Clinical trial NCT02964065: A Trial on the Efficacy, Safety and Immunogenicity of Live-Attenuated Influenza Vaccine (LAIV)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial on the Efficacy, Safety and Immunogenicity of Live-Attenuated Influenza Vaccine (LAIV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza Vaccines
LAIV
Lead sponsor: Changchun BCHT Biotechnology Co.
Sponsor class: INDUSTRY
Collaborators: name: Simoon Record Pharma Information Consulting Co., Ltd.
name: National Institutes for Food and Drug Control, China
name: Baoding Municipal Center for Disease Control and Prevention, Hebei, P.R.China
name: Zhejiang Provincial Center for Disease Control and Prevention
name: Maoming Municipal Center for Disease Control and Prevention, Guangdong, P.R.China
name: Department of Medical Statistics, Fourth Military Medical University
First posted: 2016-11-15
Enrollment: 9000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: Percentage of Subjects With Symptomatic, Laboratory-confirmed(RT-PCR/ Virus Culture) Influenza Virus Infection(Vaccine-like Strains)
timeFrame: Through 2 weeks to 1 year post vaccination
Secondary outcomes:
measure: Percentage of Subjects With Symptomatic, Laboratory-confirmed(RT-PCR/ Virus Culture) Influenza Virus Infection(Regardless of Vaccine Match)
timeFrame: Through 2 weeks to 1 year post vaccination
measure: Percentage of Subjects with influenza-like illness caused by Influenza Virus Infection(Laboratory-confirmed by RT-PCR/ Virus Culture)
timeFrame: Through 2 weeks to 1 year post vaccination
measure: Adverse Events Occurring Within 30 Minutes of Administration of Study Vaccine
timeFrame: Through 30 minutes post vaccination
measure: Solicited Adverse Events
timeFrame: Through 14 days post vaccination
measure: Unsolicited Adverse Events
timeFrame: Through 30 days post vaccination
measure: Serious Adverse Events
timeFrame: Through 1 year post vaccination
measure: Geometric Mean Titers (GMT) of Hemagglutination Inhibition (HAI) Antibodies to each of the Influenza Strains in the Vaccine Received
timeFrame: 30 days post vaccination
measure: Percentage of subjects with antibody positive conversion to each of the Influenza Strains in the Vaccine Received.
timeFrame: 30 days post vaccination
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Institute of Biological Products and Materia Media
state: Guangdong
city: Shijiazhuang Shi
country: China
facility: Hebei Provincial Center for Disease Control and Prevention
state: Hebei
city: Hangzhou
country: China
facility: Zhejiang Provincial Center for Disease Control and Prevention
state: Zhejiang
Study officials:
References:
citation: 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.