Avian InfluenzaPhase 2NCT02213354
H7N9 Mix and Match With MF59 in Healthy Elderly Persons
A Phase 2 study testing MF59 and Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 in people with Avian Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
Trial summary
This is a Phase II randomized, partially-blinded, controlled trial in 360 (up to 600) males and females, 65 years of age and older, who are in good health and meet all eligibility criteria. Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Avian Influenza
- What is being tested?
- MF59 and Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2014to Jul 2016
- Phase
- Phase 2
- 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 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Provide written informed consent prior to initiation of any study procedures.
- Are able to understand and comply with planned study procedures and be available for all study visits.
- Are males or females, 65 years of age and older.
- Are in good health1. 1As determined by medical history and targeted physical examination, if indicated based on medical history, to evaluate acute or currently ongoing chronic medical diagnoses or conditions that would affect the assessment of eligibility and safety of subjects. Chronic medical diagnoses or conditions being actively managed must be within acceptable limits in the last 180 days. Good health in the elderly is also defined as no change in chronic prescription medication, dose, or frequency of medication in the 90 days prior to enrollment. Any prescription 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 deviation 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 deviation 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 and does not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and first study vaccination are acceptable provided the subject is asymptomatic, condition stable, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of steroids as outlined in the Subject Exclusion Criteria (see Section 5.2)), herbals, vitamins, and supplements are permitted
- Oral temperature is less than 100.0 degrees F.
- Pulse is 50 to 115 bpm, inclusive.
- Systolic blood pressure is 85 to 160 mm Hg, inclusive.
- Diastolic blood pressure is 55 to 95 mm Hg, inclusive
Who cannot join
- 1. Have an acute illness2, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination.
- 2An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
- 2. Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation3.
- 3Including acute or chronic medical disease or condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study.
- 3. Reside in a nursing home4 or other skilled nursing facility or have a requirement for skilled nursing care.
- 4An ambulatory subject who does not require skilled nursing care and is a resident of a retirement home or community is eligible for this clinical trial.
Show all 27Show fewer
- 4. Inability to provide informed consent or complete study activities, for example, due to dementia or other impairment.
- 5. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
- 6. Have known active neoplastic disease or a history of any hematologic malignancy.
- 7. Have known HIV, hepatitis B, or hepatitis C infection. 8. Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.
- 9. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.
- 10. Have a history of Guillain-Barré Syndrome. 11. Have a history of neuralgia, paresthesia, neuritis, convulsions, or encephalomyelitis within 90 days prior to study vaccination.
- 12. Have a history of autoimmune disease5. 5Including, but not limited to, autoimmune processes resulting in neuroinflammatory diseases, vasculitis, clotting disorders, dermatitis, arthritis, thyroiditis, or muscle, liver, or kidney disease.
- 13. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
- 14. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
- 15. 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.
- 16. Have taken oral or parenteral corticosteroids of any dose within 30 days prior to study vaccination.
- 17. Have taken high-dose inhaled corticosteroidswithin 30 days prior to study vaccination. High-dose defined as >800 mcg/day of beclomethasone dipropionate CFC or equivalent.
- 18. Received a licensed live vaccine within 30 days prior to enrollment in this study, or plans to receive a licensed live vaccine within 30 days before or after each study vaccine.
- 19. Received a licensed inactivated vaccine within 14 days prior to enrollment in this study, or plans to receive a licensed inactivated vaccine within 14 days before or after each study vaccine.
- 20. Received immunoglobulin or other blood products within 90 days prior to study vaccination.
- 21. Received an experimental agent6 within 30 days prior to the first study vaccination, or expects to receive an experimental agent7 during the 18-month study period.
- 6Including vaccine, drug, biologic, device, blood product, or medication. 7Other than from participation in this study. 22. Are participating or plan to participate in another clinical trial with an interventional agent8 during the 18-month study period.
- 8 Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.
- 23. Prior participation in a clinical trial of influenza A/H7 vaccine9 or have a history of A/H7 actual or potential exposure or infection prior to the first study vaccination.
- 9And assigned to a group receiving influenza A/H7 vaccine, does not apply to documented placebo recipients.
- 24. Plan to travel outside the US (continental US, Hawaii, and Alaska) within the 28 days following each study vaccination.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201-1509
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, 45229-3026
Emory Vaccine Center - The Hope Clinic
Decatur, Georgia, 30030-1705
Duke Human Vaccine Institute - Duke Clinical Vaccine Unit
Durham, North Carolina, 27704
University of Texas Medical Branch - Sealy Center for Vaccine Development - Clinical Trials Group
Galveston, Texas, 77555-1119
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, 77030-3411
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, 52242-2600
Vanderbilt University Medical Center - Vanderbilt Institute for Clinical and Translational Research - Clinical Research Center (VICTR-CRC)
Nashville, Tennessee, 37232-0011
Group Health Research Institute - Seattle - Vaccines and Infectious Diseases
Seattle, Washington, 98101-1466
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, 63104-1015
About this study
Official title: A Phase II Randomized, Partially-Blinded, Controlled Trial in Healthy Adults Aged 65 Years and Older to Assess the Safety, Reactogenicity, and Immunogenicity of an MF59-Adjuvanted, Monovalent Inactivated Influenza A/H7N9 Virus Vaccine Administered Intramuscularly at Different Intervals and Dosages
This is a Phase II randomized, partially-blinded, controlled trial in 360 (up to 600) males and females, 65 years of age and older, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H7N9 virus vaccine manufactured by Sanofi Pasteur administered intramuscularly at different intervals and dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with MF59 adjuvant manufactured by Novartis Vaccines and Diagnostics. Subjects will receive three doses of the vaccine. Safety, reactogenicity, and immunogenicity data will be collected at standard time points with safety follow-up to continue through one year post dose 2. Study Duration is approximately 30 months and Subject Participation is approximately 18 months. The primary objectives are to (1) assess the safety and reactogenicity of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuv
Read the detailed description
This is a Phase II randomized, partially-blinded, controlled trial in males and females, 65 years of age and older, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H7N9 virus vaccine, derived from the influenza A/Shanghai/2/2013 virus, manufactured by Sanofi Pasteur administered intramuscularly at different intervals and dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with MF59 adjuvant manufactured by Novartis Vaccines and Diagnostics. Subjects will be assigned randomly to 1 of 6 groups (60 to 100 subjects per group) to receive three doses intramuscularly of the inactivated A/H7N9 vaccine at dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with MF59 adjuvant using two different study vaccination schedules. The first and third study vaccinations will be administered to all subjects on Day 1 and approximately Day 169. The second study vaccination will be administered either on approximately Day 29 for Groups 1, 3, and 5 or approximately Day 57 for Groups 2, 4, and 6. Reactogenicity will be measured from the time of each study vaccination through 8 days after each study vaccination by the occurrence of solicited injection site and systemic reactions. Unsolicited non-serious adverse events (AEs) will be collected from the time of each study vaccination through approximately 28 days after each study vaccination. Serious adverse events (SAEs) and new-onset chronic medical conditions will be collected from the time of the first study vaccination through approximately 12 months after the last study vaccination.
Immunogenicity testing will include performing hemagglutination inhibition (HAI) and neutralizing (Neut) antibody assays on serum obtained immediately prior to the first study vaccination (Day 1), approximately 28 days after the second study vaccination (approximately Day 57 for Groups 1, 3, and 5; approximately Day 85 for Groups 2, 4, and 6), immediately prior to the third study vaccination (approximately Day 169), and approximately 28 days after the third study vaccination (approximately Day 197). Subjects in Groups 1, 3, and 5 will also have immunogenicity testing for HAI and Neut antibody assays performed on serum obtained at approximately 56 days after the second study vaccination (approximately Day 85). Between 360 and 600 subjects will be enrolled in this trial. Study Duration is approximately 30 months and Subject Participation is approximately 18 months. The primary objectives are to (1) assess the safety and reactogenicity of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuvanted, monovalent inactivated influenza A/H7N9 virus vaccine using two different study vaccination schedules and (2) assess the serum hemagglutination inhibition (HAI) antibody responses to different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuvanted, monovalent inactivated influenza A/H7N9 virus vaccine using two different study vaccination schedules following receipt of the second study vaccination. The secondary obectives are to (1) assess study vaccine-related unsolicited non-serious adverse events following receipt of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuvanted, monovalent inactivated influenza A/H7N9 virus vaccine using two different study vaccination schedules, (2) assess new-onset chronic medical conditions following receipt of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuvanted, monovalent inactivated influenza A/H7N9 virus vaccine using two different study vaccination sched
- Conditions
- Avian Influenza
- Being tested
- MF59, Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
- Keywords
- Influenza, H7N9, Elderly, Vaccine, MF59 Adjuvant
- Medical subject headings
- Influenza in Birds, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF59Drug
Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion. Group 1-6 receive 3.75 mcg, 7.5 mcg and 15 mcg.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013Biological
Monovalent inactivated split influenza virus vaccine made with HA antigen derived from the influenza A/Shanghai/2/2013 virus. Monovalent influenza A/H7N9 virus vaccine. Group 1-6 receive 3.75 mcg, 7.5 mcg and 15 mcg.
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Experimental | 60 subjects receive Sanofi A/H7N9 antigen 3.75 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 57, and Day 169 Receives: Drug: MF59; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 |
| Group 6 | Experimental | 60 subjects receive Sanofi A/H7N9 antigen 15 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 57, and Day 169 Receives: Drug: MF59; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 |
| Group 5 | Experimental | 60 subjects receive Sanofi A/H7N9 antigen 15 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 29 and Day 169 Receives: Drug: MF59; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 |
| Group 4 | Experimental | 60 subjects receive Sanofi A/H7N9 antigen 7.5 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 57, and Day 169 Receives: Drug: MF59; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 |
| Group I | Experimental | 60 subjects receive Sanofi A/H7N9 antigen 3.75 mcg plus Novartis MF59 adjuvant intramuscularly (IM) on Day 1, Day 29 and Day 169 Receives: Drug: MF59; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 |
| Group 3 | Experimental | 60 subjects receive Sanofi A/H7N9 antigen 7.5 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 29 and Day 169 Receives: Drug: MF59; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine
Measured: 28 days after the second study vaccination
Percent of subjects achieving HAI seroconversion against the A/H7N9 antigen contained in the study vaccine (either a pre-vaccine HAI titer < 1:10 and a post-vaccine HAI titer > /= 1:40 or a pre-vaccine HAI titer > /=1:10 and a min 4-fold rise in post-vac
Measured: 28 days after the second study vaccination
Occurrence of study vaccine-related serious adverse events
Measured: Through Day 1 to 12 months after the last study vaccination
Occurrence of solicited injection site and systemic reactogenicity events
Measured: Through 8 days after each study vaccination
Secondary outcomes (7)
Occurrence of study vaccine-related unsolicited non-serious adverse events
Measured: 28 days after each study vaccination
Occurrence of new-onset chronic medical conditions
Measured: Through Day 1 to 12 months after the last study vaccination
Percentage of subjects achieving Neut seroconversion against A/H7N9 antigen (either prevaccination Neut titer < 1:10 and postvaccination Neut titer > /=1:40 or prevaccination Neut titer > /=1:10 and minimum fourfold rise in post-vaccination Neut
Measured: 28 days after the second and third study vaccinations
Geometric Mean Titers of serum HAI and Neut antibodies against the A/H7N9 antigen
Measured: Baseline and 28 days after the second and third study vaccinations
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine
Measured: Baseline and 28 days after the third study vaccination
Percentage of subjects achieving a serum Neut antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine
Measured: Baseline and 28 days after the second and third study vaccinations
Percentage of subjects achieving HAI seroconversion against the A/H7N9 antigen
Measured: 28 days after the third study vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avian InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213354
- Sponsor's protocol ID
- 13-0034
- Other IDs
- HHSN272201300016I
- Status last verified
- Apr 2016
- First submitted
- 7 Aug 2014
- Last updated
- 6 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Partially-Blinded, Controlled Trial in Healthy Adults Aged 65 Years and Older to Assess the Safety, Reactogenicity, and Immunogenicity of an MF59-Adjuvanted, Monovalent Inactivated Influenza A/H7N9 Virus Vaccine Administered Intramuscularly at Different Intervals and Dosages
- ClinicalTrials.gov ID
- NCT02213354
- Acronym / sponsor ID
- 13-0034
- Conditions
- Avian Influenza
- Keywords
- Influenza, H7N9, Elderly, Vaccine, MF59 Adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II randomized, partially-blinded, controlled trial in 360 (up to 600) males and females, 65 years of age and older, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H7N9 virus vaccine manufactured by Sanofi Pasteur administered intramuscularly at different intervals and dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with MF59 adjuvant manufactured by Novartis Vaccines and Diagnostics. Subjects will receive three doses of the vaccine. Safety, reactogenicity, and immunogenicity data will be collected at standard time points with safety follow-up to continue through one year post dose 2. Study Duration is approximately 30 months and Subject Participation is approximately 18 months. The primary objectives are to (1) assess the safety and reactogenicity of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuv
Detailed description
This is a Phase II randomized, partially-blinded, controlled trial in males and females, 65 years of age and older, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H7N9 virus vaccine, derived from the influenza A/Shanghai/2/2013 virus, manufactured by Sanofi Pasteur administered intramuscularly at different intervals and dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with MF59 adjuvant manufactured by Novartis Vaccines and Diagnostics. Subjects will be assigned randomly to 1 of 6 groups (60 to 100 subjects per group) to receive three doses intramuscularly of the inactivated A/H7N9 vaccine at dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with MF59 adjuvant using two different study vaccination schedules. The first and third study vaccinations will be administered to all subjects on Day 1 and approximately Day 169. The second study vaccination will be administered either on approximately Day 29 for Groups 1, 3, and 5 or approximately Day 57 for Groups 2, 4, and 6. Reactogenicity will be measured from the time of each study vaccination through 8 days after each study vaccination by the occurrence of solicited injection site and systemic reactions. Unsolicited non-serious adverse events (AEs) will be collected from the time of each study vaccination through approximately 28 days after each study vaccination. Serious adverse events (SAEs) and new-onset chronic medical conditions will be collected from the time of the first study vaccination through approximately 12 months after the last study vaccination.
Immunogenicity testing will include performing hemagglutination inhibition (HAI) and neutralizing (Neut) antibody assays on serum obtained immediately prior to the first study vaccination (Day 1), approximately 28 days after the second study vaccination (approximately Day 57 for Groups 1, 3, and 5; approximately Day 85 for Groups 2, 4, and 6), immediately prior to the third study vaccination (approximately Day 169), and approximately 28 days after the third study vaccination (approximately Day 197). Subjects in Groups 1, 3, and 5 will also have immunogenicity testing for HAI and Neut antibody assays performed on serum obtained at approximately 56 days after the second study vaccination (approximately Day 85). Between 360 and 600 subjects will be enrolled in this trial. Study Duration is approximately 30 months and Subject Participation is approximately 18 months. The primary objectives are to (1) assess the safety and reactogenicity of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuvanted, monovalent inactivated influenza A/H7N9 virus vaccine using two different study vaccination schedules and (2) assess the serum hemagglutination inhibition (HAI) antibody responses to different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuvanted, monovalent inactivated influenza A/H7N9 virus vaccine using two different study vaccination schedules following receipt of the second study vaccination. The secondary obectives are to (1) assess study vaccine-related unsolicited non-serious adverse events following receipt of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuvanted, monovalent inactivated influenza A/H7N9 virus vaccine using two different study vaccination schedules, (2) assess new-onset chronic medical conditions following receipt of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuvanted, monovalent inactivated influenza A/H7N9 virus vaccine using two different study vaccination sched
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Experimental | Drug: MF59, Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/201360 subjects receive Sanofi A/H7N9 antigen 3.75 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 57, and Day 169 |
| Group 6 | Experimental | Drug: MF59, Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/201360 subjects receive Sanofi A/H7N9 antigen 15 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 57, and Day 169 |
| Group 5 | Experimental | Drug: MF59, Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/201360 subjects receive Sanofi A/H7N9 antigen 15 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 29 and Day 169 |
| Group 4 | Experimental | Drug: MF59, Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/201360 subjects receive Sanofi A/H7N9 antigen 7.5 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 57, and Day 169 |
| Group I | Experimental | Drug: MF59, Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/201360 subjects receive Sanofi A/H7N9 antigen 3.75 mcg plus Novartis MF59 adjuvant intramuscularly (IM) on Day 1, Day 29 and Day 169 |
| Group 3 | Experimental | Drug: MF59, Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/201360 subjects receive Sanofi A/H7N9 antigen 7.5 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 29 and Day 169 |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent prior to initiation of any study procedures.
- Are able to understand and comply with planned study procedures and be available for all study visits.
- Are males or females, 65 years of age and older.
- Are in good health1. 1As determined by medical history and targeted physical examination, if indicated based on medical history, to evaluate acute or currently ongoing chronic medical diagnoses or conditions that would affect the assessment of eligibility and safety of subjects. Chronic medical diagnoses or conditions being actively managed must be within acceptable limits in the last 180 days. Good health in the elderly is also defined as no change in chronic prescription medication, dose, or frequency of medication in the 90 days prior to enrollment. Any prescription 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 deviation 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 deviation 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 and does not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and first study vaccination are acceptable provided the subject is asymptomatic, condition stable, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of steroids as outlined in the Subject Exclusion Criteria (see Section 5.2)), herbals, vitamins, and supplements are permitted
- Oral temperature is less than 100.0 degrees F.
Key exclusion criteria (27 listed)
- 1. Have an acute illness2, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination.
- 2An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
- 2. Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation3.
- 3Including acute or chronic medical disease or condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study.
- 3. Reside in a nursing home4 or other skilled nursing facility or have a requirement for skilled nursing care.
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 |
|---|---|---|
| MF59Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion. Group 1-6 receive 3.75 mcg, 7.5 mcg and 15 mcg. | Drug | Group 2, Group 3, Group 4, Group 5, Group 6, Group I |
| Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013Monovalent inactivated split influenza virus vaccine made with HA antigen derived from the influenza A/Shanghai/2/2013 virus. Monovalent influenza A/H7N9 virus vaccine. Group 1-6 receive 3.75 mcg, 7.5 mcg and 15 mcg. | Biological | Group 2, Group 3, Group 4, Group 5, Group 6, Group I |
Primary outcome
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine
Time frame: 28 days after the second study vaccination
Percent of subjects achieving HAI seroconversion against the A/H7N9 antigen contained in the study vaccine (either a pre-vaccine HAI titer < 1:10 and a post-vaccine HAI titer > /= 1:40 or a pre-vaccine HAI titer > /=1:10 and a min 4-fold rise in post-vac
Time frame: 28 days after the second study vaccination
Occurrence of study vaccine-related serious adverse events
Time frame: Through Day 1 to 12 months after the last study vaccination
Occurrence of solicited injection site and systemic reactogenicity events
Time frame: Through 8 days after each study vaccination
7 secondary outcomes
Occurrence of study vaccine-related unsolicited non-serious adverse events
Time frame: 28 days after each study vaccination
Occurrence of new-onset chronic medical conditions
Time frame: Through Day 1 to 12 months after the last study vaccination
Percentage of subjects achieving Neut seroconversion against A/H7N9 antigen (either prevaccination Neut titer < 1:10 and postvaccination Neut titer > /=1:40 or prevaccination Neut titer > /=1:10 and minimum fourfold rise in post-vaccination Neut
Time frame: 28 days after the second and third study vaccinations
Geometric Mean Titers of serum HAI and Neut antibodies against the A/H7N9 antigen
Time frame: Baseline and 28 days after the second and third study vaccinations
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine
Time frame: Baseline and 28 days after the third study vaccination
Percentage of subjects achieving a serum Neut antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine
Time frame: Baseline and 28 days after the second and third study vaccinations
Percentage of subjects achieving HAI seroconversion against the A/H7N9 antigen
Time frame: 28 days after the third study vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
Related trials for Avian Influenza
Active, not recruitingPhase 3
Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)
Influenza (Pandemic), Avian Influenza
Enrolling by invitationPhase 1
Rechallenge With a Low Pathogenicity Avian H10N7 Influenza Virus in Healthy Human Volunteers Previously Challenged With H10N7 Influenza
Influenza Infection, Infections
Active, not recruitingPhase 1/2
A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)
Influenza A
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
Active, not recruitingPhase 3
A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
Influenza
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.
The record lists no contact. Use the official record to reach the sponsor.
10 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 MF59 and Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 in people with Avian Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 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 8 inclusion and 27 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 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
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?
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine (time frame: 28 days after the second study vaccination). The study lists 4 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 Jul 2017.