgiaMusculoskeletal and connective tissue disorders17/6013/5814/6120/6013/5926/628/594/6014/615/5911/6110/60
HeadacheNervous system disorders21/6016/588/6117/6010/5922/6210/5911/6012/617/5918/6111/60
FatigueGeneral disorders15/6014/5812/6114/609/5916/627/596/6012/618/5910/616/60
ChillsGeneral disorders10/607/586/6112/607/5914/624/590/600/612/592/613/60
NauseaGastrointestinal disorders9/606/587/6110/6010/5910/625/593/603/613/595/616/60
Injection site swellingGeneral disorders5/602/586/613/605/5910/620/590/600/610/590/610/60
ArthralgiaMusculoskeletal and connective tissue disorders4/604/584/614/604/5910/622/590/603/613/594/613/60
DiarrheaGastrointestinal disorders4/605/585/617/609/599/627/593/605/615/597/615/60
Injection site erythemaGeneral disorders5/604/585/612/603/594/621/591/601/611/590/613/60

Baseline characteristics

Age, Customized
Age, Customized(Participants)a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantb IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantc dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantd gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvante dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantf gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantg VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanth IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanti dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvantj gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvantk dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvantl gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 AdjuvantTotal
Age of Participants — 18-<30 years old232326262421241834182225284
Age of Participants — 30-<40 years old171523172117152213261419219
Age of Participants — 40-49 years old202012171424202014152516217
Sex: Female, Male
Sex: Female, Male(Participants)a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantb IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantc dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantd gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvante dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantf gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantg VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanth IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanti dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvantj gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvantk dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvantl gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 AdjuvantTotal
Female373235403831433142283538430
Male232626202131162919312622290
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantb IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantc dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantd gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvante dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantf gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantg VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanth IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanti dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvantj gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvantk dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvantl gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 AdjuvantTotal
Race of Participants — White514242494247444845414242535
Race of Participants — Black or African American81014513111061211148122
Race of Participants — Asian11111222241119
Race of Participants — American Indian or Alaska Native0000100000001
Race of Participants — Native Hawaiian or Pacific Islander0000000000000
Race of Participants — Multiracial05452224234740
Race of Participants — Other0000001000023
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantb IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantc dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantd gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvante dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantf gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantg VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanth IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanti dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvantj gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvantk dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvantl gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 AdjuvantTotal
Ethnicity of Participants — Hispanic or Latino47656577547568
Ethnicity of Participants — Not Hispanic or Latino565155555357525356555455652
Body Mass Index (BMI) (kg/m^2)
Body Mass Index (BMI) (kg/m^2)(kg/m^2)a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantb IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantc dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvantd gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvante dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantf gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvantg VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanth IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvanti dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvantj gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvantk dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvantl gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 AdjuvantTotal
Mean26.637 ± 4.412326.750 ± 5.328727.561 ± 5.107926.840 ± 4.486826.458 ± 4.447626.495 ± 4.246126.798 ± 4.679427.297 ± 4.546026.457 ± 4.788126.824 ± 3.994526.867 ± 4.030026.268 ± 4.762026.771 ± 4.5691
08

Study locations

6 sites
  • Optimal Research
    San Diego, California 92108, United States
  • Optimal Research
    Peoria, Illinois 61614, United States
  • Johnson County Clin-Trials
    Lenexa, Kansas 66219, United States
  • Central Kentucky Research Associates Inc
    Lexington, Kentucky 40509, United States
  • Optimal Research
    Rockville, Maryland 20850, United States
  • Rochester Clinical Research, Inc
    Rochester, New York 14609, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Nov 2019, 20 months.

Results were first posted in Jul 2020, 7 months after primary completion.

Of 11 phase 2 interventional studies under Influenza in Birds, half reached primary completion within 17 months of starting (the median); a quarter within 4 and three quarters within 19. This study's 20 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2018
First posted
Apr 13, 2018
StartActual
Mar 15, 2018
Primary completionActual
Nov 19, 2019
CompletionActual
Nov 19, 2019
Results first posted
Jul 14, 2020
Last update
Jul 14, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03497845
Lead sponsor
Biomedical Advanced Research and Development Authority
Responsible party
Sponsor
First posted
Apr 13, 2018
Start date
Mar 15, 2018
Primary completion
Nov 19, 2019
Completion
Nov 19, 2019
Results posted
Jul 14, 2020
Last update
Jul 14, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: AS03 adjuvant · MF59

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