AzTrials
AzTrials

Avian InfluenzaPhase 1NCT02251288

A Phase I Study Priming With an Inactivated A/H7N9 Influenza Virus Vaccine With or Without MF59 Adjuvant Followed by Live Attenuated A/H7N9 Influenza Virus Vaccine

A Phase 1 study testing Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca, Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 and MF59 adjuvant in people with Avian Influenza and Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A phase I prospective, randomized study in healthy adult subjects at a single center. Adult subjects age 18 to 47 years and meeting all enrollment criteria will choose to participate as subjects who receive inactivated vaccine followed by a live vaccine boost at 4 weeks (Group 1), 12 weeks (Group 2), or 24 weeks… Read more about this study

Who is it for?
Ages 18 to 47 yearsHealthy volunteers can take part
Conditions the study is for
Avian Influenza, Immunisation
What is being tested?
Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca, Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 and MF59 adjuvant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
18 May 2015to 17 Aug 2018
Phase
Phase 1
Are there results?
None posted in the registry

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 47 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Provide written informed consent prior to initiation of any study procedures, including future use of specimens.
  • Are able to understand and comply with planned study procedures and be available for all study visits.
  • Are males or non-pregnant, non-breastfeeding females, 18 to 47 years old, inclusive.
  • Are in good health, as determined by medical history, and targeted physical examination to ensure any existing medical diagnoses or conditions (except those exclusionary) are stable* **.
  • Stable chronic medical condition - no change in prescription medication, dose, or frequency of medication in the last 3 months (defined as 90 days) and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months (defined as 180 days). Any change that is due to change of health care provider, insurance company etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a violation of this inclusion criterion.
  • Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity. Note: Topical, nasal, and inhaled medications (with the exception of steroids as outlined in the Subject Exclusion Criteria), vitamins, and contraceptives are permitted.
Show all 14Show fewer
  • Oral temperature is less than 100.4 degrees Fahrenheit.
  • Pulse is 55 to 100 bpm, inclusive.
  • Systolic blood pressure is 90 to 140 mmHg, inclusive.
  • Diastolic blood pressure is 55 to 90 mmHg, inclusive.
  • Women of childbearing potential* in sexual relationships with men must use an acceptable method of contraception** from 30 days prior to pIIV administration until 90 days after last study vaccination.
  • Not sterilized via tubal ligation, bilateral oophorectomy or hysterectomy and still menstruating or < 1 year of the last menses if menopausal).
  • Includes, but is not limited to, abstinence from intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, and licensed hormonal methods, with use of a highly effective method of contraception for a minimum of 30 days prior to study product exposure and agree to practice highly effective contraception for the duration of study product exposure, including 3 months (defined as 90 days) after the last study vaccination. A highly effective method of contraception is defined as one which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
  • Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.

Who cannot join

  • Have an acute illness within 72 hours prior to study vaccination.
  • Any medical disease or condition that, in the opinion of the investigator, is a contraindication to study participation*.
  • Includes medical disease or condition that would place the subject at an unacceptable risk of injury, render them unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or their successful completion of the study.
  • Have history of any significant acute or chronic medical conditions* or need for chronic medications that, in the opinion of the investigator, will interfere with immunogenicity or affect safety.
  • Chronic medical condition - a medical condition persisting 3 months (defined as 90 days) or longer
  • Have immunosuppression or are taking systemic immunosuppressants as a result of an underlying illness or treatment.
Show all 40Show fewer
  • Diagnosis of asthma or reactive airway disease within the past 2 years.
  • History of surgical splenectomy.
  • Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 36 months prior to vaccination.
  • Have known active neoplastic disease or a history of any hematologic malignancy.
  • Have known hepatitis B or hepatitis C infection.
  • Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.
  • Known allergy or intolerance to oseltamivir.
  • Have a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.
  • Have a history of Guillain-Barré Syndrome.
  • Have a history of neuralgia, paresthesia, neuritis, convulsions, or encephalomyelitis within 90 days prior to study vaccination.
  • Have a history of autoimmune disease*.
  • Including, but not limited to, neuroinflammatory diseases, vasculitis, clotting disorders, dermatitis, arthritis, thyroiditis, or muscle, liver, or kidney disease.
  • Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
  • Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
  • Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.
  • Have taken oral or parenteral corticosteroids of any dose within 30 days prior to study vaccination.
  • Chronic use (defined as daily use for > 7days within the 30 days prior to study vaccination) of any inhaled medication, including inhaled corticosteroids.
  • Received any licensed live vaccine within 30 days prior to pIIV vaccination. This is inclusive of licensed seasonal influenza vaccines.
  • Received any licensed inactivated vaccine within 14 days prior to pIIV vaccination. This is inclusive of licensed seasonal influenza vaccines.
  • Planned receipt of any vaccine from the first study vaccination through the follow-up visit at approximately 56 days after the second study vaccination. This is inclusive of licensed seasonal influenza vaccines
  • Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination.
  • Received an experimental agent* within 30 days prior to pIIV administration or planned receipt of an experimental agent to within 90 days after pLAIV administration.
  • Includes vaccine, drug, biologic, device, blood product, or medication.
  • Plans to enroll in another clinical trial* that could interfere with safety assessment of the investigational product at any time during the study period.
  • Includes trials that have a study intervention such as a drug, biologic, or device
  • Prior participation in a clinical trial of influenza A/H7 vaccine* or have a history of A/H7 actual or potential exposure or infection prior to the first study vaccination.
  • Documented receipt of placebo in such a trial is not exclusionary
  • Plan to travel outside the U.S. (continental U.S., Hawaii and Alaska) in the time between the first study vaccination and 56 days after the second study vaccination.
  • Positive screening pregnancy test or other evidence of pregnancy.
  • Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after their last study vaccination.
  • Seropositive to the H7N9 influenza A virus (serum HAI titer > 1:8) during the screening period prior to the first study vaccination.
  • Positive urine drug screen for opiates and cocaine at the time of check-in for the period of confinement.
  • Positive ELISA and confirmatory Western blot tests for human immunodeficiency virus-1 (HIV-1) during the screening period prior to vaccination.
  • Current smoker unwilling to stop smoking for the period of confinement. A nicotine patch during the period of confinement may be offered.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Rochester Medical Center - Vaccine Research Unit

    Rochester, New York, 14642-0001

Other trials in United States

About this study

Official title: A Phase I Randomized Study in Healthy Adults to Assess the Safety, Reactogenicity and Immunogenicity of Priming With an Inactivated A/H7N9 Influenza Virus Vaccine With or Without MF59 Adjuvant Followed by Live Attenuated A/H7N9 Influenza Virus Vaccine

A phase I prospective, randomized study in healthy adult subjects at a single center. Adult subjects age 18 to 47 years and meeting all enrollment criteria will choose to participate as subjects who receive inactivated vaccine followed by a live vaccine boost at 4 weeks (Group 1), 12 weeks (Group 2), or 24 weeks (Group 3), or to be in an observational group (Group 4) which will not be scheduled for a booster dose but may serve as a roll-over group for subjects who withdraw prior to the second vaccination but agree to remain in follow-up. A fifth group will receive two intramuscular doses of adjuvanted H7N9 pIIV separated by four weeks. The primary objectives of this study are to (1) assess the safety of H7N9 pLAIV administered to individuals who have previously received MF59-adjuvanted or unadjuvanted H7N9 pIIV, (2) evaluate the ability of a single dose of unadjuvanted H7N9 pIIV to prime for enhanced immunogenicity (booster response) to subsequent administration of antigenically-matched H7N9 pLAIV vaccine, and to (3) evaluate the ability of a single dose of MF59-adjuvanted H7N9 pIIV to prime for enhanced immunogenicity (booster response) to subsequent administration of antigenically-matched H7N9 pLAIV vaccine.

Read the detailed description

The study will be conducted as a Phase I prospective, randomized study in healthy adult subjects at a single center. Adult subjects age 18 to 47 years and meeting all enrollment criteria will choose to participate as subjects who receive unadjuvanted or adjuvanted H7H9 pIIV vaccine followed by a live vaccine boost at 4 weeks (Group 1, n=24), 12 weeks (Group 2, n=24), or 24 weeks (Group 3, n=24), or to be in an observational group (Group 4, n=16) which will not be scheduled for a booster dose but may serve as a roll-over group for subjects who withdraw prior to the second vaccination but agree to remain in follow-up. Within each group, subjects will be randomized at a 1:1 ratio to receive a single dose of either unadjuvanted H7N9 pIIV at 15 mcg (Subgroup A), or the same vaccine adjuvanted with the oil-in-water emulsion, MF59, (Subgroup B) delivered intramuscularly. Finally, a fifth group (Group 5, n=12) will receive two intramuscular doses of adjuvanted H7N9 pIIV separated by four weeks. The total duration of study participation for all subjects will be approximately 13 months. Recruitment, enrollment and administration of study product will be suspended when one of the following occurs in the clinical or research laboratory at the clinical site: at least two respiratory cultures or PCR assays are determined to be positive for influenza or at least 10% diagnostic tests (rapid tests, respiratory cultures or PCR assays) performed for influenza as positive during two consecutive weeks in the clinical or research laboratory at the clinical site. Recruitment, enrollment and administration of study product may be resumed after 2 weeks without a signal that influenza is still circulating in the community, as defined by the same measures that indicate the start of influenza season (i.e., less than 2 respiratory cultures or PCR assays are determined to positive for influenza or less than 10% of diagnostic tests performed or influenza with positive results). The primary objectives of this study are to (1) assess the safety of H7N9 pLAIV administered to individuals who have previously received MF59-adjuvanted or unadjuvanted H7N9 pIIV, (2) evaluate the ability of a single dose of unadjuvanted H7N9 pIIV to prime for enhanced immunogenicity (booster response) to subsequent administration of antigenically-matched H7N9 pLAIV vaccine, and to (3) evaluate the ability of a single dose of MF59-adjuvanted H7N9 pIIV to prime for enhanced immunogenicity (booster response) to subsequent administration of antigenically-matched H7N9 pLAIV vaccine. The secondary objectives of this study are to (1) assess the safety of priming with MF59-adjuvanted H7N9 pIIV or unadjuvanted H7N9 pIIV, (2) assess the immune response in subjects vaccinated with a single dose of MF59-adjuvanted H7N9 pIIV or a single dose of unadjuvanted H7N9 pIIV, and to (3) compare the booster effect seen after intervals of 4 weeks, 12 weeks, or 24 weeks within each priming group.

Being tested
Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca, Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013, MF59 adjuvant
Keywords
H7N9 pandemic, inactivated influenza vaccine (pIIV), live attenuated influenza vaccine (pLAIV), MF59 adjuvant
Medical subject headings
Influenza in Birds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA caBiological

    MedImmune supplies pLAIV vaccines as a colorless to pale yellow and clear to slightly cloudy suspension in single, unit-dose, Becton-Dickinson Accuspray™ Nasal Spray Systems sprayer devices. Each filled sprayer device contains a 0.5 mL dose of 10^7FFU of H7N9 Anhui 2013/AA ca vaccine. Group I receives the IN dose on Day 29, Group 2 on Day 85, and Group 3 on Day 169.

  • Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013Biological

    Sanofi supplies the monovalent influenza A/H7N9 virus vaccine as a sterile, clear, and slightly opalescent suspension in single-dose vials containing 15 mcg HA per 0.5 mL. Group 1 through Group5 will receive the IM vaccine on Day 1

  • MF59 adjuvantDrug

    Novartis supplies the MF59 adjuvant as an oil-in-water milky emulsion in single-use vials containing a fill volume of 0.7 mL. Group 1 through Group 5 will receive MF59 IM on Day 1.

Study groups in NCT02251288
Study groupRoleWhat they receive
Group 1Experimental12 patients receive Intramuscular (IM) A/H7N9 15 mcg on Day 1, 12 patients receive A/H7N9 15 mcg plus MF59 adjuvant IM on Day 1 and all receive single dose of Intranasal (IN) sprayer 10^7 FFU H7 N9 pLAIV on Day 29
Receives: Biological: Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013; Drug: MF59 adjuvant
Group 2Experimental12 patients receive A/H7N9 15 mcg IM on Day 1, 12 patients receive A/H7N9 15 mcg plus MF59 adjuvant IM on Day 1 and all receive single dose of IN sprayer10^7 FFU H7 N9 pLAIV on Day 85
Receives: Biological: Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013; Drug: MF59 adjuvant
Group 3Experimental12 patients receive S A/H7N9 15 mcg IM on Day 1, 12 patients receive A/H7N9 15 mcg plus MF59 adjuvant IM on Day 1 and all receive single dose of IN sprayer 10^7 FFU H7 N9 pLAIV on Day 169
Receives: Biological: Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013; Drug: MF59 adjuvant
Group 4Experimental8 patients receive A/H7N9 15 mcg IM on Day 1, 8 patients receive A/H7N9 15 mcg plus MF59 adjuvant IM on Day 1
Receives: Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013; Drug: MF59 adjuvant
Group 5Experimental12 patients receive A/H7N9 15 mcg plus MF59 adjuvant on Day 1 and Day 29
Receives: Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013; Drug: MF59 adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric mean titers determined by neuraminidase inhibiting antibody by enzyme-linked lectin assay (ELLA)

    Measured: Day 29

  2. Geometric mean titers determined by neuraminidase inhibiting antibody by enzyme-linked lectin assay (ELLA) for Group 2

    Measured: Day 113

  3. Geometric mean titers determined by neuraminidase inhibiting antibody by enzyme-linked lectin assay (ELLA) for Group 3

    Measured: Day 197

  4. Geometric mean titers determined by neuraminidase inhibiting antibody by enzyme-linked lectin assay (ELLA) for Groups 1, 5

    Measured: Day 57

  5. Occurrence of respiratory reactogenicity following pLAIV vaccination for Group 1

    Measured: Day 29 through Day 39

  6. Occurrence of respiratory reactogenicity following pLAIV vaccination for Group 2

    Measured: Day 85 through Day 95

  7. Occurrence of respiratory reactogenicity following pLAIV vaccination for Group 3

    Measured: Day 169 through Day 179

  8. Occurrence of solicited systemic reactogenicity following pLAIV vaccination for Group 1

    Measured: Day 29 through Day 39

  9. Occurrence of solicited systemic reactogenicity following pLAIV vaccination for Group 2

    Measured: Day 85 through Day 95

  10. Occurrence of solicited systemic reactogenicity following pLAIV vaccination for Group 3

    Measured: Day 169 through Day 179

  11. Occurrence of study vaccine-related serious adverse events following pLAIV vaccination for Group 1

    Measured: Day 29 through Day 209

  12. Occurrence of study vaccine-related serious adverse events following pLAIV vaccination for Group 2

    Measured: Day 85 through Day 265

  13. Occurrence of study vaccine-related serious adverse events following pLAIV vaccination for Group 3

    Measured: Day 169 through Day 349

  14. Occurrence of study vaccine-related unsolicited non-serious adverse events following pLAIV vaccination for Group 1

    Measured: Day 29 through Day 57

  15. Occurrence of study vaccine-related unsolicited non-serious adverse events following pLAIV vaccination for Group 2

    Measured: Day 85 through 113

  16. Occurrence of study vaccine-related unsolicited non-serious adverse events following pLAIV vaccination for Group 3

    Measured: Day 169 through 197

  17. Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines for Group 2

    Measured: Day 113

  18. Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines for Group 3

    Measured: Day 197

  19. Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines for Groups 1, 5

    Measured: Day 57

  20. Percentage of subjects achieving seroconversion (a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer = / > 1:40 or a pre-vaccination HAI titer = / > 1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer) for Group 2

    Measured: Day 113

  21. Percentage of subjects achieving seroconversion (a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer = / > 1:40 or a pre-vaccination HAI titer = / > 1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer) for Group 3

    Measured: Day 197

  22. Percentage of subjects achieving seroconversion (a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer = / > 1:40 or a pre-vaccination HAI titer = / > 1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer) for Groups 1,5

    Measured: Day 57

  23. Percentage of subjects shedding vaccine virus as detected by rRT-PCR following pLAIV vaccination for Group 1

    Measured: Day 29 through Day 36

  24. Percentage of subjects shedding vaccine virus as detected by rRT-PCR following pLAIV vaccination for Group 2

    Measured: Day 85 through Day 92

  25. Percentage of subjects shedding vaccine virus as detected by rRT-PCR following pLAIV vaccination for Group 3

    Measured: Day 169 through Day 176

  26. Percentage of subjects with positive B cell responses by plasmablast assays on peripheral blood mononuclear cells

    Measured: Day 29

  27. Percentage of subjects with positive B cell responses by plasmablast assays on peripheral blood mononuclear cells for Group 2

    Measured: Day 113

  28. Percentage of subjects with positive B cell responses by plasmablast assays on peripheral blood mononuclear cells for Group 2

    Measured: Day 141

  29. Percentage of subjects with positive B cell responses by plasmablast assays on peripheral blood mononuclear cells for Group 2

    Measured: Day 265

  30. Percentage of subjects with positive B cell responses by plasmablast assays on peripheral blood mononuclear cells for Group 3

    Measured: Day 197

  31. Percentage of subjects with positive B cell responses by plasmablast assays on peripheral blood mononuclear cells for Group 3

    Measured: Day 225

  32. Percentage of subjects with positive B cell responses by plasmablast assays on peripheral blood mononuclear cells for Group 3

    Measured: Day 349

  33. Percentage of subjects with positive B cell responses by plasmablast assays on peripheral blood mononuclear cells for Groups 1, 5

    Measured: Day 209

  34. Percentage of subjects with positive B cell responses by plasmablast assays on peripheral blood mononuclear cells for Groups 1, 5

    Measured: Day 57

  35. Percentage of subjects with positive B cell responses by plasmablast assays on peripheral blood mononuclear cells for Groups 1, 5

    Measured: Day 85

Secondary outcomes (72)

  1. Geometric mean titers of serum HAI antibody

    Measured: Day 1

  2. Geometric mean titers of serum HAI antibody

    Measured: Day 29

  3. Geometric mean titers of serum HAI antibody for Group 2

    Measured: Day 113

  4. Geometric mean titers of serum HAI antibody for Group 2

    Measured: Day 141

  5. Geometric mean titers of serum HAI antibody for Group 2

    Measured: Day 265

  6. Geometric mean titers of serum HAI antibody for Group 3

    Measured: Day 197

  7. Geometric mean titers of serum HAI antibody for Group 3

    Measured: Day 225

  8. Geometric mean titers of serum HAI antibody for Group 3

    Measured: Day 349

  9. Geometric mean titers of serum HAI antibody for Groups 1, 5

    Measured: Day 209

  10. Geometric mean titers of serum HAI antibody for Groups 1, 5

    Measured: Day 57

  11. Geometric mean titers of serum HAI antibody for Groups 1, 5

    Measured: Day 85

  12. Geometric mean titers of serum NtAb antibody

    Measured: Day 1

  13. Geometric mean titers of serum NtAb antibody

    Measured: Day 29

  14. Geometric mean titers of serum NtAb antibody for Group 2

    Measured: Day 113

  15. Geometric mean titers of serum NtAb antibody for Group 2

    Measured: Day 141

  16. Geometric mean titers of serum NtAb antibody for Group 2

    Measured: Day 265

  17. Geometric mean titers of serum NtAb antibody for Group 3

    Measured: Day 197

  18. Geometric mean titers of serum NtAb antibody for Group 3

    Measured: Day 225

  19. Geometric mean titers of serum NtAb antibody for Group 3

    Measured: Day 349

  20. Geometric mean titers of serum NtAb antibody for Groups 1, 5

    Measured: Day 209

  21. Geometric mean titers of serum NtAb antibody for Groups 1, 5

    Measured: Day 57

  22. Geometric mean titers of serum NtAb antibody for Groups 1, 5

    Measured: Day 85

  23. Occurrence of adverse events of special interest following pIIV vaccination

    Measured: Day 1 through Day 366

  24. Occurrence of adverse events of special interest following pIIV vaccination for Group 5

    Measured: Day 1 through Day 394

  25. Occurrence of local reactogenicity following pIIV vaccination

    Measured: Day 1 through Day 8

  26. Occurrence of local reactogenicity following pIIV vaccination for Group 5

    Measured: Day 29 through Day 36

  27. Occurrence of new-onset chronic medical conditions for Group 2

    Measured: Day 1 through Day 265

  28. Occurrence of new-onset chronic medical conditions for Group 3

    Measured: Day 1 through Day 349

  29. Occurrence of new-onset chronic medical conditions for Group 4

    Measured: Day 1 through Day 181

  30. Occurrence of new-onset chronic medical conditions for Groups 1, 5

    Measured: Day 1 through Day 209

  31. Occurrence of study vaccine-related serious adverse events following pIIV vaccination

    Measured: Day 1 through Day 366

  32. Occurrence of study vaccine-related serious adverse events following pIIV vaccination for Group 5

    Measured: Day 29 through Day 394

  33. Occurrence of study vaccine-related unsolicited non-serious adverse events following pIIV vaccination

    Measured: Day 29

  34. Occurrence of study vaccine-related unsolicited non-serious adverse events following pIIV vaccination for Group 5

    Measured: Day 57

  35. Occurrence of systemic reactogenicity following pIIV vaccination

    Measured: Day 1 through Day 8

  36. Occurrence of systemic reactogenicity following pIIV vaccination for Group 5

    Measured: Day 29 through Day 36

  37. Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H7N9 antigen contained in the study vaccine

    Measured: Day 1

  38. Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H7N9 antigen contained in the study vaccine

    Measured: Day 29

  39. Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H7N9 antigen contained in the study vaccine for Group 1, 5

    Measured: Day 209

  40. Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H7N9 antigen contained in the study vaccine for Group 1, 5

    Measured: Day 85

  41. Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H7N9 antigen contained in the study vaccine for Group 2

    Measured: Day 141

  42. Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H7N9 antigen contained in the study vaccine for Group 2

    Measured: Day 265

  43. Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H7N9 antigen contained in the study vaccine for Group 3

    Measured: Day 225

  44. Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H7N9 antigen contained in the study vaccine for Group 3

    Measured: Day 349

  45. Percentage of subjects achieving a serum NtAb titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines

    Measured: Day 1

  46. Percentage of subjects achieving a serum NtAb titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines

    Measured: Day 29

  47. Percentage of subjects achieving a serum NtAb titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines for Group 2

    Measured: Day 113

  48. Percentage of subjects achieving a serum NtAb titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines for Group 2

    Measured: Day 141

  49. Percentage of subjects achieving a serum NtAb titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines for Group 2

    Measured: Day 265

  50. Percentage of subjects achieving a serum NtAb titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines for Group 3

    Measured: Day 197

  51. Percentage of subjects achieving a serum NtAb titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines for Group 3

    Measured: Day 225

  52. Percentage of subjects achieving a serum NtAb titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines for Group 3

    Measured: Day 349

  53. Percentage of subjects achieving a serum NtAb titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines for Groups 1, 5

    Measured: Day 209

  54. Percentage of subjects achieving a serum NtAb titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines for Groups 1, 5

    Measured: Day 57

  55. Percentage of subjects achieving a serum NtAb titer of 1:40 or greater against the H7N9 antigen contained in the study vaccines for Groups 1, 5

    Measured: Day 85

  56. Percentage of subjects achieving seroconversion (a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer = / > 1:40 or a pre-vaccination HAI titer = / > 1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer)

    Measured: Day 29

  57. Percentage of subjects achieving seroconversion (a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer = / > 1:40 or a pre-vaccination HAI titer = / > 1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer) for Group 2

    Measured: Day 141

  58. Percentage of subjects achieving seroconversion (a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer = / > 1:40 or a pre-vaccination HAI titer = / > 1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer) for Group 2

    Measured: Day 265

  59. Percentage of subjects achieving seroconversion (a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer = / > 1:40 or a pre-vaccination HAI titer = / > 1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer) for Group 3

    Measured: Day 225

  60. Percentage of subjects achieving seroconversion (a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer = / > 1:40 or a pre-vaccination HAI titer = / > 1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer) for Group 3

    Measured: Day 349

  61. Percentage of subjects achieving seroconversion (a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer = / > 1:40 or a pre-vaccination HAI titer = / > 1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer) for Groups 1, 5

    Measured: Day 209

  62. Percentage of subjects achieving seroconversion (a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer = / > 1:40 or a pre-vaccination HAI titer = / > 1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer) for Groups 1, 5

    Measured: Day 85

  63. Percentage of subjects achieving seroconversion (a pre-vaccination NtAb titer <1:10 and a post-vaccination NtAb titer = / > 1:40 or a pre-vaccination NtAb titer = / > 1:10 and a minimum 4-fold rise in post-vaccination NtAb titer)

    Measured: Day 29

  64. Percentage of subjects achieving seroconversion (a pre-vaccination NtAb titer <1:10 and a post-vaccination NtAb titer = / > 1:40 or a pre-vaccination NtAb titer = / > 1:10 and a minimum 4-fold rise in post-vaccination NtAb titer) for Group 2

    Measured: Day 113

  65. Percentage of subjects achieving seroconversion (a pre-vaccination NtAb titer <1:10 and a post-vaccination NtAb titer = / > 1:40 or a pre-vaccination NtAb titer = / > 1:10 and a minimum 4-fold rise in post-vaccination NtAb titer) for Group 2

    Measured: Day 141

  66. Percentage of subjects achieving seroconversion (a pre-vaccination NtAb titer <1:10 and a post-vaccination NtAb titer = / > 1:40 or a pre-vaccination NtAb titer = / > 1:10 and a minimum 4-fold rise in post-vaccination NtAb titer) for Group 2

    Measured: Day 265

  67. Percentage of subjects achieving seroconversion (a pre-vaccination NtAb titer <1:10 and a post-vaccination NtAb titer = / > 1:40 or a pre-vaccination NtAb titer = / > 1:10 and a minimum 4-fold rise in post-vaccination NtAb titer) for Group 3

    Measured: Day 197

  68. Percentage of subjects achieving seroconversion (a pre-vaccination NtAb titer <1:10 and a post-vaccination NtAb titer = / > 1:40 or a pre-vaccination NtAb titer = / > 1:10 and a minimum 4-fold rise in post-vaccination NtAb titer) for Group 3

    Measured: Day 225

  69. Percentage of subjects achieving seroconversion (a pre-vaccination NtAb titer <1:10 and a post-vaccination NtAb titer = / > 1:40 or a pre-vaccination NtAb titer = / > 1:10 and a minimum 4-fold rise in post-vaccination NtAb titer) for Group 3

    Measured: Day 349

  70. Percentage of subjects achieving seroconversion (a pre-vaccination NtAb titer <1:10 and a post-vaccination NtAb titer = / > 1:40 or a pre-vaccination NtAb titer = / > 1:10 and a minimum 4-fold rise in post-vaccination NtAb titer) for Groups 1, 5

    Measured: Day 209

  71. Percentage of subjects achieving seroconversion (a pre-vaccination NtAb titer <1:10 and a post-vaccination NtAb titer = / > 1:40 or a pre-vaccination NtAb titer = / > 1:10 and a minimum 4-fold rise in post-vaccination NtAb titer) for Groups 1, 5

    Measured: Day 57

  72. Percentage of subjects achieving seroconversion (a pre-vaccination NtAb titer <1:10 and a post-vaccination NtAb titer = / > 1:40 or a pre-vaccination NtAb titer = / > 1:10 and a minimum 4-fold rise in post-vaccination NtAb titer) for Groups 1, 5

    Measured: Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2014 (estimated)
  2. Study start18 May 2015
  3. Primary completion17 Aug 2018
  4. Study completion17 Aug 2018

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02251288
Sponsor's protocol ID
13-0087
Status last verified
1 Jul 2018
First submitted
25 Sep 2014
Last updated
27 Jan 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca, Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 and MF59 adjuvant in people with Avian Influenza and Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 14 inclusion and 40 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Geometric mean titers determined by neuraminidase inhibiting antibody by enzyme-linked lectin assay (ELLA) (time frame: Day 29). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02251288.

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 27 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in