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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Live-Attenuated influenza Vaccine(LAIV)

Placebo

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza Vaccines, LAIV

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).
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.

Sites / Locations

Guangdong Provincial Institute of Biological Products and Materia Media
Hebei Provincial Center for Disease Control and Prevention
Zhejiang Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LAIV

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Adverse Events Occurring Within 30 Minutes of Administration of Study Vaccine

Solicited Adverse Events

Unsolicited Adverse Events

Serious Adverse Events

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

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

Full Information

NCT ID

NCT02964065

First Posted

November 11, 2016

Last Updated

September 13, 2017

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

1. Study Identification

Unique Protocol Identification Number

NCT02964065

Brief Title

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

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Changchun BCHT Biotechnology Co.

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza Vaccines, LAIV

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

9000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LAIV

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Live-Attenuated influenza Vaccine(LAIV)

Intervention Type

Biological

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

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

Title

Adverse Events Occurring Within 30 Minutes of Administration of Study Vaccine

Time Frame

Through 30 minutes post vaccination

Title

Solicited Adverse Events

Time Frame

Through 14 days post vaccination

Title

Unsolicited Adverse Events

Time Frame

Through 30 days post vaccination

Title

Serious Adverse Events

Time Frame

Through 1 year post vaccination

Title

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

Title

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

Time Frame

30 days post vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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). 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.

Facility Information:

Facility Name

Guangdong Provincial Institute of Biological Products and Materia Media

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

511430

Country

China

Facility Name

Hebei Provincial Center for Disease Control and Prevention

City

Shijiazhuang Shi

State/Province

Hebei

ZIP/Postal Code

050021

Country

China

Facility Name

Zhejiang Provincial Center for Disease Control and Prevention

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310051

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32747213

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.

Results Reference

derived

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

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