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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Placebo; Biological: Live-Attenuated influenza Vaccine(LAIV)

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.

• Study Type: Interventional
• Enrollment (Actual): 9000
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects With Symptomatic, Laboratory-confirmed(RT-PCR/ Virus Culture) Influenza Virus Infection(Vaccine-like Strains)	Through 2 weeks to 1 year post vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects With Symptomatic, Laboratory-confirmed(RT-PCR/ Virus Culture) Influenza Virus Infection(Regardless of Vaccine Match)	Through 2 weeks to 1 year post vaccination
Percentage of Subjects with influenza-like illness caused by Influenza Virus Infection(Laboratory-confirmed by RT-PCR/ Virus Culture)	Through 2 weeks to 1 year post vaccination
Adverse Events Occurring Within 30 Minutes of Administration of Study Vaccine	Through 30 minutes post vaccination
Solicited Adverse Events	Through 14 days post vaccination
Unsolicited Adverse Events	Through 30 days post vaccination
Serious Adverse Events	Through 1 year post vaccination
Geometric Mean Titers (GMT) of Hemagglutination Inhibition (HAI) Antibodies to each of the Influenza Strains in the Vaccine Received	30 days post vaccination
Percentage of subjects with antibody positive conversion to each of the Influenza Strains in the Vaccine Received.	30 days post vaccination

Collaborators and Investigators

• Sponsor: Changchun BCHT Biotechnology Co.
• Collaborators: National Institutes for Food and Drug Control, China; Simoon Record Pharma Information Consulting Co., Ltd.; Zhejiang Provincial Center for Disease Control and Prevention; Baoding Municipal Center for Disease Control and Prevention, Hebei, P.R.China; Maoming Municipal Center for Disease Control and Prevention, Guangdong, P.R.China; Department of Medical Statistics, Fourth Military Medical University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: November 11, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Influenza Vaccines; LAIV
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: F20160728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No