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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

9000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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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

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Live-Attenuated influenza Vaccine(LAIV)

Intervention Type BIOLOGICAL

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Interventions

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Live-Attenuated influenza Vaccine(LAIV)

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes