Influenza A Virus, H7N9 SubtypePhase 1NCT02151344
Evaluating the Safety and Immune Response to a Live H7N9 Influenza Virus Vaccine Followed by an Inactivated H7N9 Influenza Virus Vaccine, Given at Varying Intervals
A Phase 1 study testing H7N9 A/Anhui/13 ca influenza virus vaccine and Inactivated subvirion H7N9 vaccine in people with Influenza A Virus, H7N9 Subtype, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying intervals. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A Virus, H7N9 Subtype
- What is being tested?
- H7N9 A/Anhui/13 ca influenza virus vaccine and Inactivated subvirion H7N9 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Feb 2015
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males and non-pregnant females between 18 years and 49 years of age, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, for safety considerations, and because of the need for isolation.
- General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
- Agree to storage of blood specimens for future research
- Available for the duration of the trial
- Willingness to participate in the study as evidenced by signing the informed consent document
- Female participants of childbearing potential must agree to use effective birth control methods for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse; surgical sterilization). All female participants will be considered being of childbearing potential except those who have undergone hysterectomy and those in whom menopause occurred at least 1 year prior to the study.
Who cannot join
- Pregnancy, as determined by a positive human choriogonadotropin (beta-HCG) test
- Currently breastfeeding
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing
- Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
- Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine
- Seropositive to the H7N9 influenza A virus (serum HAI titer greater than 1:8)
Show all 29Show fewer
- Positive urine drug toxicology test indicating narcotic use/dependency
- Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
- History of anaphylaxis
- Allergy to oseltamivir as determined by participant report
- Current diagnosis of asthma or reactive airway disease (within the past 2 years)
- History of Guillain-Barré Syndrome
- Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory test (e.g., Western blot or HIV-1/HIV-2 differentiation assay) for human immunodeficiency virus-1 (HIV-1)
- Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV)
- Positive hepatitis B virus surface antigen (HBsAg) by ELISA
- Known immunodeficiency syndrome
- Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination
- Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination
- History of asplenia
- Body mass index (BMI) greater than 40
- Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
- Current smoker unwilling to stop smoking for the duration of the study. More information on this criterion is available in the protocol.
- Travel to the Southern Hemisphere within 14 days prior to study vaccination
- Travel on a cruise ship within 14 days prior to study vaccination
- Receipt of another investigational vaccine or drug within 30 days prior to study vaccination
- History of hypersensitivity to any component of the investigational product including egg or egg protein, or serious, life threatening, or severe reactions to previous influenza vaccinations
- Individuals who use intranasal medications chronically
- Receipt of antiviral therapy or antiviral agents within 48 hours prior to receipt of investigational product
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21205
About this study
Official title: Phase 1 Evaluation of the Optimal Interval Between Priming With a Live Influenza A Vaccine H7N9 (6-2) AA ca Recombinant (A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H7N9 Disease Followed by Boost With a Non-adjuvanted Inactivated H7N9 Influenza Vaccine
H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying intervals.
Read the detailed description
H7N9 avian influenza (AI) viruses have been responsible for a recent outbreak of illness in humans in China, which was associated with severe respiratory illnesses resulting in acute respiratory distress syndrome (ARDS) and intensive care unit (ICU) admissions. The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a live attenuated H7N9 A/Anhui/13 cold adapted (ca) influenza virus vaccine followed by a boost with an inactivated subvirion H7N9 vaccine at varying intervals.
This study will enroll participants into five cohorts. Participants in Cohorts 1, 2, 3, and 4 will be admitted to an isolation unit on Study Day -2. On Study Day 0, participants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine via a nose spray device. While in the isolation unit, participants will undergo a physical examination and nasal wash each day, and a blood collection on select days. Participants will remain in the isolation unit for at least 9 days after receiving the vaccine, but possibly longer, depending on their test results.
Participants in Cohorts 1 and 2 will return to the isolation unit 4 to 8 weeks after receiving the first vaccine (at approximately Day 28). They will receive the second dose of the H7N9 A/Anhui/13 ca influenza virus vaccine and repeat all of the same procedures that occurred after the first vaccination.
Participants will then receive one dose of the inactivated subvirion H7N9 vaccine 1 month (Cohort 1) or 2 months (Cohort 2) after receiving the second vaccine.
Participants in Cohorts 3 and 4 will receive the inactivated subvirion H7N9 vaccine either 1 month (Cohort 4) or 2 months (Cohort 3) after receiving one dose of the live attenuated vaccine. For Cohorts 1-4, participants study visits will occur 7, 14, 28, and 90 days after receiving the vaccine and will include a medical history review, physical examination, and blood collection at select visits.
Participants in Cohort 5 will receive one dose of the inactivated subvirion H7N9 vaccine at Day 0 and one dose at Day 28. Study visits will occur on Days 0, 7, 28, 35, 42, 56, and 118, and will include blood collections and physical examinations. Participants in Cohort 5 will not be admitted to the isolation unit.
- Conditions
- Influenza A Virus, H7N9 Subtype
- Being tested
- H7N9 A/Anhui/13 ca influenza virus vaccine, Inactivated subvirion H7N9 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H7N9 A/Anhui/13 ca influenza virus vaccineBiological
Participants will receive approximately 10^7.0 fluorescent focus units (FFU) of the vaccine; the vaccine will be administered with a nose spray device.
Inactivated subvirion H7N9 vaccineBiological
Participants will receive a dose of 30 mcg of the vaccine; the vaccine will be administered as an injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine at Day 0 and one dose at Day 28. They will then receive one dose of the inactivated subvirion H7N9 vaccine 1 month later. Receives: Biological: H7N9 A/Anhui/13 ca influenza virus vaccine; Biological: Inactivated subvirion H7N9 vaccine |
| Cohort 2 | Experimental | Participants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine at Day 0 and one dose at Day 28. They will then receive one dose of the inactivated subvirion H7N9 vaccine 2 months later. Receives: Biological: H7N9 A/Anhui/13 ca influenza virus vaccine; Biological: Inactivated subvirion H7N9 vaccine |
| Cohort 3 | Experimental | Participants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine at Day 0. They will then receive one dose of the inactivated subvirion H7N9 vaccine 2 months later. Receives: Biological: H7N9 A/Anhui/13 ca influenza virus vaccine; Biological: Inactivated subvirion H7N9 vaccine |
| Cohort 4 | Experimental | Participants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine at Day 0. They will then receive one dose of the inactivated subvirion H7N9 vaccine 1 month later. Receives: Biological: H7N9 A/Anhui/13 ca influenza virus vaccine; Biological: Inactivated subvirion H7N9 vaccine |
| Cohort 5 | Experimental | Participants will receive one dose of the inactivated subvirion H7N9 vaccine at Day 0 and one dose at Day 28. Receives: Biological: Inactivated subvirion H7N9 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the ability of the pLAIV vaccine to induce priming by assessing the response to a subsequent dose of pIIV
Measured: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Measurement of the optimal interval between the priming with pLAIV and the subsequent boost with pIIV
Measured: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Determination of whether 1 dose or 2 doses of pLAIV followed by a pIIV boost is sufficient to induce an optimal immune response
Measured: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Frequency of vaccine-related reactogenicity events (REs) for 2 doses of pLAIV vaccine followed by a single dose of inactivated pIIV and compare to 2 doses of pIIV alone
Measured: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Frequency of other adverse events (AEs) for 2 doses of pLAIV vaccine followed by a single dose of inactivated pIIV and compare to 2 doses of pIIV alone
Measured: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Secondary outcomes (4)
Number of vaccinees infected with the H7N9 Anhui 2013/AA ca recombinant vaccine candidate
Infection is defined as recovery of vaccine virus from nasal wash, detection of virus in nasal wash by rRT-PCR, and/or a greater than or equal to 4-fold rise in antibody titer.
Measured: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Measurement of the amount of vaccine virus shed by each recipient
Measured: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Measurement of amount of serum and nasal wash antibody induced by the vaccine
Measured: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Capacity of the H7N9 Anhui 2013/AA ca recombinant vaccine candidate to elicit HAI and neutralizing antibodies to future H7 influenza viruses
Includes the development of a serum bank
Measured: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza A Virus, H7N9 SubtypeStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kawsar Talaat, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151344
- Sponsor's protocol ID
- CIR 293
- Status last verified
- Mar 2015
- First submitted
- 28 May 2014
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Evaluation of the Optimal Interval Between Priming With a Live Influenza A Vaccine H7N9 (6-2) AA ca Recombinant (A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H7N9 Disease Followed by Boost With a Non-adjuvanted Inactivated H7N9 Influenza Vaccine
- ClinicalTrials.gov ID
- NCT02151344
- Acronym / sponsor ID
- CIR 293
- Conditions
- Influenza A Virus, H7N9 Subtype
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 May 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.
H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying intervals.
Detailed description
H7N9 avian influenza (AI) viruses have been responsible for a recent outbreak of illness in humans in China, which was associated with severe respiratory illnesses resulting in acute respiratory distress syndrome (ARDS) and intensive care unit (ICU) admissions. The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a live attenuated H7N9 A/Anhui/13 cold adapted (ca) influenza virus vaccine followed by a boost with an inactivated subvirion H7N9 vaccine at varying intervals.
This study will enroll participants into five cohorts. Participants in Cohorts 1, 2, 3, and 4 will be admitted to an isolation unit on Study Day -2. On Study Day 0, participants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine via a nose spray device. While in the isolation unit, participants will undergo a physical examination and nasal wash each day, and a blood collection on select days. Participants will remain in the isolation unit for at least 9 days after receiving the vaccine, but possibly longer, depending on their test results.
Participants in Cohorts 1 and 2 will return to the isolation unit 4 to 8 weeks after receiving the first vaccine (at approximately Day 28). They will receive the second dose of the H7N9 A/Anhui/13 ca influenza virus vaccine and repeat all of the same procedures that occurred after the first vaccination.
Participants will then receive one dose of the inactivated subvirion H7N9 vaccine 1 month (Cohort 1) or 2 months (Cohort 2) after receiving the second vaccine.
Participants in Cohorts 3 and 4 will receive the inactivated subvirion H7N9 vaccine either 1 month (Cohort 4) or 2 months (Cohort 3) after receiving one dose of the live attenuated vaccine. For Cohorts 1-4, participants study visits will occur 7, 14, 28, and 90 days after receiving the vaccine and will include a medical history review, physical examination, and blood collection at select visits.
Participants in Cohort 5 will receive one dose of the inactivated subvirion H7N9 vaccine at Day 0 and one dose at Day 28. Study visits will occur on Days 0, 7, 28, 35, 42, 56, and 118, and will include blood collections and physical examinations. Participants in Cohort 5 will not be admitted to the isolation unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: H7N9 A/Anhui/13 ca influenza virus vaccine, Biological: Inactivated subvirion H7N9 vaccineParticipants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine at Day 0 and one dose at Day 28. They will then receive one dose of the inactivated subvirion H7N9 vaccine 1 month later. |
| Cohort 2 | Experimental | Biological: H7N9 A/Anhui/13 ca influenza virus vaccine, Biological: Inactivated subvirion H7N9 vaccineParticipants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine at Day 0 and one dose at Day 28. They will then receive one dose of the inactivated subvirion H7N9 vaccine 2 months later. |
| Cohort 3 | Experimental | Biological: H7N9 A/Anhui/13 ca influenza virus vaccine, Biological: Inactivated subvirion H7N9 vaccineParticipants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine at Day 0. They will then receive one dose of the inactivated subvirion H7N9 vaccine 2 months later. |
| Cohort 4 | Experimental | Biological: H7N9 A/Anhui/13 ca influenza virus vaccine, Biological: Inactivated subvirion H7N9 vaccineParticipants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine at Day 0. They will then receive one dose of the inactivated subvirion H7N9 vaccine 1 month later. |
| Cohort 5 | Experimental | Biological: Inactivated subvirion H7N9 vaccineParticipants will receive one dose of the inactivated subvirion H7N9 vaccine at Day 0 and one dose at Day 28. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult males and non-pregnant females between 18 years and 49 years of age, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, for safety considerations, and because of the need for isolation.
- General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
- Agree to storage of blood specimens for future research
- Available for the duration of the trial
- Willingness to participate in the study as evidenced by signing the informed consent document
Key exclusion criteria (29 listed)
- Pregnancy, as determined by a positive human choriogonadotropin (beta-HCG) test
- Currently breastfeeding
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing
- Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
- Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine
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 |
|---|---|---|
| H7N9 A/Anhui/13 ca influenza virus vaccineParticipants will receive approximately 10^7.0 fluorescent focus units (FFU) of the vaccine; the vaccine will be administered with a nose spray device. | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| Inactivated subvirion H7N9 vaccineParticipants will receive a dose of 30 mcg of the vaccine; the vaccine will be administered as an injection. | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Measurement of the ability of the pLAIV vaccine to induce priming by assessing the response to a subsequent dose of pIIV
Time frame: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Measurement of the optimal interval between the priming with pLAIV and the subsequent boost with pIIV
Time frame: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Determination of whether 1 dose or 2 doses of pLAIV followed by a pIIV boost is sufficient to induce an optimal immune response
Time frame: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Frequency of vaccine-related reactogenicity events (REs) for 2 doses of pLAIV vaccine followed by a single dose of inactivated pIIV and compare to 2 doses of pIIV alone
Time frame: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Frequency of other adverse events (AEs) for 2 doses of pLAIV vaccine followed by a single dose of inactivated pIIV and compare to 2 doses of pIIV alone
Time frame: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
4 secondary outcomes
Number of vaccinees infected with the H7N9 Anhui 2013/AA ca recombinant vaccine candidate
Time frame: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Measurement of the amount of vaccine virus shed by each recipient
Time frame: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Measurement of amount of serum and nasal wash antibody induced by the vaccine
Time frame: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Capacity of the H7N9 Anhui 2013/AA ca recombinant vaccine candidate to elicit HAI and neutralizing antibodies to future H7 influenza viruses
Time frame: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
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 30 Mar 2015.
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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.
Kawsar Talaat, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H7N9 A/Anhui/13 ca influenza virus vaccine and Inactivated subvirion H7N9 vaccine in people with Influenza A Virus, H7N9 Subtype, 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 6 inclusion and 29 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 30 Mar 2015. 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?
Measurement of the ability of the pLAIV vaccine to induce priming by assessing the response to a subsequent dose of pIIV (time frame: Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)). The study lists 5 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 30 Mar 2015.