RandomizedNCT04825340
To Explore a Bridging Index for the Effectiveness of the Clinical Trial
A study testing Nasal Spray Lyophilized Live Attenuated Influenza Vaccine in people with Randomized, run by Changchun BCHT Biotechnology Co..
Trial summary
To explore a bridging index for the effectiveness of the clinical trial with Nasal Spray Lyophilized Live Attenuated Influenza Vaccine Read more about this study
- Who is it for?
- Ages 3 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Randomized
- What is being tested?
- Nasal Spray Lyophilized Live Attenuated Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2021to 25 Mar 2022
- Phase
- Interventional
- 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 volunteer aged 3~59 years old；
- no vaccination with any influenza vaccine within the past year；
- no catching any influenza or flu like symptoms （axillary temperature ≥ 38℃， accompanied by cough or sore throat ）；
- influenza susceptible individual（any serum Hi antibody level of H1N1, H3N2 and B≦1:10）；
- with informed consent obtained from the volunteer and / or guardian；
- willing of volunteers and / or guardians to comply with the requirements of the clinical trial protocol.
Who cannot join
- Known allergy individual to any ingredient of this product, including egg protein, subsidiary material and/or gentamycin sulfate;
- patients with acute disease, severe chronic disease, acute attack of chronic disease and/or fever (axillary temperature ≥ 37.3℃ on the day of immunisation);
- pregnancy (enquire);
- patients with Leigh syndrome treated with aspirin or aspirin containing drugs;
- patients with immunodeficiency or receiving immunosuppressive therapy;
- patients with uncontrolled epilepsy and other progressive nervous system diseases, with a history of Guillain Barre syndrome;
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- patients with rhinitis or other nasal abnormalities judged by clinicians that may affect vaccination or sample collection;
- accept any immunoglobulin and / or any blood products within 3 months, or plan to use them during the study (until post immunization blood sample collection);
- .taking anti influenza drugs in the past 48 hours;
- .any situation that the researchers believe may affect the study.
About this study
Official title: To Explore a Bridging Index for the Effectiveness of the Clinical Trial With Nasal Spray Lyophilized Live Attenuated Influenza Vaccine
To explore a bridging index for the effectiveness of the clinical trial with Nasal Spray Lyophilized Live Attenuated Influenza Vaccine
Read the detailed description
With a randomized, blind, parallel placebo-controlled design, to screen the susceptible individuals aged 3~59 years old whose titers of either of Hi antibody level of H1N1, H3N2 or B are not higher than 1:10 prior immunization , in which all persons are to be assigned into the two subgroups (aged 3~17 and 18~59 years old) with radio of 1:1, individually. All persons of each age subgroups are to be randomly assigned into the two groups (vaccine or placebo group) with th radio of 2:1 via intranasal injection of one dose of the study vaccine or placebo. The blood samples are to be collected prior immunisation and on the 21st day post immunisation, individually, the nasopharyngeal swab samples are also to be done prior immunisation and on the 10th day and 21st day post immunisation, individually, and the levels of serum HI antibody and mucous sIgA antibody are to be compared between the two groups, respectively.
- Conditions
- Randomized
- Being tested
- Nasal Spray Lyophilized Live Attenuated Influenza Vaccine
- Keywords
- Influenza Vaccine Nasal Spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Spray Lyophilized Live Attenuated Influenza VaccineBiological
0.2 ml/vial, 0.2ml/dose/per person
| Study group | Role | What they receive |
|---|---|---|
| Study vaccine | Experimental | Nasal Spray Lyophilized Live Attenuated Influenza Vaccine Receives: Biological: Nasal Spray Lyophilized Live Attenuated Influenza Vaccine |
| Placebo | Placebo comparator | commercial normal saline Receives: Biological: Nasal Spray Lyophilized Live Attenuated Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The GMTs of serum HI antibodies of all H1N1, H3N2 and B
The GMTs of serum HI antibodies of all H1N1, H3N2 and B on the 21st day post immunization;
Measured: 0-21 days
GMTs of HI sIgA antibodies of all H1N1, H3N2 and B
The mucous GMTs of HI sIgA antibodies of all H1N1, H3N2 and B on the 10th and 21st day post immunization;
Measured: 10-21 days
Secondary outcomes (1)
The ratios and 95% CI of the GMTs of serum HI antibodies of all H1N1, H3N2 and B
The ratios and 95% CI of the GMTs of serum HI antibodies of all H1N1, H3N2 and B on the 21st day post immunization;
Measured: 0-21days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start16 Apr 2021 (estimated)
- Primary completion25 Mar 2022 (estimated)
- Study completion25 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RandomizedStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825340
- Sponsor's protocol ID
- F202110111
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore a Bridging Index for the Effectiveness of the Clinical Trial With Nasal Spray Lyophilized Live Attenuated Influenza Vaccine
- ClinicalTrials.gov ID
- NCT04825340
- Acronym / sponsor ID
- F202110111
- Conditions
- Randomized
- Keywords
- Influenza Vaccine Nasal Spray
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2021 (estimated)
- Primary completion
- 25 Mar 2022 (estimated)
- Study completion
- 25 Mar 2022 (estimated)
- First posted
- 1 Apr 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.
To explore a bridging index for the effectiveness of the clinical trial with Nasal Spray Lyophilized Live Attenuated Influenza Vaccine
Detailed description
With a randomized, blind, parallel placebo-controlled design, to screen the susceptible individuals aged 3~59 years old whose titers of either of Hi antibody level of H1N1, H3N2 or B are not higher than 1:10 prior immunization , in which all persons are to be assigned into the two subgroups (aged 3~17 and 18~59 years old) with radio of 1:1, individually. All persons of each age subgroups are to be randomly assigned into the two groups (vaccine or placebo group) with th radio of 2:1 via intranasal injection of one dose of the study vaccine or placebo. The blood samples are to be collected prior immunisation and on the 21st day post immunisation, individually, the nasopharyngeal swab samples are also to be done prior immunisation and on the 10th day and 21st day post immunisation, individually, and the levels of serum HI antibody and mucous sIgA antibody are to be compared between the two groups, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study vaccine | Experimental | Biological: Nasal Spray Lyophilized Live Attenuated Influenza VaccineNasal Spray Lyophilized Live Attenuated Influenza Vaccine |
| Placebo | Placebo comparator | Biological: Nasal Spray Lyophilized Live Attenuated Influenza Vaccinecommercial normal saline |
Who may qualify
- Ages
- 3 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- healthy volunteer aged 3~59 years old；
- no vaccination with any influenza vaccine within the past year；
- no catching any influenza or flu like symptoms （axillary temperature ≥ 38℃， accompanied by cough or sore throat ）；
- influenza susceptible individual（any serum Hi antibody level of H1N1, H3N2 and B≦1:10）；
- with informed consent obtained from the volunteer and / or guardian；
Key exclusion criteria (10 listed)
- Known allergy individual to any ingredient of this product, including egg protein, subsidiary material and/or gentamycin sulfate;
- patients with acute disease, severe chronic disease, acute attack of chronic disease and/or fever (axillary temperature ≥ 37.3℃ on the day of immunisation);
- pregnancy (enquire);
- patients with Leigh syndrome treated with aspirin or aspirin containing drugs;
- patients with immunodeficiency or receiving immunosuppressive therapy;
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 |
|---|---|---|
| Nasal Spray Lyophilized Live Attenuated Influenza Vaccine0.2 ml/vial, 0.2ml/dose/per person | Biological | Placebo, Study vaccine |
Primary outcome
The GMTs of serum HI antibodies of all H1N1, H3N2 and B
Time frame: 0-21 days
The GMTs of serum HI antibodies of all H1N1, H3N2 and B on the 21st day post immunization;
GMTs of HI sIgA antibodies of all H1N1, H3N2 and B
Time frame: 10-21 days
The mucous GMTs of HI sIgA antibodies of all H1N1, H3N2 and B on the 10th and 21st day post immunization;
1 secondary outcome
The ratios and 95% CI of the GMTs of serum HI antibodies of all H1N1, H3N2 and B
Time frame: 0-21days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Spray Lyophilized Live Attenuated Influenza Vaccine in people with Randomized, run by Changchun BCHT Biotechnology Co..
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 10 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 13 Apr 2021. 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.
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?
The GMTs of serum HI antibodies of all H1N1, H3N2 and B (time frame: 0-21 days). The study lists 2 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 13 Apr 2021.