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InfluenzaPhase 3NCT02964065

A Trial on the Efficacy, Safety and Immunogenicity of Live-Attenuated Influenza Vaccine (LAIV)

A Phase 3 study testing Live-Attenuated influenza Vaccine(LAIV) in people with Influenza, run by Changchun BCHT Biotechnology Co. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years. Read more about this study

Who is it for?
Ages 3 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Live-Attenuated influenza Vaccine(LAIV)
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9,000 participants
Where
3 sitesChina
Study dates
Nov 2016to Aug 2017
Phase
Phase 3
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

  • Healthy children and adolescents aged 3-17 years old.
  • Informed consent obtained and signed by subjects or legal guardians prior to screening. Children or adolescents aged 10-17 yrs need sign informed consent by themselves.
  • Willing to participate for the planned duration of the study, including availability for follow-up.

Who cannot join

  • Any investigational or unregistered product (drug, vaccine or device) was used within 30 days, or planned to be used during the trial.
  • have been vaccinated with any influenza vaccine within 6 months, or plan to be vaccinated during the trail.
  • Immunosuppressive agents or other immunomodulatory drugs (defined as continuous use for more than 14 days) were used over a 3-month period.
  • Immunoglobulins and / or any blood products were used within 3 months, or planned to be used before blood collection.
  • History of Guillain-Barré syndrome; History of hypersensitivity to any component of the LAIV, including egg or egg products.
  • Severe allergic reactions after vaccination (including anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis).
Show all 11Show fewer
  • Acute diseases , infections or febrile diseases (axillary temperature ≥37.1℃) on the day of vaccination.
  • Obvious coagulation dysfunction or History of anticoagulant therapy
  • Aspirin is being used(Salicylates are a potential risk factor for Reye syndrome)
  • Known or suspected immune deficiency diseases or immunosuppressed
  • Heart disease, respiratory diseases (including severe rhinitis, nasal deformities, polyps, etc.), liver disease, kidney disease, mental disorders, chronic infections etc.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Guangdong Provincial Institute of Biological Products and Materia Media

    Guangzhou, Guangdong, 511430

  • Zhejiang Provincial Center for Disease Control and Prevention

    Hangzhou, Zhejiang, 310051

  • Hebei Provincial Center for Disease Control and Prevention

    Shijiazhuang, Hebei, 050021

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial on the Efficacy, Safety and Immunogenicity of Live-Attenuated Influenza Vaccine (LAIV)

This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years.

Read the detailed description

This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years old. The subjects will be randomized in a 1:1 ratio of LAIV to placebo. Each subject will be vaccinated with a single dose of LAIV or Placebo. For evaluation of efficacy, subjects meeting the protocol-defined clinical case definition the 14th day post-vaccination will have a nasal swab collected for testing by RT-PCR or virus culture for evidence of influenza virus infection. All adverse events will be collected 30 minutes, 0-30 days after vaccination and all serious adverse events during the entire trial period. Blood samples will be collected from a part of subjects before vaccination and at the 30th day after immunization. Serum samples will be centrifuged for detection of antibodies to H1N1, H3N2, and influenza B.

Conditions
Influenza
Being tested
Live-Attenuated influenza Vaccine(LAIV), Placebo
Keywords
Influenza Vaccines, LAIV
Medical subject headings
Influenza, Human

What participants receive

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

  • Live-Attenuated influenza Vaccine(LAIV)Biological

  • PlaceboBiological

Study groups in NCT02964065
Study groupRoleWhat they receive
LAIVExperimentala single dose of Live-Attenuated influenza Vaccine;Dose: 0.2 ml; Each dose contains not less than 6.9 lg EID50 of type A live attenuated influenza virus reassortants(H1N1 and H3N2), and not less than 6.4 lg EID50 of type B live attenuated influenza virus reassortants.
Receives: Biological: Live-Attenuated influenza Vaccine(LAIV)
PlaceboPlacebo comparatora single dose of Placebo. Inactivated placebo will be identical to LAIV in appearance, ingredients and concentrations, attenuated influenza virus free.
Receives: Biological: Placebo

What is being measured

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

  1. Percentage of Subjects With Symptomatic, Laboratory-confirmed(RT-PCR/ Virus Culture) Influenza Virus Infection(Vaccine-like Strains)

    Measured: Through 2 weeks to 1 year post vaccination

Secondary outcomes (8)

  1. Percentage of Subjects With Symptomatic, Laboratory-confirmed(RT-PCR/ Virus Culture) Influenza Virus Infection(Regardless of Vaccine Match)

    Measured: Through 2 weeks to 1 year post vaccination

  2. Percentage of Subjects with influenza-like illness caused by Influenza Virus Infection(Laboratory-confirmed by RT-PCR/ Virus Culture)

    Measured: Through 2 weeks to 1 year post vaccination

  3. Adverse Events Occurring Within 30 Minutes of Administration of Study Vaccine

    Measured: Through 30 minutes post vaccination

  4. Solicited Adverse Events

    Measured: Through 14 days post vaccination

  5. Unsolicited Adverse Events

    Measured: Through 30 days post vaccination

  6. Serious Adverse Events

    Measured: Through 1 year post vaccination

  7. Geometric Mean Titers (GMT) of Hemagglutination Inhibition (HAI) Antibodies to each of the Influenza Strains in the Vaccine Received

    Measured: 30 days post vaccination

  8. Percentage of subjects with antibody positive conversion to each of the Influenza Strains in the Vaccine Received.

    Measured: 30 days 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 posted15 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionAug 2017

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
9,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02964065
Sponsor's protocol ID
F20160728
Status last verified
Sep 2017
First submitted
11 Nov 2016
Last updated
14 Sep 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Ai L, Gao Z, Lv H, Zhang J, Xu N, Zhao H, Lu Q, Zhu H, Shi N, Wei W, Liu D, Yu Q. Immunogenicity and safety of live attenuated influenza vaccine in children aged 3-17 years in China. Vaccine. 2025 Feb 6;46:126653. doi: 10.1016/j.vaccine.2024.126653. Epub 2024 Dec 26.

    PubMed 39729925

  • Wang S, Zheng Y, Jin X, Gan Z, Shao Y, Zhu C, Hu X, Liang Z, Chen Y, Xing B, Lv H, Xu N. Efficacy and safety of a live attenuated influenza vaccine in Chinese healthy children aged 3-17 years in one study center of a randomized, double-blind, placebo-controlled phase 3 clinical trial, 2016/17 season. Vaccine. 2020 Aug 27;38(38):5979-5986. doi: 10.1016/j.vaccine.2020.07.019. Epub 2020 Jul 31.

    PubMed 32747213

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Live-Attenuated influenza Vaccine(LAIV) in people with Influenza, run by Changchun BCHT Biotechnology Co. at 3 sites 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: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Subjects With Symptomatic, Laboratory-confirmed(RT-PCR/ Virus Culture) Influenza Virus Infection(Vaccine-like Strains) (time frame: Through 2 weeks to 1 year 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 NCT02964065, which also lists 2 linked publications.

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 14 Sep 2017.

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