InfluenzaPhase 1NCT02665871
Safety Study of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in Chinese Adults Aged 3 Years and Older
A Phase 1 study testing one dose of Influenza Vaccine in people with Influenza, run by Beijing Chaoyang District Centre for Disease Control and Prevention.
Trial summary
This study evaluates the safety of freeze-dried live attenuated influenza vaccine for intranasal administration in chinese adults aged 3 years and older.80 subjects will be divided into 2 groups, including 18 years and older and 3-17 years old. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- one dose of Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2016
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy subjects more than 3 years
- Guardian and/or subjects aged at least 10 subjects can be informed consent, and sign a written Informed Consent Form.
- Subjects, Guardians and his family can obey the demands of the scheme .
- Axillary temperature less than 37℃
Who cannot join
- Subjects with flu or infected with flu within 3 months.
- Subjects have a vaccine allergies, allergic to any kind of composition in experimental vaccine, such as eggs, ovalbumin etc.
- Subjects have serious side effects to vaccine, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain.
- Subjects have symptoms of acute infection within a week.
- Subjects have autoimmune disease or immune function defect, Subjects have used immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months.
- Subjects have congenital malformations, developmental disorder or serious chronic diseases( such as Down's syndrome, diabetes, Sickle cell anemia or nerve system disease)
Show all 20Show fewer
- Subjects have asthma unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years.
- Subjects have medical history or family history of convulsions, seizures, encephalopathy and psychiatric disease.
- Alienia, functional asplenia, and alienia or splenectomy in any situation.
- Serious neurological disorders such as Green Barry syndrome.
- Subjects have received blood products or immunoglobulin products within 3 months before experimental vaccine inoculated.
- Subjects have received other study drug in the past month or received live vaccine, subunit vaccine or inactivated vaccine.
- The indicators of blood test or urine test do not conform to the inclusion criteria.
- Subjects have received allergy treatment in in the past 14 days.
- Subjects are receiving anti-tuberculosis treatment.
- Subjects have inoculated flu vaccine in the flu reason.
- Axillary temperature is more than 37℃ before vaccination.
- Subjects are pregnant or plan to become pregnant
- Subjects are participate in other clinical trials.
- Any factors unsuitable for clinical trail at the discretion of the investigator.
About this study
This study evaluates the safety of freeze-dried live attenuated influenza vaccine for intranasal administration in chinese adults aged 3 years and older.80 subjects will be divided into 2 groups, including 18 years and older and 3-17 years old. Subjects in each groups will randomly receive one dose of influenza vaccine or placebo in a 3:1 ratio.
- Conditions
- Influenza
- Being tested
- one dose of Influenza Vaccine, placebo
- Keywords
- vaccine, safety, intranasal administration
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one dose of Influenza VaccineBiological
one dose of Influenza VaccineBiological
placeboBiological
placeboBiological
| Study group | Role | What they receive |
|---|---|---|
| one dose of Influenza Vaccine in aged 18 years and older | Experimental | One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 18 years and older Receives: Biological: one dose of Influenza Vaccine |
| One dose of Influenza Vaccine in aged 3-17 year | Experimental | One dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 3-17 years Receives: Biological: one dose of Influenza Vaccine |
| placebo in aged 18 years and older | Placebo comparator | placebo in 10 subjects aged 18 years and older on day 0 Receives: Biological: placebo |
| placebo in aged 3-17 years | Placebo comparator | placebo in 10 subjects aged 3-17 years on day 0 Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the rate of adverse reactions of Live Attenuated Influenza Vaccine for Intranasal Administration
Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665871
- Sponsor's protocol ID
- cycdc2015-4
- Status last verified
- Jan 2016
- First submitted
- 21 Jan 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in Chinese Adults Aged 3 Years and Older
- ClinicalTrials.gov ID
- NCT02665871
- Acronym / sponsor ID
- cycdc2015-4
- Conditions
- Influenza
- Keywords
- vaccine, safety, intranasal administration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and PreventionUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (estimated)
- First posted
- 28 Jan 2016 (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 study evaluates the safety of freeze-dried live attenuated influenza vaccine for intranasal administration in chinese adults aged 3 years and older.80 subjects will be divided into 2 groups, including 18 years and older and 3-17 years old. Subjects in each groups will randomly receive one dose of influenza vaccine or placebo in a 3:1 ratio.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| one dose of Influenza Vaccine in aged 18 years and older | Experimental | Biological: one dose of Influenza VaccineOne dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 18 years and older |
| One dose of Influenza Vaccine in aged 3-17 year | Experimental | Biological: one dose of Influenza VaccineOne dose of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in aged 3-17 years |
| placebo in aged 18 years and older | Placebo comparator | Biological: placeboplacebo in 10 subjects aged 18 years and older on day 0 |
| placebo in aged 3-17 years | Placebo comparator | Biological: placeboplacebo in 10 subjects aged 3-17 years on day 0 |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects more than 3 years
- Guardian and/or subjects aged at least 10 subjects can be informed consent, and sign a written Informed Consent Form.
- Subjects, Guardians and his family can obey the demands of the scheme .
- Axillary temperature less than 37℃
Key exclusion criteria (20 listed)
- Subjects with flu or infected with flu within 3 months.
- Subjects have a vaccine allergies, allergic to any kind of composition in experimental vaccine, such as eggs, ovalbumin etc.
- Subjects have serious side effects to vaccine, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain.
- Subjects have symptoms of acute infection within a week.
- Subjects have autoimmune disease or immune function defect, Subjects have used immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months.
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 |
|---|---|---|
| one dose of Influenza Vaccine | Biological | one dose of Influenza Vaccine in aged 18 years and older |
| one dose of Influenza Vaccine | Biological | One dose of Influenza Vaccine in aged 3-17 year |
| placebo | Biological | placebo in aged 18 years and older |
| placebo | Biological | placebo in aged 3-17 years |
Primary outcome
Evaluate the rate of adverse reactions of Live Attenuated Influenza Vaccine for Intranasal Administration
Time frame: 3 months
Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing one dose of Influenza Vaccine in people with Influenza, run by Beijing Chaoyang District Centre for Disease Control and Prevention.
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 4 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Evaluate the rate of adverse reactions of Live Attenuated Influenza Vaccine for Intranasal Administration (time frame: 3 months). 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 15 Aug 2016.