Influenza PreventionPhase 4NCT06280144
Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine
A Phase 4 study testing Influenza Vaccine, Live, Nasal, Freeze-dried and Sterile water for inhalation in people with Influenza Prevention, run by Changchun BCHT Biotechnology Co. at 1 site in China.
Trial summary
To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of… Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Prevention
- What is being tested?
- Influenza Vaccine, Live, Nasal, Freeze-dried and Sterile water for inhalation
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,080 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2023to 30 Oct 2024
- Phase
- Phase 4
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Local residents aged between 3 and 17;
- People who signed the informed consent form and could actively cooperate with the study；
- Axillary body temperature of 37.0℃.
Who cannot join
- Subjects who meet the contraindications and precautions specified in the vaccine instructions:
- Those known to be allergic to any ingredients of this product, including eggs, excipients, gentamycin sulfate;
- Patients with acute disease, severe chronic disease, the acute onset of chronic disease and fever;
- Women in pregnancy;
- Patients with Leigh syndrome treated with aspirin or aspirin-containing drugs;
- Immunodeficient, immunocompromised, or under immunosuppressive therapy;
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- Patients with uncontrolled epilepsy and other progressive neurological diseases, patients with a history of Guillain-Barre syndrome; And g. patients with rhinitis (with a clear diagnosis and in the onset of rhinitis).
- Have received other clinical study drugs or were participating in other clinical trials within 1 month before entering the cohort.
- Have received any influenza vaccine during this natural year before entering the study
- Those who have been diagnosed with influenza in this natural year before entering the study.
- Any condition that the investigator judged to affect the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Study site
Chifeng, Inner Mongolia, 024000
Xiaoling Tian, 13848710296, txlingok@126.com
About this study
Official title: Multi-center, Randomized, Double-blind, Placebo-controlled Trial of a Live Attenuated Influenza Vaccine in People Aged 3-17
To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.
To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine.
Read the detailed description
Main end point:
Primary influenza protective effect endpoint Protective effect of 14 days on laboratory-confirmed influenza cases. Protective effect of 14 days after receiving lyophilized nasal spray live attenuated influenza vaccine on laboratory-confirmed serotype influenza cases.
Secondary endpoints:
Secondary point of secondary endpoint Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 0 days later on laboratory-confirmed influenza cases.
Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days later on clinically diagnosed influenza cases.
Protective effect of live attenuated influenza-like vaccine 14 days against influenza-like cases.
safety Incidence of adverse events and serious adverse events within 0-30 days after immunization.
Study on detoxification Proproportion of vaccine attenuated proportion and vaccine attenuated content (titer) at different times after vaccination (days 3,7,15).
Exploration endpoint:
14 days after the freeze-dried nose vaccine, the vaccine was protective for the detection of COVID-19 cases.
- Conditions
- Influenza Prevention
- Being tested
- Influenza Vaccine, Live, Nasal, Freeze-dried, Sterile water for inhalation
- Keywords
- Protection effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Vaccine, Live, Nasal, Freeze-driedBiological
The titer of live attenuated influenza virus containing A (H1N1) and A (H3N2) should not be less than 6.9 lg EID50, and the titer of live attenuated influenza B virus should not be less than 6.4 lg EID50
Sterile water for inhalationOther
Sterile water for inhalation
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Influenza Vaccine, Live, Nasal, Freeze-dried Receives: Biological: Influenza Vaccine, Live, Nasal, Freeze-dried |
| Placebo group | Placebo comparator | Sterile water for inhalation Receives: Other: Sterile water for inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary influenza protective effect endpoint
Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days on the incidence of laboratory-confirmed influenza cases
Measured: 7 months
Primary influenza protective effect endpoint
Protective effect of 14-day live attenuated influenza vaccine on the incidence of laboratory-confirmed cases of serotype influenza.
Measured: 7 months
Secondary outcomes (5)
Secondary protective efficacy endpoint
Protective effect of freeze-dried nasal spray live attenuated influenza vaccine after 0 days on the incidence of laboratory-confirmed influenza cases.
Measured: Seven months
Secondary protective efficacy endpoint
Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days later on the incidence of clinically diagnosed influenza cases.
Measured: Seven months
Secondary protective efficacy endpoint
Protective effect of 14 days on the incidence of influenza-like cases.
Measured: Seven months
Safety
Incidence of adverse events and serious adverse events within 0-30 days .AE at the inoculation site: runny nose / nasal congestion, sore throat Non-inoculation site (systemic) AEs (including vital signs): fever, cough, headache, fatigue, fatigue, nausea, vomiting, muscle pain, arthralgia, chills, anorexia, acute anaphylaxis (type I hypersensitivity).
Other AEs, SAEs, and pregnancy events incidence.
Measured: One month
Study on detoxification
Proproportion of vaccine attenuated proportion and vaccine attenuated content (titer) at different times after vaccination (days 3,7,15).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start22 Sep 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Oct 2024 (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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hu Bei province Center for Disease control and prevention, The Inner Mongolia Autonomous Region Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280144
- Sponsor's protocol ID
- PF20230428
- Status last verified
- Dec 2023
- First submitted
- 1 Sep 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double-blind, Placebo-controlled Trial of a Live Attenuated Influenza Vaccine in People Aged 3-17
- ClinicalTrials.gov ID
- NCT06280144
- Acronym / sponsor ID
- PF20230428
- Conditions
- Influenza Prevention
- Keywords
- Protection effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,080 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Collaborators
- Hu Bei province Center for Disease control and prevention, The Inner Mongolia Autonomous Region Center for Disease Control and Prevention
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 28 Feb 2024 (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 evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.
To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine.
Detailed description
Main end point:
Primary influenza protective effect endpoint Protective effect of 14 days on laboratory-confirmed influenza cases. Protective effect of 14 days after receiving lyophilized nasal spray live attenuated influenza vaccine on laboratory-confirmed serotype influenza cases.
Secondary endpoints:
Secondary point of secondary endpoint Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 0 days later on laboratory-confirmed influenza cases.
Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days later on clinically diagnosed influenza cases.
Protective effect of live attenuated influenza-like vaccine 14 days against influenza-like cases.
safety Incidence of adverse events and serious adverse events within 0-30 days after immunization.
Study on detoxification Proproportion of vaccine attenuated proportion and vaccine attenuated content (titer) at different times after vaccination (days 3,7,15).
Exploration endpoint:
14 days after the freeze-dried nose vaccine, the vaccine was protective for the detection of COVID-19 cases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: Influenza Vaccine, Live, Nasal, Freeze-driedInfluenza Vaccine, Live, Nasal, Freeze-dried |
| Placebo group | Placebo comparator | Other: Sterile water for inhalationSterile water for inhalation |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Local residents aged between 3 and 17;
- People who signed the informed consent form and could actively cooperate with the study；
- Axillary body temperature of 37.0℃.
Key exclusion criteria (11 listed)
- Subjects who meet the contraindications and precautions specified in the vaccine instructions:
- Have received other clinical study drugs or were participating in other clinical trials within 1 month before entering the cohort.
- Have received any influenza vaccine during this natural year before entering the study
- Those who have been diagnosed with influenza in this natural year before entering the study.
- Any condition that the investigator judged to affect the trial.
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 |
|---|---|---|
| Influenza Vaccine, Live, Nasal, Freeze-driedThe titer of live attenuated influenza virus containing A (H1N1) and A (H3N2) should not be less than 6.9 lg EID50, and the titer of live attenuated influenza B virus should not be less than 6.4 lg EID50 | Biological | Experimental group |
| Sterile water for inhalationSterile water for inhalation | Other | Placebo group |
Primary outcome
Primary influenza protective effect endpoint
Time frame: 7 months
Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days on the incidence of laboratory-confirmed influenza cases
Primary influenza protective effect endpoint
Time frame: 7 months
Protective effect of 14-day live attenuated influenza vaccine on the incidence of laboratory-confirmed cases of serotype influenza.
5 secondary outcomes
Secondary protective efficacy endpoint
Time frame: Seven months
Secondary protective efficacy endpoint
Time frame: Seven months
Secondary protective efficacy endpoint
Time frame: Seven months
Safety
Time frame: One month
Study on detoxification
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza Vaccine, Live, Nasal, Freeze-dried and Sterile water for inhalation 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 3 inclusion and 11 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 28 Feb 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Xibao Huang (027-87652133, hxb6407@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary influenza protective effect endpoint (time frame: 7 months). 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 28 Feb 2024.