Trials / Completed
CompletedNCT02964065
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 9,000 (actual)
- Sponsor
- Changchun BCHT Biotechnology Co. · Industry
- Sex
- All
- Age
- 3 Years – 17 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Live-Attenuated influenza Vaccine(LAIV) | |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2017-08-01
- First posted
- 2016-11-15
- Last updated
- 2017-09-14
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02964065. Inclusion in this directory is not an endorsement.