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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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.
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.
96 studies on the registry are indexed under Influenza in Birds; 2 are open to participants now.
Browse Influenza in Birds studies →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 →
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.
60 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 39 · Phase 2 25 · Phase 3 2
First in 2005; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 720 is above the median of 150 across 88 interventional studies indexed under Influenza in Birds.
Median enrollment 100 across the 59 interventional studies, 250 across the 1 observational. Of the 59 that completed or were terminated, 18 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
16 of 60 have an industry lead sponsor. The 10 most frequent:
Biomedical Advanced Research and Development Authority is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Biomedical Advanced Research and Development Authority has 2 studies filed under Influenza in Birds — fewer than ten, so there is no comparison to draw.
1 of the studies in Influenza in Birds with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07496450Phase 3ModernaTX, Inc.A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults | 2027-01-28 |
Add it to your calendar (.ics) → With an account.
Among the 60 studies in Influenza in Birds with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Exclusion Criteria:
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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 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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
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
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
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
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
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
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
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Also known as: A/Vietnam/1203/2004 vaccine antigen strain H5N1
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Also known as: A/Indonesia/05/2005 vaccine antigen strain H5N1
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Also known as: A/duck/Bangladesh/19097/2013 vaccine antigen strain H5N1
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Also known as: A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8
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
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
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
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
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
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
| Milestone | a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant | e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant | k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 60 | 58 | 61 | 60 | 59 | 62 | 59 | 60 | 61 | 59 | 61 | 60 |
| Completed | 55 | 45 | 50 | 50 | 38 | 44 | 51 | 50 | 47 | 53 | 46 | 38 |
| Not completed | 5 | 13 | 11 | 10 | 21 | 18 | 8 | 10 | 14 | 6 | 15 | 22 |
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
| Events | a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant | e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant | k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AEs in subjects who received Dose 1 : Mild | 43 | 32 | 35 | 37 | 28 | 35 | 18 | 21 | 22 | 27 | 25 | 22 |
| AEs in subjects who received Dose 1 : Moderate | 3 | 5 | 6 | 4 | 3 | 10 | 1 | 0 | 1 | 2 | 2 | 1 |
| AEs in subjects who received Dose 1 : Severe | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AEs in subjects who received Dose 2 : Mild | 27 | 28 | 27 | 23 | 23 | 33 | 16 | 17 | 16 | 18 | 16 | 15 |
| AEs in subjects who received Dose 2 : Moderate | 5 | 4 | 3 | 3 | 5 | 3 | 0 | 0 | 4 | 2 | 2 | 3 |
| AEs in subjects who received Dose 2 : Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AEs in Subjects who received Dose 3 : Mild | — | — | — | — | 17 | 17 | — | — | — | — | 10 | 6 |
| AEs in Subjects who received Dose 3 : Moderate | — | — | — | — | 5 | 3 | — | — | — | — | 1 | 0 |
| AEs in Subjects who received Dose 3 : Severe | — | — | — | — | 0 | 0 | — | — | — | — | 0 | 0 |
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
| Events | a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant | e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant | k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AEs in subjects who received dose 1 : Mild | 45 | 41 | 32 | 43 | 23 | 37 | 29 | 28 | 29 | 21 | 32 | 23 |
| AEs in subjects who received dose 1 : Moderate | 6 | 12 | 8 | 19 | 6 | 19 | 13 | 2 | 6 | 6 | 5 | 19 |
| AEs in subjects who received dose 1 : Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AEs in subjects who received dose 2 : Mild | 39 | 33 | 22 | 46 | 17 | 40 | 16 | 6 | 24 | 4 | 17 | 11 |
| AEs in subjects who received dose 2 : Moderate | 19 | 10 | 7 | 20 | 8 | 21 | 4 | 0 | 3 | 6 | 6 | 2 |
| AEs in subjects who received dose 2 : Severe | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AEs in subjects who received dose 3 : Mild | — | — | — | — | 19 | 32 | — | — | — | — | 11 | 9 |
| AEs in subjects who received dose 3 : Moderate | — | — | — | — | 19 | 12 | — | — | — | — | 2 | 0 |
| AEs in subjects who received dose 3 : Severe | — | — | — | — | 1 | 1 | — | — | — | — | 0 | 0 |
Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)
| percentage of participants | a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant | e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant | k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | l 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/QL | 28.3 (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) |
Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)
| percentage of participants | e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | l 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/QL | 72.5 (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) |
Collected over 262 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | 0/60 (0%) | 1/60 (1.7%) | 46/60 (76.7%) |
| b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | 0/58 (0%) | 2/58 (3.4%) | 45/58 (77.6%) |
| c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | 0/61 (0%) | 1/61 (1.6%) | 44/61 (72.1%) |
| d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant | 0/60 (0%) | 0/60 (0%) | 43/60 (71.7%) |
| e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | 1/59 (1.7%) | 2/59 (3.4%) | 47/59 (79.7%) |
| f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | 0/62 (0%) | 0/62 (0%) | 47/62 (75.8%) |
| g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | 0/59 (0%) | 2/59 (3.4%) | 40/59 (67.8%) |
| h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | 0/60 (0%) | 1/60 (1.7%) | 36/60 (60%) |
| i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | 0/61 (0%) | 0/61 (0%) | 40/61 (65.6%) |
| j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant | 0/59 (0%) | 0/59 (0%) | 41/59 (69.5%) |
| k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | 0/61 (0%) | 4/61 (6.6%) | 45/61 (73.8%) |
| l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | 0/60 (0%) | 1/60 (1.7%) | 42/60 (70%) |
| Event | a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant | e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant | k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| GastroenteritisInfections and infestations | 0/60 | 1/58 | 0/61 | 0/60 | 0/59 | 0/62 | 0/59 | 0/60 | 0/61 | 0/59 | 0/61 | 0/60 |
| Ankyloglossia, congenitalCongenital, familial and genetic disorders | 0/60 | 1/58 | 0/61 | 0/60 | 0/59 | 0/62 | 0/59 | 0/60 | 0/61 | 0/59 | 0/61 | 0/60 |
| Gun Shot WoundInjury, poisoning and procedural complications | 0/60 | 0/58 | 0/61 | 0/60 | 1/59 | 0/62 | 0/59 | 0/60 | 0/61 | 0/59 | 0/61 | 0/60 |
| Acute AppendicitisInfections and infestations | 0/60 | 0/58 | 0/61 | 0/60 | 1/59 | 0/62 | 0/59 | 0/60 | 0/61 | 0/59 | 0/61 | 0/60 |
| Major depressionPsychiatric disorders | 0/60 | 0/58 | 0/61 | 0/60 | 0/59 | 0/62 | 1/59 | 0/60 | 0/61 | 0/59 | 0/61 | 0/60 |
| Suicidal ideationPsychiatric disorders | 0/60 | 0/58 | 0/61 | 0/60 | 0/59 | 0/62 | 1/59 | 0/60 | 0/61 | 0/59 | 0/61 | 0/60 |
| AngioedemaSkin and subcutaneous tissue disorders | 1/60 | 0/58 | 0/61 | 0/60 | 0/59 | 0/62 | 0/59 | 0/60 | 0/61 | 0/59 | 0/61 | 0/60 |
| Extrasystoles/Ventricluar Premature ContractionsCardiac disorders | 0/60 | 0/58 | 0/61 | 0/60 | 0/59 | 0/62 | 0/59 | 0/60 | 0/61 | 0/59 | 0/61 | 1/60 |
| Bartholin's AbscessInfections and infestations | 0/60 | 0/58 | 0/61 | 0/60 | 0/59 | 0/62 | 0/59 | 1/60 | 0/61 | 0/59 | 0/61 | 0/60 |
| Major Depressive Episode with Suicidal IntentPsychiatric disorders | 0/60 | 0/58 | 0/61 | 0/60 | 0/59 | 0/62 | 0/59 | 0/60 | 0/61 | 0/59 | 1/61 | 0/60 |
| Event | a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant | e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant | k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Injection site painGeneral disorders | 42/60 | 35/58 | 36/61 | 35/60 | 35/59 | 36/62 | 22/59 | 26/60 | 25/61 | 28/59 | 33/61 | 25/60 |
| MyalgiaMusculoskeletal and connective tissue disorders | 17/60 | 13/58 | 14/61 | 20/60 | 13/59 | 26/62 | 8/59 | 4/60 | 14/61 | 5/59 | 11/61 | 10/60 |
| HeadacheNervous system disorders | 21/60 | 16/58 | 8/61 | 17/60 | 10/59 | 22/62 | 10/59 | 11/60 | 12/61 | 7/59 | 18/61 | 11/60 |
| FatigueGeneral disorders | 15/60 | 14/58 | 12/61 | 14/60 | 9/59 | 16/62 | 7/59 | 6/60 | 12/61 | 8/59 | 10/61 | 6/60 |
| ChillsGeneral disorders | 10/60 | 7/58 | 6/61 | 12/60 | 7/59 | 14/62 | 4/59 | 0/60 | 0/61 | 2/59 | 2/61 | 3/60 |
| NauseaGastrointestinal disorders | 9/60 | 6/58 | 7/61 | 10/60 | 10/59 | 10/62 | 5/59 | 3/60 | 3/61 | 3/59 | 5/61 | 6/60 |
| Injection site swellingGeneral disorders | 5/60 | 2/58 | 6/61 | 3/60 | 5/59 | 10/62 | 0/59 | 0/60 | 0/61 | 0/59 | 0/61 | 0/60 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/60 | 4/58 | 4/61 | 4/60 | 4/59 | 10/62 | 2/59 | 0/60 | 3/61 | 3/59 | 4/61 | 3/60 |
| DiarrheaGastrointestinal disorders | 4/60 | 5/58 | 5/61 | 7/60 | 9/59 | 9/62 | 7/59 | 3/60 | 5/61 | 5/59 | 7/61 | 5/60 |
| Injection site erythemaGeneral disorders | 5/60 | 4/58 | 5/61 | 2/60 | 3/59 | 4/62 | 1/59 | 1/60 | 1/61 | 1/59 | 0/61 | 3/60 |
| Age, Customized(Participants) | a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant | e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant | k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age of Participants — 18-<30 years old | 23 | 23 | 26 | 26 | 24 | 21 | 24 | 18 | 34 | 18 | 22 | 25 | 284 |
| Age of Participants — 30-<40 years old | 17 | 15 | 23 | 17 | 21 | 17 | 15 | 22 | 13 | 26 | 14 | 19 | 219 |
| Age of Participants — 40-49 years old | 20 | 20 | 12 | 17 | 14 | 24 | 20 | 20 | 14 | 15 | 25 | 16 | 217 |
| Sex: Female, Male(Participants) | a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant | e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant | k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 37 | 32 | 35 | 40 | 38 | 31 | 43 | 31 | 42 | 28 | 35 | 38 | 430 |
| Male | 23 | 26 | 26 | 20 | 21 | 31 | 16 | 29 | 19 | 31 | 26 | 22 | 290 |
| Race/Ethnicity, Customized(Participants) | a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant | e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant | k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Race of Participants — White | 51 | 42 | 42 | 49 | 42 | 47 | 44 | 48 | 45 | 41 | 42 | 42 | 535 |
| Race of Participants — Black or African American | 8 | 10 | 14 | 5 | 13 | 11 | 10 | 6 | 12 | 11 | 14 | 8 | 122 |
| Race of Participants — Asian | 1 | 1 | 1 | 1 | 1 | 2 | 2 | 2 | 2 | 4 | 1 | 1 | 19 |
| Race of Participants — American Indian or Alaska Native | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Race of Participants — Native Hawaiian or Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race of Participants — Multiracial | 0 | 5 | 4 | 5 | 2 | 2 | 2 | 4 | 2 | 3 | 4 | 7 | 40 |
| Race of Participants — Other | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 3 |
| Race/Ethnicity, Customized(Participants) | a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant | e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant | k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ethnicity of Participants — Hispanic or Latino | 4 | 7 | 6 | 5 | 6 | 5 | 7 | 7 | 5 | 4 | 7 | 5 | 68 |
| Ethnicity of Participants — Not Hispanic or Latino | 56 | 51 | 55 | 55 | 53 | 57 | 52 | 53 | 56 | 55 | 54 | 55 | 652 |
| Body Mass Index (BMI) (kg/m^2)(kg/m^2) | a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant | d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant | e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant | g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant | j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant | k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 26.637 ± 4.4123 | 26.750 ± 5.3287 | 27.561 ± 5.1079 | 26.840 ± 4.4868 | 26.458 ± 4.4476 | 26.495 ± 4.2461 | 26.798 ± 4.6794 | 27.297 ± 4.5460 | 26.457 ± 4.7881 | 26.824 ± 3.9945 | 26.867 ± 4.0300 | 26.268 ± 4.7620 | 26.771 ± 4.5691 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: AS03 adjuvant · MF59
Biomedical Advanced Research and Development Authority