Influenza PreventionPhase 1NCT05056519
The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine
A Phase 1 study testing Live Attenuated Influenza Vaccine in people with Influenza Prevention, run by Changchun BCHT Biotechnology Co. at 1 site in China.
Trial summary
Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase Ⅰ trail is to evaluate the safety of LAVI(non freeze-dried). Read more about this study
- Who is it for?
- Ages 3 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Prevention
- What is being tested?
- Live Attenuated Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2021to 30 Mar 2022
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy volunteers aged in 3-59 years old.
- Had not received vaccination of Influenza vaccine in the past half of years.
- Had not infected with Influenza virus.
- This trail has been agreed by volunteers or his/her legal guardian.
- Volunteers or his/her legal guardian will fellow this trail protocol.
Who cannot join
- People from 18-59 age group with abnormal laboratory index. (slight abnormality is except if judged with no clinical significance by doctors.)
- People with fever before vaccination, temperature higher than 37.0 ℃
- Females in suckling period, pregnancy (pregnancy test positive) or prepared to be pregnant
- People given whole blood, plasma or immunoglobulin therapy within 3 months before vaccination
- According to judgement of researchers, the subjects have any other factors that are not appropriate for this clinical trials.
- Acute infectious disease or acute attack of chronic disease before inoculation
Show all 9Show fewer
- People get any vaccine within 14 days before the trial.
- People in immune deficiency or diagnosed with congenital or acquired immunodeficiency, people with immunosuppressive therapy in the past six months.
- People with epilepsy or a history of mental illness
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, 050021
Yuliang Zhao, chief physician, +86-13315290538, yuliang_zh@163.com
About this study
Official title: A Random, Double -Blind, Placebo Control Phase Ⅰ Trail to Evaluate the Safety and Immunogenicity of Live Attenuated Influenza Vaccine in 3-59y Healthy People
Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase Ⅰ trail is to evaluate the safety of LAVI(non freeze-dried). The secondary objective is to evaluate the immunogenicity of LAVI(non freeze-dried).
Read the detailed description
Totally 160 health people aged 3-59 years old will be divided into two age group, containing 80 in 18-59 years old and 80 in 3-19 years old. All subjects will receive vaccination either LAVI or placebo in a ratio of 3:1.
All subjects will be collected any adverse events within 30 days and any serious adverse events within 6 months for safety evaluation.
All subjects will be collected blood sample and nasopharyngeal swab for immunogenicity evaluation.
- Conditions
- Influenza Prevention
- Being tested
- Live Attenuated Influenza Vaccine, Live Attenuated Influenza Vaccine placebo
- Keywords
- Safety, Immunogenicity, Live Attenuated Influenza Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Attenuated Influenza VaccineBiological
Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
Live Attenuated Influenza Vaccine placeboBiological
Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Healthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine Receives: Biological: Live Attenuated Influenza Vaccine |
| Placebo group | Placebo comparator | Healthy people in placebo group will receive a dose of placebo Receives: Biological: Live Attenuated Influenza Vaccine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as assessed by SAS v9.4
The incidence rate of adverse events in all subjects
Measured: Within 31 days after vaccination
Number of participants with laboratory examination abnormity as assessed by SAS v9.4Clinical laboratory examination
The incidence rate of abnormal of Blood routine, blood biochemical and urine in The incidence rate of abnormality of blood routine, blood biochemical and urine routine in 18-59 years age group
Measured: 3 days after vaccination
Number of participants with virus Shedding as assessed by SAS v9.4
The nasal secretions of Subjects in 18-59 years age group will be taken and be tested
Measured: within 16 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start20 Sep 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza PreventionStudies of the same condition, open and under way.
- More trials run by Changchun BCHT Biotechnology Co.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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Totally 160 in 3-59 years old healthy people will be divided into two age group, which contain 80 people in 18-59 years old and 80 people in 3-17 years old. In each age group, subjects will be randomly divided into vaccine group and placebo group in a ratio of 3:1.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- He Bei province Center for Disease control and prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056519
- Sponsor's protocol ID
- F20210719
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Random, Double -Blind, Placebo Control Phase Ⅰ Trail to Evaluate the Safety and Immunogenicity of Live Attenuated Influenza Vaccine in 3-59y Healthy People
- ClinicalTrials.gov ID
- NCT05056519
- Acronym / sponsor ID
- F20210719
- Conditions
- Influenza Prevention
- Keywords
- Safety, Immunogenicity, Live Attenuated Influenza Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Collaborators
- He Bei province Center for Disease control and prevention
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 24 Sep 2021 (actual)
- 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.
Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase Ⅰ trail is to evaluate the safety of LAVI(non freeze-dried). The secondary objective is to evaluate the immunogenicity of LAVI(non freeze-dried).
Detailed description
Totally 160 health people aged 3-59 years old will be divided into two age group, containing 80 in 18-59 years old and 80 in 3-19 years old. All subjects will receive vaccination either LAVI or placebo in a ratio of 3:1.
All subjects will be collected any adverse events within 30 days and any serious adverse events within 6 months for safety evaluation.
All subjects will be collected blood sample and nasopharyngeal swab for immunogenicity evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Totally 160 in 3-59 years old healthy people will be divided into two age group, which contain 80 people in 18-59 years old and 80 people in 3-17 years old. In each age group, subjects will be randomly divided into vaccine group and placebo group in a ratio of 3:1.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: Live Attenuated Influenza VaccineHealthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine |
| Placebo group | Placebo comparator | Biological: Live Attenuated Influenza Vaccine placeboHealthy people in placebo group will receive a dose of placebo |
Who may qualify
- Ages
- 3 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy volunteers aged in 3-59 years old.
- Had not received vaccination of Influenza vaccine in the past half of years.
- Had not infected with Influenza virus.
- This trail has been agreed by volunteers or his/her legal guardian.
- Volunteers or his/her legal guardian will fellow this trail protocol.
Key exclusion criteria (9 listed)
- People from 18-59 age group with abnormal laboratory index. (slight abnormality is except if judged with no clinical significance by doctors.)
- People with fever before vaccination, temperature higher than 37.0 ℃
- Females in suckling period, pregnancy (pregnancy test positive) or prepared to be pregnant
- People given whole blood, plasma or immunoglobulin therapy within 3 months before vaccination
- According to judgement of researchers, the subjects have any other factors that are not appropriate for this clinical trials.
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 |
|---|---|---|
| Live Attenuated Influenza VaccineLive Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus. | Biological | Experimental group |
| Live Attenuated Influenza Vaccine placeboLive Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus. | Biological | Placebo group |
Primary outcome
Number of participants with adverse events as assessed by SAS v9.4
Time frame: Within 31 days after vaccination
The incidence rate of adverse events in all subjects
Number of participants with laboratory examination abnormity as assessed by SAS v9.4Clinical laboratory examination
Time frame: 3 days after vaccination
The incidence rate of abnormal of Blood routine, blood biochemical and urine in The incidence rate of abnormality of blood routine, blood biochemical and urine routine in 18-59 years age group
Number of participants with virus Shedding as assessed by SAS v9.4
Time frame: within 16 days after vaccination
The nasal secretions of Subjects in 18-59 years age group will be taken and be tested
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
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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.
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, China
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 Live Attenuated Influenza Vaccine in people with Influenza Prevention, run by Changchun BCHT Biotechnology Co. at 1 site in China.
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 5 inclusion and 9 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 24 Sep 2021. 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 China. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as assessed by SAS v9.4 (time frame: Within 31 days after vaccination). The study lists 3 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 24 Sep 2021.