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Prevention of InfluenzaPhase 3NCT07133802

Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination

A Phase 3 study testing Test Group in people with Prevention of Influenza, run by Changchun BCHT Biotechnology Co..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

A Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Prevention of Influenza
What is being tested?
Test Group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,680 participants
Where
No sites listed yet
Study dates
Aug 2025to Jul 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy participants aged 18-59 years
  • Capable of providing informed consent in person
  • Willing and able to comply with all clinical trial requirements

Who cannot join

  • Axillary temperature >37.0°C on enrollment day *
  • Received any influenza vaccine within the past 6 months or plans to receive other influenza vaccines during the trial
  • History of laboratory-confirmed influenza (by clinical, serological, or microbiological methods) within the past 6 months
  • Female participants of childbearing potential with positive urine pregnancy test, currently breastfeeding, or planning pregnancy within 6 months
  • Acute phase of any infectious disease/chronic illness within 3 days, or recent use (≤3 days) of antipyretics/analgesics/antihistamines *
  • History of severe allergies requiring medical intervention (e.g., anaphylaxis, angioedema, Arthus reaction) or hypersensitivity to vaccine components (egg proteins, gentamicin sulfate, etc.)
Show all 18Show fewer
  • Known malignancies, autoimmune diseases (e.g., SLE, rheumatoid arthritis), or immunodeficiency (HIV, organ transplantation, etc.)
  • Asplenia, functional asplenia, or any splenectomy history
  • Use of immunosuppressants/immunomodulators (e.g., systemic corticosteroids >14 days) within 6 months or planned use during study
  • Congenital anomalies affecting organ function, uncontrolled hypertension (≥140/90 mmHg despite treatment), or severe hepatic/renal diseases (e.g., diabetes-complicated)
  • Active asthma or clinical remission for <12 months
  • History or family history of neurological/psychiatric disorders (e.g., epilepsy, Guillain-Barré syndrome)
  • Salicylate use (e.g., aspirin) within 30 days or planned use within 6 weeks post-vaccination
  • Nasal abnormalities potentially affecting vaccine administration (e.g., active allergic rhinitis with medication, ongoing nasal sprays)
  • Blood products/immunoglobulin administration within 3 months or planned use during trial
  • Live-attenuated vaccines within 14 days or subunit/inactivated vaccines within 7 days prior to enrollment *
  • Participation in other clinical trials within 1 month or concurrent involvement in interventional studies
  • Any condition deemed by investigators to compromise trial integrity

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

huan xiao li contact

0431-87078176

lixiaohuan@bchtpharm.com

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine in Adults Aged 18-59 Years

A Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination

Being tested
Placebo Group, Test Group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo GroupBiological

    Each human dose: 0.2 mL

  • Test GroupBiological

    Each human dose is 0.2 mL

Study groups in NCT07133802
Study groupRoleWhat they receive
Nasal Spray Live Attenuated Influenza VaccineExperimentalNot described
Receives: Biological: Test Group
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Protective Efficacy

    To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed influenza in participants aged 18-59 years at 14 days post-vaccination

    Measured: at 14 days post-vaccination

Secondary outcomes (7)

  1. Protective Efficacy

    To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed vaccine-matched influenza in participants aged 18-59 years at 14 days post-vaccination

    Measured: at 14 days post-vaccination

  2. Protective Efficacy

    To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed influenza in participants aged 18-59 years post-vaccination

    Measured: Throughout the entire study period

  3. Protective Efficacy

    To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed, vaccine-matched influenza in participants aged 18-59 years post-vaccination

    Measured: Throughout the entire study period

  4. Safety

    Incidence of solicited adverse events (local and systemic) within 14 days post-vaccination

    Measured: 14 days post-vaccination

  5. Safety

    Incidence of unsolicited adverse events within 30 days post-vaccination

    Measured: 30 days post-vaccination

  6. Safety

    Incidence of serious adverse events (SAEs) in all participants from vaccination to end of study

    Measured: During the study period

  7. Safety

    Viral shedding assessment at Day 3, Day 7, and Day 15 post-vaccination

    Measured: Day 15 post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
6,680 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07133802
Sponsor's protocol ID
B1506-20250113
Status last verified
Aug 2025
First submitted
14 Aug 2025
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Test Group in people with Prevention of Influenza, 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 3 inclusion and 18 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: opening soon, as of the sponsor's last update on 21 Aug 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact huan xiao li (0431-87078176, lixiaohuan@bchtpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Protective Efficacy (time frame: at 14 days post-vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07133802.

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 21 Aug 2025.

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