Influenza, HumanPhase 2NCT03283319
Panblok H7 Vaccine Adjuvanted With AS03 or MF59
A Phase 2 study testing 3.75 ug Panblok H7, 7.5 ug Panblok H7 and 15 ug Panblok H7 in people with Influenza, Human, run by Biomedical Advanced Research and Development Authority at 4 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- 3.75 ug Panblok H7, 7.5 ug Panblok H7 and 15 ug Panblok H7
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Sep 2017to 9 Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or nonpregnant female 18 to 49 years of age, inclusive, at the time of the first study vaccination.
- Provide written informed consent prior to the initiation of any study-related procedures.
- Are able to understand and comply with planned study procedures.
- Have a stable health status based on site investigator's clinical judgment, as established by physical examination, vital signs, and medical history.
- Have access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
- 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.
Who cannot join
- Have had a prior severe reaction to any influenza vaccine or have a known allergy to squalene-based adjuvants.
- 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.
- 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).
- 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.
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- 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.
- 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.
- History of schizophrenia, bipolar disease, psychosis, or severe personality disorder.
- History of hospitalization for psychiatric illness, attempted suicide, or having been deemed a danger to self or others within the past 10 years.
- 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.
- 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).
- 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.
- 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.
- 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.
- Are participating or plan to participate in another interventional clinical trial (either active or follow up phase) during the study period.
- 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.
- Have known human immunodeficiency virus, hepatitis B, or hepatitis C infection (based on medical history).
- Have a history of alcohol or drug abuse in the last 5 years.
- Have a body mass index >35 kg/m2.
- Have a first degree relative with narcolepsy.
- 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.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Rochester Clinical Research, Inc
Rochester, New York, 14609
Heartland Research Associates, LLC
Wichita, Kansas, 67207
About this study
Official title: Randomized, Double-Blinded, Phase 2 Study to Assess Safety and Immunogenicity of Panblok H7 Vaccine at Three Antigen Dose Levels Adjuvanted With AS03® or MF59®
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.
- Conditions
- Influenza, Human
- Being tested
- 3.75 ug Panblok H7, 7.5 ug Panblok H7, 15 ug Panblok H7, MF59, AS03
- Keywords
- Influenza, human, Influenza in Birds, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases, MF59, AS03, Adjuvants, Immunologic
- Medical subject headings
- Influenza, Human, Influenza in Birds, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3.75 ug Panblok H7Biological
0.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL.
7.5 ug Panblok H7Biological
Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL.
15 ug Panblok H7Biological
Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL.
MF59Biological
0.5 mL MF59 (39 mg squalene/mL ) adjuvant.
AS03Biological
0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| 3.75 ug Panblok H7 plus AS03 | Experimental | Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 plus AS03 Receives: Biological: 3.75 ug Panblok H7; Biological: AS03 |
| 7.5 ug Panblok H7 plus AS03 | Experimental | Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with AS03 Receives: Biological: 7.5 ug Panblok H7; Biological: AS03 |
| 15 ug Panblok H7 plus AS03 | Experimental | Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with AS03 Receives: Biological: 15 ug Panblok H7; Biological: AS03 |
| 3.75 ug Panblok H7 plus MF59 | Experimental | Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 adjuvanted with MF59 Receives: Biological: 3.75 ug Panblok H7; Biological: MF59 |
| 7.5 ug Panblok H7 plus MF59 | Experimental | Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with MF59 Receives: Biological: 7.5 ug Panblok H7; Biological: MF59 |
| 15 ug Panblok H7 plus MF59 | Experimental | Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with MF59 Receives: Biological: 15 ug Panblok H7; Biological: MF59 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 50
Secondary outcomes (36)
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant AS03
Count of participants who experienced at least one serious adverse event
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening and Days 29, 50, 121 and 212
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start20 Sep 2017
- Primary completion15 Dec 2017
- Study completion9 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of the six treatment groups at Day 1 and will receive the assigned dose of antigen and adjuvant on Day 1 and Day 29.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedical Advanced Research and Development Authority
- Sponsor type
- US federal agency
- Collaborators
- Rho, Inc.
- Responsible party
- Sponsor
- Investigators
- Mark Adams, MD, Principal investigator, Central Kentucky ResearchMatthew Davis, MD, Principal investigator, Rochester Clinical ResearchCarlos Fierro, MD, Principal investigator, Johnson County Clin-TrialsTerry Poling, MD, Principal investigator, Heartland Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283319
- Sponsor's protocol ID
- BP-I-17-002
- Other IDs
- HHSO100201400004I, TO# HHSO10033001T
- Status last verified
- Apr 2020
- First submitted
- 12 Sep 2017
- Last updated
- 6 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Phase 2 Study to Assess Safety and Immunogenicity of Panblok H7 Vaccine at Three Antigen Dose Levels Adjuvanted With AS03® or MF59®
- ClinicalTrials.gov ID
- NCT03283319
- Acronym / sponsor ID
- BP-I-17-002
- Conditions
- Influenza, Human
- Keywords
- Influenza, human, Influenza in Birds, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Biomedical Advanced Research and Development AuthorityUS federal agency
- Collaborators
- Rho, Inc.
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Posted 25 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Participants will be randomized to one of the six treatment groups at Day 1 and will receive the assigned dose of antigen and adjuvant on Day 1 and Day 29.
| Arm | Type | Receives |
|---|---|---|
| 3.75 ug Panblok H7 plus AS03 | Experimental | Biological: 3.75 ug Panblok H7, Biological: AS03Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 plus AS03 |
| 7.5 ug Panblok H7 plus AS03 | Experimental | Biological: 7.5 ug Panblok H7, Biological: AS03Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with AS03 |
| 15 ug Panblok H7 plus AS03 | Experimental | Biological: 15 ug Panblok H7, Biological: AS03Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with AS03 |
| 3.75 ug Panblok H7 plus MF59 | Experimental | Biological: 3.75 ug Panblok H7, Biological: MF59Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 adjuvanted with MF59 |
| 7.5 ug Panblok H7 plus MF59 | Experimental | Biological: 7.5 ug Panblok H7, Biological: MF59Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with MF59 |
| 15 ug Panblok H7 plus MF59 | Experimental | Biological: 15 ug Panblok H7, Biological: MF59Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with MF59 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or nonpregnant female 18 to 49 years of age, inclusive, at the time of the first study vaccination.
- Provide written informed consent prior to the initiation of any study-related procedures.
- Are able to understand and comply with planned study procedures.
- Have a stable health status based on site investigator's clinical judgment, as established by physical examination, vital signs, and medical history.
- Have access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
Key exclusion criteria (23 listed)
- Have had a prior severe reaction to any influenza vaccine or have a known allergy to squalene-based adjuvants.
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3.75 ug Panblok H70.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL. | Biological | 3.75 ug Panblok H7 plus AS03, 3.75 ug Panblok H7 plus MF59 |
| 7.5 ug Panblok H7Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL. | Biological | 7.5 ug Panblok H7 plus AS03, 7.5 ug Panblok H7 plus MF59 |
| 15 ug Panblok H7Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL. | Biological | 15 ug Panblok H7 plus AS03, 15 ug Panblok H7 plus MF59 |
| MF590.5 mL MF59 (39 mg squalene/mL ) adjuvant. | Biological | 15 ug Panblok H7 plus MF59, 3.75 ug Panblok H7 plus MF59, 7.5 ug Panblok H7 plus MF59 |
| AS030.5 mL AS03 (42.4 mg squalene/mL ) adjuvant. | Biological | 15 ug Panblok H7 plus AS03, 3.75 ug Panblok H7 plus AS03, 7.5 ug Panblok H7 plus AS03 |
Primary outcome
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant AS03
Time frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
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
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant AS03
Time frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
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.
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant MF59
Time frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
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
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant MF59
Time frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
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.
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Time frame: Day 50
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.
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Time frame: Day 50
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.
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Time frame: Day 50
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.
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Time frame: Day 50
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.
36 secondary outcomes
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant AS03
Time frame: Day 1 through Day 394
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant MF59
Time frame: Day 1 through Day 394
Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant AS03
Time frame: Day 1 through Day 394
Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant MF59
Time frame: Day 1 through Day 394
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant AS03
Time frame: Day 1 through Day 394
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant MF59
Time frame: Day 1 through Day 394
Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant AS03
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
Time frame: Day 1 through Day 50
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Time frame: Day 50
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Time frame: Day 50
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Time frame: Day 50
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
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
Time frame: Day 50
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Time frame: Days 29, 50, 121, and 212
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
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
Time frame: Day 50
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
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
Time frame: Day 50
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
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
Time frame: Day 50
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
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
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
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
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
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
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
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
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
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
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
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
Time frame: Day 50
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Time frame: Screening and Days 29, 50, 121 and 212
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
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
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
Time frame: Screening and Days 29, 50, 121 and 212
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3.75 ug Panblok H7, 7.5 ug Panblok H7 and 15 ug Panblok H7 in people with Influenza, Human, run by Biomedical Advanced Research and Development Authority at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant AS03 (time frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.