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CompletedNCT02964065Updated Sep 14, 2017

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

A Phase 3 interventional study of Live-Attenuated influenza Vaccine(LAIV) and Placebo in Influenza, sponsored by Changchun BCHT Biotechnology Co.. Completed at 3 sites in China. Open to participants aged 3 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-14.

Sponsored by Changchun BCHT Biotechnology Co. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
9,000
Allocation
Randomized
Ages
3 Years to 17 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Influenza

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Keywords

  • Influenza Vaccines
  • LAIV
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 9,000 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Changchun BCHT Biotechnology Co. is the lead sponsor of 20 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy children and adolescents aged 3-17 years old.
  2. 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.
  3. Willing to participate for the planned duration of the study, including availability for follow-up.

Exclusion criteria

Exclusion Criteria:

  1. Any investigational or unregistered product (drug, vaccine or device) was used within 30 days, or planned to be used during the trial.
  2. have been vaccinated with any influenza vaccine within 6 months, or plan to be vaccinated during the trail.
  3. Immunosuppressive agents or other immunomodulatory drugs (defined as continuous use for more than 14 days) were used over a 3-month period.
  4. Immunoglobulins and / or any blood products were used within 3 months, or planned to be used before blood collection.
  5. History of Guillain-Barré syndrome; History of hypersensitivity to any component of the LAIV, including egg or egg products.
  6. Severe allergic reactions after vaccination (including anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis).
  7. Acute diseases , infections or febrile diseases (axillary temperature ≥37.1℃) on the day of vaccination.
  8. Obvious coagulation dysfunction or History of anticoagulant therapy
  9. Aspirin is being used(Salicylates are a potential risk factor for Reye syndrome)
  10. Known or suspected immune deficiency diseases or immunosuppressed
  11. Heart disease, respiratory diseases (including severe rhinitis, nasal deformities, polyps, etc.), liver disease, kidney disease, mental disorders, chronic infections etc.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
9,000 participants (actual)

Study arms

  • Experimental
    LAIV

    a 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.

    Biological: Live-Attenuated influenza Vaccine(LAIV)

  • Placebo comparator
    Placebo

    a single dose of Placebo. Inactivated placebo will be identical to LAIV in appearance, ingredients and concentrations, attenuated influenza virus free.

    Biological: Placebo

Interventions

  • BiologicalLive-Attenuated influenza Vaccine(LAIV)
  • BiologicalPlacebo
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 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)

    Time frame: Through 2 weeks to 1 year post vaccination

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

    Time frame: Through 30 minutes post vaccination

  4. Solicited Adverse Events

    Time frame: Through 14 days post vaccination

  5. Unsolicited Adverse Events

    Time frame: Through 30 days post vaccination

  6. Serious Adverse Events

    Time frame: 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

    Time frame: 30 days post vaccination

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

    Time frame: 30 days post vaccination

07

Study locations

3 sites
  • Guangdong Provincial Institute of Biological Products and Materia Media
    Guangzhou, Guangdong 511430, China
  • Hebei Provincial Center for Disease Control and Prevention
    Shijiazhuang Shi, Hebei 050021, China
  • Zhejiang Provincial Center for Disease Control and Prevention
    Hangzhou, Zhejiang 310051, China
08

References and documents

Publications

  • 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02964065
Lead sponsor
Changchun BCHT Biotechnology Co.
Collaborators
Simoon Record Pharma Information Consulting Co., Ltd., National Institutes for Food and Drug Control, China, Baoding Municipal Center for Disease Control and Prevention, Hebei, P.R.China, Zhejiang Provincial Center for Disease Control and Prevention, Maoming Municipal Center for Disease Control and Prevention, Guangdong, P.R.China, Department of Medical Statistics, Fourth Military Medical University
Responsible party
Sponsor
First posted
Nov 15, 2016
Start date
Nov 2016
Primary completion
Aug 2017
Last update
Sep 14, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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