Influenza Clinical Trial
Official title:
Immunogenicity and Safety of a Single Dose (Subjects From 3 Years of Age) or Two Doses Given 28 Days Apart (Children From 6 to 35 Months of Age) of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China
The main purpose of this trial is to describe the product profile in terms of immunogenicity
and safety following administration of trivalent influenza vaccine (split-virion,
inactivated) produced at Shenzhen (SP Shz TIV).
Primary objective:
- To describe in each group the immune response induced by a single dose (subjects aged ≥
3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV.
Secondary objective:
- To describe in each group the safety profile of the vaccine after a single dose
(subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35
months).
Healthy subjects will be included to receive one or two doses of SP Shz TIV The study will assess the immunogenicity and safety of a single dose (in subjects from 3 years) or two doses of SP Shz TIV vaccine given 28 days apart (pediatric population from 6 to 35 months). ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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