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CompletedNCT03283319Updated May 6, 2020Results posted

Panblok H7 Vaccine Adjuvanted With AS03 or MF59

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

Phase
Phase 2
Study type
Interventional
Enrollment
366
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Influenza, Human

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Keywords

  • Influenza
  • human
  • Influenza in Birds
  • Orthomyxoviridae Infections
  • RNA Virus Infections
  • Virus Diseases
  • Respiratory Tract Infections
  • Respiratory Tract Diseases
  • MF59
  • AS03
  • Adjuvants
  • Immunologic
03

Who can participate

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

Inclusion criteria

  1. Male or nonpregnant female 18 to 49 years of age, inclusive, at the time of the first study vaccination.
  2. Provide written informed consent prior to the initiation of any study-related procedures.
  3. Are able to understand and comply with planned study procedures.
  4. Have a stable health status based on site investigator's clinical judgment, as established by physical examination, vital signs, and medical history.
  5. Have access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
  6. Agree to stay in contact with the study site for the duration of the study, have no current plans to move from the study area, and agree to provide updated contact information as necessary.

Exclusion criteria

Exclusion Criteria:

  1. Have had a prior severe reaction to any influenza vaccine or have a known allergy to squalene-based adjuvants.

  2. Women who are pregnant or breast feeding. Women of childbearing potential 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.

  3. Women of childbearing potential who refuse to use an acceptable method of birth control 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).

  4. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months, or plans to receive immunosuppressive therapy/cytotoxic treatment during study participation.
  5. Have an active neoplastic disease or a history of any hematologic malignancy. However, participants with superficial skin cancer who do not require intervention other than local excision are not excluded.
  6. Have long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or prednisone equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 µg/day of beclomethasone dipropionate or equivalent) within 1 month prior to screening in this study. However, participants on low-dose inhaled steroids (≤800 µg/day of beclomethasone dipropionate or equivalent) or topical steroids are not excluded.
  7. History of schizophrenia, bipolar disease, psychosis, or severe personality disorder.
  8. History of hospitalization for psychiatric illness, attempted suicide, or having been deemed a danger to self or others within the past 10 years.
  9. Have received immunoglobulin or other blood product (with the exception of Rho[D] immune globulin) within the 3 months prior to screening in this study.
  10. Have received any live vaccines within 4 weeks or inactivated or recombinant protein vaccines within 2 weeks prior to screening in this study or plan to receive such vaccines (including seasonal influenza vaccines) from screening through 21 days following the second dose of the study vaccine (Screening Visit through Day 50).
  11. Have an acute or chronic medical condition that, in the opinion of the site investigator, would render vaccination unsafe or would interfere with the evaluation of responses. This includes all PIMMCs such as Guillain Barré syndrome, narcolepsy, and current or history of autoimmune or chronic inflammatory disease.
  12. Have an acute illness, including body temperature greater than 100.4°F, at screening, immediately prior to each vaccination or, per participant report, within 3 days prior to each vaccination in this study.
  13. Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to screening in this study or expect to receive an experimental agent during the study period.
  14. Are participating or plan to participate in another interventional clinical trial (either active or follow up phase) during the study period.
  15. Participated in an A(H7) influenza vaccine study in the past or have a history of A(H7) influenza infection prior to vaccination in this study.
  16. Have known human immunodeficiency virus, hepatitis B, or hepatitis C infection (based on medical history).
  17. Have a history of alcohol or drug abuse in the last 5 years.
  18. Have a body mass index >35 kg/m2.
  19. Have a first degree relative with narcolepsy.
  20. Have any laboratory test result or clinical findings (including vital signs) that singly or in combination are likely to unfavorably alter the risk-benefit of participation or to confound study safety or immunogenicity results. participants cannot be rescreened based on abnormal laboratory test results.
  21. Alanine aminotransferase (AST) >2 times the upper limit of normal (ULN), or bilirubin >1.5 times the ULN unless isolated Gilbert's syndrome. participants cannot be rescreened based on abnormal laboratory test results.
04

Study design

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

Study arms

  • Experimental
    3.75 ug Panblok H7 plus AS03

    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

  • Experimental
    7.5 ug Panblok H7 plus 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

  • Experimental
    15 ug Panblok H7 plus 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

  • Experimental
    3.75 ug Panblok H7 plus MF59

    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

  • Experimental
    7.5 ug Panblok H7 plus 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

  • Experimental
    15 ug Panblok H7 plus 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

Interventions

  • Biological3.75 ug Panblok H7

    0.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL.

  • Biological7.5 ug Panblok H7

    Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL.

  • Biological15 ug Panblok H7

    Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL.

  • BiologicalMF59

    0.5 mL MF59 (39 mg squalene/mL ) adjuvant.

  • BiologicalAS03

    0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.

05

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

06

Results

Posted Sep 25, 2019

Participant flow

Participant flow — Overall Study
Milestone3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS033.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Started626062616061
Completed555455545657
Not completed767744
Withdrew: Lost to follow-up545543
Withdrew: Withdrawal by subject222101
Withdrew: Barda regulatory agency or irb decision000100

Outcome measures

PrimarySolicited 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)
Reported as:
Count of participants · Participants
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant AS03424436
PrimarySolicited 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)
Reported as:
Count of participants · Participants
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant AS03252827
PrimarySolicited 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)
Reported as:
Count of participants · Participants
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant MF59373029
PrimarySolicited 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)
Reported as:
Count of participants · Participants
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant MF59272428
PrimarySeroprotection 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
Reported as:
Count of participants · Participants
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03535356
PrimarySeroprotection 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
Reported as:
Count of participants · Participants
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59474748
PrimarySeroprotection 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
Reported as:
Count of participants · Participants
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03485255
PrimarySeroprotection 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
Reported as:
Count of participants · Participants
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59373547
SecondaryTreatment-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
Reported as:
Count of participants · Participants
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant AS03313
SecondaryTreatment-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
Reported as:
Count of participants · Participants
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant MF59120
SecondaryTreatment-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
Reported as:
Count of participants · Participants
Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant AS0311813
SecondaryTreatment-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
Reported as:
Count of participants · Participants
Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant MF5991610
SecondaryTreatment-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
Reported as:
Count of participants · Participants
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant AS03000
SecondaryTreatment-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
Reported as:
Count of participants · Participants
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant MF59000
SecondaryTreatment-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
Reported as:
Count of participants · Participants
Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant AS03242522
SecondaryTreatment-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
Reported as:
Count of participants · Participants
Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant MF59242421
SecondarySeroprotection 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
Reported as:
Count of participants · Participants
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03555558
SecondarySeroprotection 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
Reported as:
Count of participants · Participants
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59383647
SecondarySeroprotection 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
Reported as:
Count of participants · Participants
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03505457
SecondarySerum 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
Reported as:
Geometric mean · Titers
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Titers3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Screening5.1 (5.0 to 5.2)5.3 (5.0 to 5.7)5.5 (5.1 to 5.9)
Visit 4/Day 298.7 (7 to 10.8)12.3 (9.4 to 16)12.4 (9.2 to 16.8)
Visit 7/Day 50297.1 (216.5 to 407.7)438.3 (329.4 to 583)505.9 (399.7 to 640.2)
Visit 8/Day 12158.8 (43.9 to 78.8)73 (55.5 to 96)90 (70.2 to 115.3)
Visit 9/Day 21221.2 (15.6 to 28.8)21.6 (16.2 to 28.7)26 (18.9 to 35.7)
SecondarySeroprotection 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
Reported as:
Count of participants · Participants
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59484848
SecondarySeroconversion 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
Reported as:
Count of participants · Participants
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Visit 4/Day 29001
Visit 7/Day 50515054
Visit 8/Day 121344044
Visit 9/Day 212222528
SecondarySerum 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
Reported as:
Geometric mean · Titers
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Titers3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Screening5.1 (5 to 5.2)5.5 (5 to 6.1)5.1 (5 to 5.2)
Visit 4/Day 296.1 (5.1 to 7.3)6.6 (5.7 to 7.7)6.4 (5.6 to 7.3)
Visit 7/Day 5076.3 (55.9 to 104)106.5 (74.1 to 153)130.6 (93.1 to 183.2)
Visit 8/Day 12118.1 (13.6 to 24.1)20.7 (14.9 to 28.8)33.2 (25.1 to 43.9)
Visit 9/Day 2126.8 (6 to 7.7)8.9 (7.1 to 11.1)11.4 (8.7 to 15)
SecondarySerum 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
Reported as:
Geometric mean · Titers
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Titers3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF5975.4 (55.6 to 102.4)103 (72.1 to 147.2)124.3 (87.9 to 175.8)
SecondarySerum 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
Reported as:
Geometric mean · Titers
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Titers3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Screening5 (5 to 5)5.2 (4.9 to 5.6)5.2 (5 to 5.4)
Visit 4/Day 295.9 (5.2 to 6.7)8.3 (6.7 to 10.3)8.4 (6.6 to 10.7)
Visit 7/Day 50170.2 (119.9 to 241.7)302 (218.9 to 416.7)316.7 (246.2 to 407.4)
Visit 8/Day 12145.2 (33.4 to 61.1)57.7 (42.5 to 78.4)69.7 (53.1 to 91.6)
Visit 9/Day 21225 (18.3 to 34.2)28.1 (20.1 to 39.2)32.9 (24.4 to 44.4)
SecondarySerum 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
Reported as:
Geometric mean · Titers
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Titers3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03163.8 (115.7 to 231.9)274.9 (195.3 to 386.9)313.1 (243.1 to 403.1)
SecondarySerum 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
Reported as:
Geometric mean · Titers
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Titers3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Screening5.1 (5 to 5.2)5.1 (5 to 5.2)5.3 (4.8 to 5.8)
Visit 4/Day 295.7 (5.1 to 6.3)5.6 (5.1 to 6.1)5.6 (5.2 to 6.1)
Visit 7/Day 5047.6 (33.7 to 67.1)60.5 (40.5 to 90.4)74.5 (53.3 to 104)
Visit 8/Day 12113 (10.2 to 16.6)15.1 (11.2 to 20.4)20.9 (15.6 to 27.8)
Visit 9/Day 2127.8 (6.7 to 9.1)11.3 (8.6 to 14.8)13.6 (10.1 to 18.2)
SecondarySerum 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
Reported as:
Geometric mean · Titers
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Titers3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF5947.4 (33.8 to 66.5)58.6 (39.4 to 87.2)71.1 (50.6 to 100)
SecondarySeroprotection 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
Reported as:
Count of participants · Participants
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Screening000
Visit 4/Day 2971013
Visit 8/Day 121404547
Visit 9/Day 212211923
SecondarySeroprotection 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
Reported as:
Count of participants · Participants
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Screening000
Visit 4/Day 29130
Visit 8/Day 121192434
Visit 9/Day 212147
SecondarySeroprotection 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
Reported as:
Count of participants · Participants
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Screening000
Visit 4/Day 29254
Visit 8/Day 121374045
Visit 9/Day 212222226
SecondarySeroprotection 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
Reported as:
Count of participants · Participants
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Screening001
Visit 4/Day 29100
Visit 8/Day 121101522
Visit 9/Day 2121811
SecondarySeroconversion 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
Reported as:
Count of participants · Participants
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Visit 4/Day 2971012
Visit 7/Day 50535356
Visit 8/Day 121404547
Visit 9/Day 212211923
SecondarySeroconversion 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
Reported as:
Count of participants · Participants
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Visit 4/Day 29120
Visit 7/Day 50474748
Visit 8/Day 121192334
Visit 9/Day 212147
SecondarySeroconversion 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
Reported as:
Count of participants · Participants
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Visit 4/Day 29254
Visit 7/Day 50485255
Visit 8/Day 121373945
Visit 9/Day 212222226
SecondarySeroconversion 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
Reported as:
Count of participants · Participants
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Visit 4/Day 29100
Visit 7/Day 50373547
Visit 8/Day 121101521
Visit 9/Day 2121811
SecondarySeroconversion 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
Reported as:
Count of participants · Participants
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Visit 4/Day 29000
Visit 7/Day 50403944
Visit 8/Day 121111421
Visit 9/Day 2122411
SecondarySeroconversion 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
Reported as:
Count of participants · Participants
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Participants3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Visit 4/Day 29027
Visit 7/Day 50535356
Visit 8/Day 121384347
Visit 9/Day 212252834
SecondarySeroconversion 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
Reported as:
Count of participants · Participants
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Participants3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Visit 4/Day 29110
Visit 7/Day 50464447
Visit 8/Day 121112127
Visit 9/Day 2123615
SecondarySerum 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
Reported as:
Geometric mean · Titers
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Titers3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03276.3 (200.1 to 381.5)400.7 (291.9 to 550.1)489.1 (383 to 624.5)
SecondarySerum 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
Reported as:
Geometric mean · Titers
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Titers3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Screening5.0 (5 to 5)5 (5 to 5)5 (5 to 5)
Visit 4/Day 295.3 (5 to 5.5)6.2 (5.6 to 6.9)6.3 (5.5 to 7.2)
Visit 7/Day 50201.2 (147.4 to 274.6)274.3 (197.4 to 381.2)286.3 (218.1 to 375.7)
Visit 8/Day 12151.4 (40.8 to 64.7)58.1 (44.6 to 75.6)66.6 (53.4 to 83.1)
Visit 9/Day 21229 (22.2 to 38)29.7 (22.7 to 38.8)34.4 (27.6 to 42.9)
SecondarySerum 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
Reported as:
Geometric mean · Titers
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Titers3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Screening5.1 (5 to 5.1)5 (5 to 5.1)5 (5 to 5)
Visit 4/Day 295.2 (4.9 to 5.5)5 (5 to 5.1)5.2 (4.9 to 5.4)
Visit 7/Day 5053 (39.9 to 70.3)67.1 (46.3 to 97.1)81.9 (60.1 to 111.7)
Visit 8/Day 12115.1 (12.2 to 18.8)18.5 (14.5 to 23.5)25.6 (19.7 to 33.1)
Visit 9/Day 2128.2 (7 to 9.7)10.7 (8.9 to 13)14 (10.8 to 18)
SecondarySerum 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
Reported as:
Geometric mean · Titers
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Titers3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS03
Screening5 (5 to 5.1)5 (5 to 5)5.2 (4.9 to 5.4)
Visit 4/Day 296.4 (5.7 to 7.3)7.8 (6.7 to 9.1)8.9 (7.2 to 11.2)
Visit 7/Day 50256.1 (190.3 to 344.6)326.2 (238.1 to 446.9)394.9 (303.8 to 513.4)
Visit 8/Day 12158.4 (44.9 to 76)71.6 (53.6 to 95.6)95.4 (73.3 to 124.4)
Visit 9/Day 21231.5 (23.7 to 41.9)34.4 (26.1 to 45.4)41.1 (32 to 52.7)
SecondarySerum 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
Reported as:
Geometric mean · Titers
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Titers3.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59
Screening5.1 (5 to 5.2)5.3 (5 to 5.6)5.1 (5 to 5.1)
Visit 4/Day 295.8 (5.2 to 6.5)6 (5.3 to 6.7)5.9 (5.4 to 6.4)
Visit 7/Day 5067.3 (51.4 to 88)87.1 (59.8 to 126.9)113.8 (80.4 to 161.1)
Visit 8/Day 12115.7 (12.5 to 19.8)20 (15 to 26.6)27.1 (20 to 36.7)
Visit 9/Day 2128.7 (7.3 to 10.5)11.5 (9.2 to 14.4)15.2 (11.6 to 19.9)

Adverse events

Collected over 13 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
3.75 ug Panblok H7 Plus AS030/62 (0%)3/62 (4.8%)48/62 (77.4%)
7.5 ug Panblok H7 Plus AS030/60 (0%)1/60 (1.7%)47/60 (78.3%)
15 ug Panblok H7 Plus AS030/62 (0%)3/62 (4.8%)40/62 (64.5%)
3.75 ug Panblok H7 Plus MF590/61 (0%)1/61 (1.6%)47/61 (77%)
7.5 ug Panblok H7 Plus MF590/60 (0%)2/60 (3.3%)40/60 (66.7%)
15 ug Panblok H7 Plus MF590/61 (0%)0/61 (0%)42/61 (68.9%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
Event3.75 ug Panblok H7 Plus AS037.5 ug Panblok H7 Plus AS0315 ug Panblok H7 Plus AS033.75 ug Panblok H7 Plus MF597.5 ug Panblok H7 Plus MF5915 ug Panblok H7 Plus MF59
Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/620/600/620/611/600/61
Abortion spontaneousPregnancy, puerperium and perinatal conditions0/621/600/620/611/600/61
Cardiac septal defectCongenital, familial and genetic disorders0/620/600/621/610/600/61
Pulmonary artery stenosis congenitalCongenital, familial and genetic disorders0/620/600/621/610/600/61
BronchitisInfections and infestations0/620/600/621/610/600/61
Meningitis asepticInfections and infestations0/620/600/621/610/600/61
NephrolithiasisRenal and urinary disorders0/620/600/621/610/600/61
AppendicitisInfections and infestations0/620/601/620/610/600/61
DiverticulitisInfections and infestations0/620/601/620/610/600/61
ArthritisMusculoskeletal and connective tissue disorders1/620/600/620/610/600/61
Most frequent other events
Showing 10 of 14
Most frequent other events
Event3.75 ug Panblok H7 Plus AS037.5 ug Panblok H7 Plus AS0315 ug Panblok H7 Plus AS033.75 ug Panblok H7 Plus MF597.5 ug Panblok H7 Plus MF5915 ug Panblok H7 Plus MF59
Injection site painGeneral disorders42/6242/6036/6232/6129/6029/61
HeadacheNervous system disorders21/6217/6016/6216/6116/6015/61
MyalgiaMusculoskeletal and connective tissue disorders14/6219/6018/6216/618/6013/61
FatigueGeneral disorders17/6215/6019/6216/6111/6010/61
NauseaGastrointestinal disorders7/627/6010/6212/614/609/61
DiarrhoeaGastrointestinal disorders2/625/609/629/6110/608/61
Injection site indurationGeneral disorders3/628/606/627/612/601/61
ArthralgiaMusculoskeletal and connective tissue disorders5/626/606/628/611/602/61
ChillsGeneral disorders7/627/606/626/615/604/61
Injection site erythemaGeneral disorders5/627/603/627/612/602/61

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS033.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59Total
<=18 years0021003
Between 18 and 65 years626060606061363
>=65 years0000000
Age, Continuous
Age, Continuous(years)3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS033.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59Total
Mean34.8 ± 7.9234.3 ± 9.1435.8 ± 9.2935 ± 9.5837.1 ± 7.6635.8 ± 8.5335.4 ± 8.65
Sex/Gender, Customized
Sex/Gender, Customized(Participants)3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS033.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59Total
Female323130373735202
Male302932242326164
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS033.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59Total
Hispanic or Latino26712422
Not Hispanic or Latino605455605857344
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS033.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59Total
American Indian or Alaska Native0020204
Asian1100114
Native Hawaiian or Other Pacific Islander0000000
Black or African American8178913560
White504252514353291
More than one race3001127
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(participants)3.75 µg Panblok H7 Plus AS037.5 µg Panblok H7 Plus AS0315 µg Panblok H7 Plus AS033.75 µg Panblok H7 Plus MF597.5 µg Panblok H7 Plus MF5915 µg Panblok H7 Plus MF59Total
United States626062616061366
07

Study locations

4 sites
  • Johnson County Clin-Trials
    Lenexa, Kansas 66219, United States
  • Heartland Research Associates, LLC
    Wichita, Kansas 67207, United States
  • Central Kentucky Research Associates, Inc.
    Lexington, Kentucky 40509, United States
  • Rochester Clinical Research, Inc
    Rochester, New York 14609, United States
08

References and documents

Study documents

  • Study protocol · Jul 3, 2017
  • Statistical analysis plan · Oct 17, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03283319
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborators
Rho, Inc.
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Sep 20, 2017
Primary completion
Dec 15, 2017
Completion
Nov 9, 2018
Results posted
Sep 25, 2019
Last update
May 6, 2020

Study contacts

Mark Adams, MD
principal investigator · Central Kentucky Research
Matthew Davis, MD
principal investigator · Rochester Clinical Research
Carlos Fierro, MD
principal investigator · Johnson County Clin-Trials
Terry Poling, MD
principal investigator · Heartland Research Associates

Oversight

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

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