A Phase 2 interventional study of 3.75 ug Panblok H7 and 7.5 ug Panblok H7 in Influenza, Human, sponsored by Biomedical Advanced Research and Development Authority. Completed at 4 sites in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-06.
Sponsored by Biomedical Advanced Research and Development Authority · Phase 2, Interventional, and Prevention
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Among 22 studies testing MF59 in Influenza, Human — 3 open to participants now, 3 under way, 1 of them phase 3. MF59 · Influenza, Human.
Among the 22 studies testing MF59 in Influenza, Human, this one is the 15th largest by enrollment, is one of 4 that started in 2017, is one of 4 in phase 2, and was the 15th registered.
2,358 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
Browse Influenza, Human studies →3 of the 22 studies testing MF59 in Influenza, Human are open now, in 1 country. Recruiting first, the newest first:
Korea University Guro Hospital · Sites in Korea, Republic of
Ages 19+ · Healthy volunteers
Asan Medical Center · Sites in Korea, Republic of
Ages 19+
National Taiwan University Hospital
Ages 50+
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 121 Influenza, Human studies recruiting now, 66 (55%) set no upper age limit and 45 (37%) stop at 75 or younger; 33 take children under 18; 67 take 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.
22 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 4 · Phase 2 8 · Phase 3 10 · Phase 4 3
First in 2006; this study’s year is marked. 4 started in 2017.
This study's enrollment of 366 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Median enrollment 549 across the 22 interventional studies. Of the 19 that completed or were terminated, 10 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 22 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 3 studies filed under Influenza, Human — fewer than ten, so there is no comparison to draw.
2 of the studies testing MF59 in Influenza, Human that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07485855Phase 3Asan Medical CenterInfluenza Vaccination Strategy for Patients With Hematologic Malignancy | 2027-04-30 |
| NCT07126652National Taiwan University HospitalSerological Responses to Adjuvanted Versus Non-adjuvanted Influenza Vaccines Among People With HIV: a Randomized Clinical Trial | 2026-12-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 22 studies testing MF59 in Influenza, Human, 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 safety and ability of a Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated by 28 days. Three different antigen dose levels of Panblok H7 will be tested.
This is a randomized, double-blinded, phase 2 study to assess safety and immunogenicity of Panblok H7 vaccine at three antigen dose levels (3.75, 7.5, and 15 μg) adjuvanted with AS03 or MF59. The main purpose of this study is to assess the safety and ability of the recombinant Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated by 28 days in healthy males and nonpregnant females, aged 18 to 49 years, inclusive. The expected study duration is approximately 13.5 months per participant.
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:
Women who are pregnant or breast feeding. Women of must have a negative urine pregnancy test at screening and within 24 hours prior to each vaccination.
Women of childbearing potential are defined as postmenarcheal and premenopausal females capable of becoming pregnant. This does not include females who meet any of the following conditions: menopausal >12 months, tubal ligation >12 months, bilateral salpingo-oophorectomy, or hysterectomy.
Women of childbearing potential who refuse to use an acceptable method of from screening to Day 50 (Visit 7) or, if sexually active with a male partner, who have not used a reliable birth control method during the 2 months prior to screening.
Adequate contraception is defined as a contraceptive method with a 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 participant's Screening Visit, and this male is the sole partner for that participant (the information on the male partner's sterility can come from the site personnel's review of the participant medical records or interview with the participant 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).
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 plus AS03
Biological: 3.75 ug Panblok H7 · Biological: AS03
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with AS03
Biological: 7.5 ug Panblok H7 · Biological: AS03
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with AS03
Biological: 15 ug Panblok H7 · Biological: AS03
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 adjuvanted with MF59
Biological: 3.75 ug Panblok H7 · Biological: MF59
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with MF59
Biological: 7.5 ug Panblok H7 · Biological: MF59
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with MF59
Biological: 15 ug Panblok H7 · Biological: MF59
0.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL.
Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL.
Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL.
0.5 mL MF59 (39 mg squalene/mL ) adjuvant.
0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant AS03
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain
Time frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant AS03
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills.
Time frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant MF59
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain
Time frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant MF59
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills.
Time frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Time frame: Day 50
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Time frame: Day 50
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Time frame: Day 50
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Time frame: Day 50
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant AS03
Count of participants who experienced at least one serious adverse event
Time frame: Day 1 through Day 394
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant MF59
Count of participants who experienced at least one serious adverse event
Time frame: Day 1 through Day 394
Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant AS03
Count of participants who experienced at least one adverse event that requires a visit to medical personnel, including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason occurring post-vaccination.
Time frame: Day 1 through Day 394
Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant MF59
Count of participants who experienced at least one adverse event that requires a visit to medical personnel, including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason occurring post-vaccination.
Time frame: Day 1 through Day 394
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant AS03
Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination
Time frame: Day 1 through Day 394
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant MF59
Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination
Time frame: Day 1 through Day 394
Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant AS03
Count of participants who experienced at least one unsolicited adverse event (i.e. adverse events not included in the solicited local and systemic adverse event list nor considered a serious AE, MAAE or PIMMC ) that occur post-vaccination.
Time frame: Day 1 through Day 53, which is the upper window of the Day 50 visit
Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant MF59
Count of participants who experienced at least one unsolicited adverse event (i.e. adverse events not included in the solicited local and systemic adverse event list nor considered a serious AE, MAAE or PIMMC) that occur post-vaccination.
Time frame: Day 1 through Day 50
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Time frame: Day 50
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Time frame: Day 50
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Time frame: Day 50
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Time frame: Screening and Days 29, 50, 121 and 212
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Time frame: Day 50
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Days 29, 50, 121, and 212
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Time frame: Screening and Days 29, 50, 121 and 212
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Time frame: Day 50
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Time frame: Screening and Days 29, 50, 121 and 212
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Time frame: Day 50
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Time frame: Screening and Days 29, 50, 121 and 212
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Time frame: Day 50
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Time frame: Screening, Day 29, Day 121, Day 212
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Time frame: Screening, Day 29, Day 121, Day 212
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Time frame: Screening, Day 29, Day 121, Day 212
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Time frame: Screening, Day 29, Day 121, Day 212
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Day 29, Day 50, Day 121, Day 212
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Day 29, Day 50, Day 121, Day 212
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Day 29, Day 50, Day 121, Day 212
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Day 29, Day 50, Day 121, Day 212
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Day 29, Day 50, Day 121, Day 212
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Day 29, Day 50, Day 121, Day 212
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Day 29, Day 50, Day 121, Day 212
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Time frame: Day 50
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Serum MN antibody titers against the H7 antigen (protein) contained in the vaccine. A higher MN titer means a better immune response to the vaccine.
Time frame: Screening and Days 29, 50, 121 and 212
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Time frame: Screening and Days 29, 50, 121 and 212
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Time frame: Screening and Days 29, 50, 121 and 212
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Time frame: Screening and Days 29, 50, 121 and 212
| Milestone | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|---|---|---|
| Started | 62 | 60 | 62 | 61 | 60 | 61 |
| Completed | 55 | 54 | 55 | 54 | 56 | 57 |
| Not completed | 7 | 6 | 7 | 7 | 4 | 4 |
| Withdrew: Lost to follow-up | 5 | 4 | 5 | 5 | 4 | 3 |
| Withdrew: Withdrawal by subject | 2 | 2 | 2 | 1 | 0 | 1 |
| Withdrew: Barda regulatory agency or irb decision | 0 | 0 | 0 | 1 | 0 | 0 |
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant AS03 | 42 | 44 | 36 |
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant AS03 | 25 | 28 | 27 |
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant MF59 | 37 | 30 | 29 |
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant MF59 | 27 | 24 | 28 |
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03 | 53 | 53 | 56 |
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59 | 47 | 47 | 48 |
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03 | 48 | 52 | 55 |
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59 | 37 | 35 | 47 |
Count of participants who experienced at least one serious adverse event
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant AS03 | 3 | 1 | 3 |
Count of participants who experienced at least one serious adverse event
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant MF59 | 1 | 2 | 0 |
Count of participants who experienced at least one adverse event that requires a visit to medical personnel, including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason occurring post-vaccination.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant AS03 | 11 | 8 | 13 |
Count of participants who experienced at least one adverse event that requires a visit to medical personnel, including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason occurring post-vaccination.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant MF59 | 9 | 16 | 10 |
Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant AS03 | 0 | 0 | 0 |
Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant MF59 | 0 | 0 | 0 |
Count of participants who experienced at least one unsolicited adverse event (i.e. adverse events not included in the solicited local and systemic adverse event list nor considered a serious AE, MAAE or PIMMC ) that occur post-vaccination.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant AS03 | 24 | 25 | 22 |
Count of participants who experienced at least one unsolicited adverse event (i.e. adverse events not included in the solicited local and systemic adverse event list nor considered a serious AE, MAAE or PIMMC) that occur post-vaccination.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant MF59 | 24 | 24 | 21 |
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03 | 55 | 55 | 58 |
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59 | 38 | 36 | 47 |
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03 | 50 | 54 | 57 |
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
| Titers | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Screening | 5.1 (5.0 to 5.2) | 5.3 (5.0 to 5.7) | 5.5 (5.1 to 5.9) |
| Visit 4/Day 29 | 8.7 (7 to 10.8) | 12.3 (9.4 to 16) | 12.4 (9.2 to 16.8) |
| Visit 7/Day 50 | 297.1 (216.5 to 407.7) | 438.3 (329.4 to 583) | 505.9 (399.7 to 640.2) |
| Visit 8/Day 121 | 58.8 (43.9 to 78.8) | 73 (55.5 to 96) | 90 (70.2 to 115.3) |
| Visit 9/Day 212 | 21.2 (15.6 to 28.8) | 21.6 (16.2 to 28.7) | 26 (18.9 to 35.7) |
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59 | 48 | 48 | 48 |
The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Visit 4/Day 29 | 0 | 0 | 1 |
| Visit 7/Day 50 | 51 | 50 | 54 |
| Visit 8/Day 121 | 34 | 40 | 44 |
| Visit 9/Day 212 | 22 | 25 | 28 |
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
| Titers | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Screening | 5.1 (5 to 5.2) | 5.5 (5 to 6.1) | 5.1 (5 to 5.2) |
| Visit 4/Day 29 | 6.1 (5.1 to 7.3) | 6.6 (5.7 to 7.7) | 6.4 (5.6 to 7.3) |
| Visit 7/Day 50 | 76.3 (55.9 to 104) | 106.5 (74.1 to 153) | 130.6 (93.1 to 183.2) |
| Visit 8/Day 121 | 18.1 (13.6 to 24.1) | 20.7 (14.9 to 28.8) | 33.2 (25.1 to 43.9) |
| Visit 9/Day 212 | 6.8 (6 to 7.7) | 8.9 (7.1 to 11.1) | 11.4 (8.7 to 15) |
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
| Titers | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59 | 75.4 (55.6 to 102.4) | 103 (72.1 to 147.2) | 124.3 (87.9 to 175.8) |
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
| Titers | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Screening | 5 (5 to 5) | 5.2 (4.9 to 5.6) | 5.2 (5 to 5.4) |
| Visit 4/Day 29 | 5.9 (5.2 to 6.7) | 8.3 (6.7 to 10.3) | 8.4 (6.6 to 10.7) |
| Visit 7/Day 50 | 170.2 (119.9 to 241.7) | 302 (218.9 to 416.7) | 316.7 (246.2 to 407.4) |
| Visit 8/Day 121 | 45.2 (33.4 to 61.1) | 57.7 (42.5 to 78.4) | 69.7 (53.1 to 91.6) |
| Visit 9/Day 212 | 25 (18.3 to 34.2) | 28.1 (20.1 to 39.2) | 32.9 (24.4 to 44.4) |
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
| Titers | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03 | 163.8 (115.7 to 231.9) | 274.9 (195.3 to 386.9) | 313.1 (243.1 to 403.1) |
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
| Titers | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Screening | 5.1 (5 to 5.2) | 5.1 (5 to 5.2) | 5.3 (4.8 to 5.8) |
| Visit 4/Day 29 | 5.7 (5.1 to 6.3) | 5.6 (5.1 to 6.1) | 5.6 (5.2 to 6.1) |
| Visit 7/Day 50 | 47.6 (33.7 to 67.1) | 60.5 (40.5 to 90.4) | 74.5 (53.3 to 104) |
| Visit 8/Day 121 | 13 (10.2 to 16.6) | 15.1 (11.2 to 20.4) | 20.9 (15.6 to 27.8) |
| Visit 9/Day 212 | 7.8 (6.7 to 9.1) | 11.3 (8.6 to 14.8) | 13.6 (10.1 to 18.2) |
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
| Titers | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59 | 47.4 (33.8 to 66.5) | 58.6 (39.4 to 87.2) | 71.1 (50.6 to 100) |
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Screening | 0 | 0 | 0 |
| Visit 4/Day 29 | 7 | 10 | 13 |
| Visit 8/Day 121 | 40 | 45 | 47 |
| Visit 9/Day 212 | 21 | 19 | 23 |
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Screening | 0 | 0 | 0 |
| Visit 4/Day 29 | 1 | 3 | 0 |
| Visit 8/Day 121 | 19 | 24 | 34 |
| Visit 9/Day 212 | 1 | 4 | 7 |
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Screening | 0 | 0 | 0 |
| Visit 4/Day 29 | 2 | 5 | 4 |
| Visit 8/Day 121 | 37 | 40 | 45 |
| Visit 9/Day 212 | 22 | 22 | 26 |
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Screening | 0 | 0 | 1 |
| Visit 4/Day 29 | 1 | 0 | 0 |
| Visit 8/Day 121 | 10 | 15 | 22 |
| Visit 9/Day 212 | 1 | 8 | 11 |
The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Visit 4/Day 29 | 7 | 10 | 12 |
| Visit 7/Day 50 | 53 | 53 | 56 |
| Visit 8/Day 121 | 40 | 45 | 47 |
| Visit 9/Day 212 | 21 | 19 | 23 |
The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Visit 4/Day 29 | 1 | 2 | 0 |
| Visit 7/Day 50 | 47 | 47 | 48 |
| Visit 8/Day 121 | 19 | 23 | 34 |
| Visit 9/Day 212 | 1 | 4 | 7 |
The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Visit 4/Day 29 | 2 | 5 | 4 |
| Visit 7/Day 50 | 48 | 52 | 55 |
| Visit 8/Day 121 | 37 | 39 | 45 |
| Visit 9/Day 212 | 22 | 22 | 26 |
The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Visit 4/Day 29 | 1 | 0 | 0 |
| Visit 7/Day 50 | 37 | 35 | 47 |
| Visit 8/Day 121 | 10 | 15 | 21 |
| Visit 9/Day 212 | 1 | 8 | 11 |
The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Visit 4/Day 29 | 0 | 0 | 0 |
| Visit 7/Day 50 | 40 | 39 | 44 |
| Visit 8/Day 121 | 11 | 14 | 21 |
| Visit 9/Day 212 | 2 | 4 | 11 |
The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.
| Participants | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Visit 4/Day 29 | 0 | 2 | 7 |
| Visit 7/Day 50 | 53 | 53 | 56 |
| Visit 8/Day 121 | 38 | 43 | 47 |
| Visit 9/Day 212 | 25 | 28 | 34 |
The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.
| Participants | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Visit 4/Day 29 | 1 | 1 | 0 |
| Visit 7/Day 50 | 46 | 44 | 47 |
| Visit 8/Day 121 | 11 | 21 | 27 |
| Visit 9/Day 212 | 3 | 6 | 15 |
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
| Titers | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03 | 276.3 (200.1 to 381.5) | 400.7 (291.9 to 550.1) | 489.1 (383 to 624.5) |
Serum MN antibody titers against the H7 antigen (protein) contained in the vaccine. A higher MN titer means a better immune response to the vaccine.
| Titers | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Screening | 5.0 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) |
| Visit 4/Day 29 | 5.3 (5 to 5.5) | 6.2 (5.6 to 6.9) | 6.3 (5.5 to 7.2) |
| Visit 7/Day 50 | 201.2 (147.4 to 274.6) | 274.3 (197.4 to 381.2) | 286.3 (218.1 to 375.7) |
| Visit 8/Day 121 | 51.4 (40.8 to 64.7) | 58.1 (44.6 to 75.6) | 66.6 (53.4 to 83.1) |
| Visit 9/Day 212 | 29 (22.2 to 38) | 29.7 (22.7 to 38.8) | 34.4 (27.6 to 42.9) |
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
| Titers | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Screening | 5.1 (5 to 5.1) | 5 (5 to 5.1) | 5 (5 to 5) |
| Visit 4/Day 29 | 5.2 (4.9 to 5.5) | 5 (5 to 5.1) | 5.2 (4.9 to 5.4) |
| Visit 7/Day 50 | 53 (39.9 to 70.3) | 67.1 (46.3 to 97.1) | 81.9 (60.1 to 111.7) |
| Visit 8/Day 121 | 15.1 (12.2 to 18.8) | 18.5 (14.5 to 23.5) | 25.6 (19.7 to 33.1) |
| Visit 9/Day 212 | 8.2 (7 to 9.7) | 10.7 (8.9 to 13) | 14 (10.8 to 18) |
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
| Titers | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 |
|---|---|---|---|
| Screening | 5 (5 to 5.1) | 5 (5 to 5) | 5.2 (4.9 to 5.4) |
| Visit 4/Day 29 | 6.4 (5.7 to 7.3) | 7.8 (6.7 to 9.1) | 8.9 (7.2 to 11.2) |
| Visit 7/Day 50 | 256.1 (190.3 to 344.6) | 326.2 (238.1 to 446.9) | 394.9 (303.8 to 513.4) |
| Visit 8/Day 121 | 58.4 (44.9 to 76) | 71.6 (53.6 to 95.6) | 95.4 (73.3 to 124.4) |
| Visit 9/Day 212 | 31.5 (23.7 to 41.9) | 34.4 (26.1 to 45.4) | 41.1 (32 to 52.7) |
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
| Titers | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 |
|---|---|---|---|
| Screening | 5.1 (5 to 5.2) | 5.3 (5 to 5.6) | 5.1 (5 to 5.1) |
| Visit 4/Day 29 | 5.8 (5.2 to 6.5) | 6 (5.3 to 6.7) | 5.9 (5.4 to 6.4) |
| Visit 7/Day 50 | 67.3 (51.4 to 88) | 87.1 (59.8 to 126.9) | 113.8 (80.4 to 161.1) |
| Visit 8/Day 121 | 15.7 (12.5 to 19.8) | 20 (15 to 26.6) | 27.1 (20 to 36.7) |
| Visit 9/Day 212 | 8.7 (7.3 to 10.5) | 11.5 (9.2 to 14.4) | 15.2 (11.6 to 19.9) |
Collected over 13 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 3.75 ug Panblok H7 Plus AS03 | 0/62 (0%) | 3/62 (4.8%) | 48/62 (77.4%) |
| 7.5 ug Panblok H7 Plus AS03 | 0/60 (0%) | 1/60 (1.7%) | 47/60 (78.3%) |
| 15 ug Panblok H7 Plus AS03 | 0/62 (0%) | 3/62 (4.8%) | 40/62 (64.5%) |
| 3.75 ug Panblok H7 Plus MF59 | 0/61 (0%) | 1/61 (1.6%) | 47/61 (77%) |
| 7.5 ug Panblok H7 Plus MF59 | 0/60 (0%) | 2/60 (3.3%) | 40/60 (66.7%) |
| 15 ug Panblok H7 Plus MF59 | 0/61 (0%) | 0/61 (0%) | 42/61 (68.9%) |
| Event | 3.75 ug Panblok H7 Plus AS03 | 7.5 ug Panblok H7 Plus AS03 | 15 ug Panblok H7 Plus AS03 | 3.75 ug Panblok H7 Plus MF59 | 7.5 ug Panblok H7 Plus MF59 | 15 ug Panblok H7 Plus MF59 |
|---|---|---|---|---|---|---|
| Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/62 | 0/60 | 0/62 | 0/61 | 1/60 | 0/61 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/62 | 1/60 | 0/62 | 0/61 | 1/60 | 0/61 |
| Cardiac septal defectCongenital, familial and genetic disorders | 0/62 | 0/60 | 0/62 | 1/61 | 0/60 | 0/61 |
| Pulmonary artery stenosis congenitalCongenital, familial and genetic disorders | 0/62 | 0/60 | 0/62 | 1/61 | 0/60 | 0/61 |
| BronchitisInfections and infestations | 0/62 | 0/60 | 0/62 | 1/61 | 0/60 | 0/61 |
| Meningitis asepticInfections and infestations | 0/62 | 0/60 | 0/62 | 1/61 | 0/60 | 0/61 |
| NephrolithiasisRenal and urinary disorders | 0/62 | 0/60 | 0/62 | 1/61 | 0/60 | 0/61 |
| AppendicitisInfections and infestations | 0/62 | 0/60 | 1/62 | 0/61 | 0/60 | 0/61 |
| DiverticulitisInfections and infestations | 0/62 | 0/60 | 1/62 | 0/61 | 0/60 | 0/61 |
| ArthritisMusculoskeletal and connective tissue disorders | 1/62 | 0/60 | 0/62 | 0/61 | 0/60 | 0/61 |
| Event | 3.75 ug Panblok H7 Plus AS03 | 7.5 ug Panblok H7 Plus AS03 | 15 ug Panblok H7 Plus AS03 | 3.75 ug Panblok H7 Plus MF59 | 7.5 ug Panblok H7 Plus MF59 | 15 ug Panblok H7 Plus MF59 |
|---|---|---|---|---|---|---|
| Injection site painGeneral disorders | 42/62 | 42/60 | 36/62 | 32/61 | 29/60 | 29/61 |
| HeadacheNervous system disorders | 21/62 | 17/60 | 16/62 | 16/61 | 16/60 | 15/61 |
| MyalgiaMusculoskeletal and connective tissue disorders | 14/62 | 19/60 | 18/62 | 16/61 | 8/60 | 13/61 |
| FatigueGeneral disorders | 17/62 | 15/60 | 19/62 | 16/61 | 11/60 | 10/61 |
| NauseaGastrointestinal disorders | 7/62 | 7/60 | 10/62 | 12/61 | 4/60 | 9/61 |
| DiarrhoeaGastrointestinal disorders | 2/62 | 5/60 | 9/62 | 9/61 | 10/60 | 8/61 |
| Injection site indurationGeneral disorders | 3/62 | 8/60 | 6/62 | 7/61 | 2/60 | 1/61 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/62 | 6/60 | 6/62 | 8/61 | 1/60 | 2/61 |
| ChillsGeneral disorders | 7/62 | 7/60 | 6/62 | 6/61 | 5/60 | 4/61 |
| Injection site erythemaGeneral disorders | 5/62 | 7/60 | 3/62 | 7/61 | 2/60 | 2/61 |
| Age, Categorical(Participants) | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 2 | 1 | 0 | 0 | 3 |
| Between 18 and 65 years | 62 | 60 | 60 | 60 | 60 | 61 | 363 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 34.8 ± 7.92 | 34.3 ± 9.14 | 35.8 ± 9.29 | 35 ± 9.58 | 37.1 ± 7.66 | 35.8 ± 8.53 | 35.4 ± 8.65 |
| Sex/Gender, Customized(Participants) | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 | Total |
|---|---|---|---|---|---|---|---|
| Female | 32 | 31 | 30 | 37 | 37 | 35 | 202 |
| Male | 30 | 29 | 32 | 24 | 23 | 26 | 164 |
| Ethnicity (NIH/OMB)(Participants) | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 6 | 7 | 1 | 2 | 4 | 22 |
| Not Hispanic or Latino | 60 | 54 | 55 | 60 | 58 | 57 | 344 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 2 | 0 | 2 | 0 | 4 |
| Asian | 1 | 1 | 0 | 0 | 1 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 8 | 17 | 8 | 9 | 13 | 5 | 60 |
| White | 50 | 42 | 52 | 51 | 43 | 53 | 291 |
| More than one race | 3 | 0 | 0 | 1 | 1 | 2 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | 3.75 µg Panblok H7 Plus AS03 | 7.5 µg Panblok H7 Plus AS03 | 15 µg Panblok H7 Plus AS03 | 3.75 µg Panblok H7 Plus MF59 | 7.5 µg Panblok H7 Plus MF59 | 15 µg Panblok H7 Plus MF59 | Total |
|---|---|---|---|---|---|---|---|
| United States | 62 | 60 | 62 | 61 | 60 | 61 | 366 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Dec 2017, 2 months.
Results were first posted in Sep 2019, 1 year 9 months after primary completion. A results delay was requested in Feb 2019.
Of 36 non-industry phase 2 interventional studies under Influenza, Human, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 56. This study's 2 months is below that.
Counting every sponsor, half of 122 studies reached it within 10 months; a quarter within 5 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: MF59 · AS03
Biomedical Advanced Research and Development Authority